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CALIFORNIA STATE UNIVERSITY, NORTHRIDGE

PERCEPTION OF SAFETY AND

TASTE ACCEPTANCE OF

A thesis submitted in partial satisfaction of the requirements for the degree of Master of Science in

Home Economics

by

Kathleen A. Freund

January, 1987

' 0 The Thesis of Kathleen A. Freund is approved:

Lillie M. Grossman, Dr. P.H.

Ann R. Stasch, Ph.D., Chair

California State University, Northridge

ii

ACKNOWLEDGEMENTS

Sincere appreciation is extended to committee chair­ person, Dr. Ann R. Stasch, for her friendship, patience, guidance, and support throughout the many years of my academic career and in the development of this thesis.

Special thanks to committee member, Dr. Lillie

Grossman, for her sponsorship and continued support during the completion of this thesis.

Sincere thanks to committee member, Dr. Marjory

Joseph, for her advice and expertise throughout the process of this thesis.

Lastly, I would like to express my gratitude to my husband, Conrad R. Freund, and my friend, Rita Martino, for their assistance in data collection. Added thanks to

Brenda J. Soniega for her assistance with the final manuscript.

iv TABLE OF CONTENTS Page

DEDICATION . • . • ...... iii

ACKNOWLEDGEMENTS ...... iv

LIST OF TABLES • • vi ABSTRACT . . • . . . . . vii

CHAPTER

1. INTRODUCTION • • • . • 1

2. REVIEW OF LITERATURE ...... 6

3. PROCEDURE. . • • • • • • • . . • • . 33

4. RESULTS AND DISCUSSION • • . . • • • • • 35

5. SUMMARY, CONCLUSIONS AND RECOMM.ENDATIONS 46

REFERENCES ...... 49

APPENDIXES

A. QUESTIONNAIRE .•.. 57

B. CHI SQUARE ANALYSES •• ...... 63

v --

LIST OF TABLES

Page Table 37 1. Demographic Data . • . • ...... 42 2. Regular Use of Aspartame Products .• . . .

vi ABSTRACT

PERCEPTION OF SAFETY AND

TASTE ACCEPTANCE OF ASPARTAME

by

Kathleen A. Freund

Master of Science in Home Economics

January, 1987

The purpose of this study was to determine the subjects' acceptance of aspartame and their perception of its safety for consumption. One hundred twenty-one users of artificial sweeteners and/or artificially-sweetened products responded to a questionnaire which included questions on labeling, artificial sweetener use, taste preference and presence of aftertaste, safety, cost, and demographics.

The results of the study indicated that the majority of the subjects used artificial sweeteners to reduce caloric intake. Men were more likely than women to use artificial sweeteners to reduce intake. When given choices between aspartame and sugar or , aspar­ tame was chosen as the preferred sweetener. -Forty-five percent of the sample believed that aspartame was safer to consume than saccharin. Forty-one percent believed that neither aspartame nor saccharin was safe, but used

vii artificial sweeteners and/or artificially-sweetened

products on a regular basis. Almost all respondents had

read the warning labels on saccharin products, yet less

than half had read the warning on aspartame products.

Ninety-four percent did not know the meaning of the term

phenylketonuric or if it had any personal significance.

The most frequently used artificially-sweetened product was

carbonated soft drinks. Significance of selected questions

was determined using chi-square analysis at the 0.05 level

of significance.

6 f,.; ·{;;..,,·.· ·~ viii l 'i:: CHAPTER 1

INTRODUCTION

The demand for a low-calorie sweetener is not new.

Saccharin was discovered in 1879 and manufactured for distribution five years later. It was widely used as a sweetening agent during times of sugar shortages, especially during World Wars I and II. In 1937 cyclamate was introduced as the second non-nutritive sweetener.

Although less sweet than saccharin it did not have the same unpleasant aftertaste characteristic of saccharin

(40). In 1965 aspartame was discovered, but final approval by the and Drug Administration (FDA) for its use in dry was not issued until 1981. Two years later aspartame was approved for use in carbonated beverages.

Since cyclamate has been banned in the United States and the future of saccharin is uncertain, aspartame appears to be the non-nutritive sweetener of choice although it, too, has come under attack. The advantage to having a safe non-nutritive sweetener available is that it allows greater variety in the diets of those with mellitus and other medical disorders as well as those who choose to restrict caloric intake.

JUSTIFICATION

Because aspartame is a relatively new compound, most

1 2

of the available literature deals with the effects of

aspartame on metabolic processes. The early studies were

conducted in part to secure approval by the FDA. There

continues to be ongoing controversy between the possible

side-effects from widespread use of aspartame and the

apparent safety of the product. This study attempted to

determine if the sample participating had accepted

aspartame as a beneficial addition to consumer products in

terms of taste acceptability and safety and if they had an

understanding of aspartame in terms of those who may be

sensitive to any possible side-effects. A questionnaire

designed to address the above issues was used to collect

data.

Dietitians and other professionals are

faced with providing therapeutic diets that will result in

patient compliance. This study was designed to make a

positive contribution to the literature by adding some

insight as to whether aspartame is an acceptable

alternative to or other non-nutritive sweeteners

and one that the patient views as safe for consumption.

OBJECTIVES

The purpose of this study was to determine the

acceptability of aspartame in terms of taste, perception

of safety, and awareness of restrictions for use by

individuals who use non-nutritive sweeteners. Specific

objectives included:

i:.L__ 3

1. To determine why the respondents used non­

nutritive sweeteners.

2. To determine if the respondents chose non­

nutritive sweeteners solely on the basis of

taste.

3. To determine if the respondents were aware of

warning labels on the non-nutritive sweeteners,

or foods containing them, which they purchased

and/or consumed.

4. To determine if the respondents perceived

aspartame as having fewer risks of side-effects

than saccharin.

ASSUMPTIONS

1. The questionnaire was a valid tool for

collecting data concerning respondents'

acceptance of aspartame as a beneficial addition

to consumer products in terms of taste

acceptability, safety, and consumer awareness of

potential risks to sensitive individuals.

2. The responses of the participants were

representative of, but limited to, those who

participated in the study.

3. The responses of the participants were truthful

and as accurate as possible.

LIMITATIONS

1. The non-random distribution of the questionnaire 4

was limited to subjects who used products that

contain non-nutritive sweeteners.

2. The geographical area of this study was limited

to residents of the Greater Los Angeles

Metropolitan Area.

DEFINITIONS OF TERMS

ASPARTAME - Chemical name: L-aspartyl-L- methyl . Non-nutritive sweetener. Trade names: , Nutrasweet.

CYCLAMATE - Chemical name: N-cyclohexylsulfamic . Artificial, non-nutritive sweetener. Banned for use in the United States by the FDA in September, 1970.

HETEROZYGOUS PHENYLKETONURICS - individuals who carry a recessive gene for .

NON-NUTRITIVE SWEETENERS - sweeteners that do not contain appreciable kilocalories; also called artificial sweeteners; include saccharin, cyclamate, and aspartame.

PHENYLKETONURIA (PKU) - a genetic disease in which the body cannot convert phenylalanine (an essential ) to tyrosine (another ) due to a missing (phenylalanine hydroxylase). Untreated PKU can result in damage to brain tissue and accompanying mental retardation, very light colored hair, and eczema.

PKU can be detected at birth and treated with a low­ phenylalanine . 5

SACCHARIN - Chemically known as: saccharin.

An artificial, non-nutritive sweetener. Trade names: Sweet

and Low, SugarTwin, and Sucaryl. CHAPTER 2

REVIEW OF LITERATURE

The first artificial sweetener, saccharin, was used originally as an antiseptic and as a food

(30). The discoveries of cyclamate and aspartame as possible sweetening agents were accidental. Cyclamate's sweet taste was noted by a at the University of

Illinois when some powder, a derivative of cyclohexyl­ sulfamic acid, touched a cigarette he was (31).

Aspartame was discovered while at Searle research laboratories were working to find an enzyme inhibitor as a possible treatment for ulcers (35).

Although none of these artificial sweeteners has proven to be completely satisfactory in terms of taste or safety, the consumer continues to demand an alternative to sugar.

HISTORICAL PERSPECTIVE

At the time of the discovery of saccharin in 1879

(40), the need for an artificial or non-nutritive sweetener was limited primarily to times of sugar shortages. In 1937 cyclamate was discovered (30). By combining these two products, saccharin for its intense sweetening properties and cyclamate for its absence of aftertaste, a satisfactory non-nutritive sweetener was available. Although sucrose or table sugar was the preferred sweetening agent, the demand

6 7

for a low calorie sweetener increased as people became more

weight and health conscious. Between 1937 and 1969 the use

of non-nutritive sweeteners increased tenfold due to the

popularity of diet soft drinks introduced in the late

1950's (40). Cyclamate was banned in 1969 after test

results suggested that it may have carcinogenic properties

(70) and that Abbott Laboratories, the manufacturer of

cyclamate, could not demonstrate "to a reasonable

certainty" that cyclamate was safe for consumption

(30). The National Academy of Sciences (NAS) has reviewed

the data on cyclamate and has stated, thus far, that

cyclamate itself is not a carcinogen; however, it may be a

cancer-promoter in that it could accelerate the potential

of other substances to cause cancer. The status of cycla­

mate could be changed once other concerns for safety have

been resolved. These concerns include possible genetic

damage and testicular atrophy (68).

In 1965, a scientist for G.D. Searle and Company

discovered aspartame, but aspartame was subject to years of

testing before approval could be obtained from the FDA.

The FDA initially approved Searle's petition and issued a

regulation authorizing the use of aspartame in certain dry

foods, subject to labeling laws, effectiv~ July 26, 1974

(64). Objections against the approval of aspartame were

filed, most notably by John W. Olney, M.D. and jointly,

Label, Inc. (Legal Action for Buyers• Education and

Labeling) and James S. Turner, Esq. (65). Meanwhile,

• r) 8

Searle voluntarily withheld aspartame from the market (40).

Turner and Olney waived their right to a formal evidentiary hearing conditioned upon the formation of a Public Board of

Inquiry (PBI) made up of qualified scientists from an outside agency (64). Before the PBI had convened, an audit of Searle's records revealed the need to validate that company's test data. The Searle studies were deemed valid by an outside panel of pathologists who reported their findings to the FDA in December, 1978 (31).

While the controversy over aspartame was being investigated, saccharin was the only non-nutritive sweetener available for consumption, but it too, had a dubious future. In 1977 the FDA proposed a ban on saccharin in response to the results of a Canadian study showing that high doses of this substance caused cancer in laboratory animals (53). Opposition to the ban was voiced by consumers and scientists who felt the Canadian study was misleading since the laboratory animals (rats) were fed the saccharin equivalent of 800 cans of diet soda per day (11).

Congress intervened, overruled the FDA proposal, and placed an eighteen-month moratorium on any regulatory action by the FDA. In addition Congress passed the Saccharin Study and Labeling Act (49). This law mandated further studies on saccharin safety and compliance with the Delaney Clause

in the Amendment to the Food, Drug, and

Cosmetic Act. The Delaney Clause states that "no substance

shall be added to foods that is known to cause cancer in 9

animals or at any dose level, no matter how small"

(70). Since research on saccharin had reported bladder

cancer in animals, the Delaney Clause was applicable to all

products that contained saccharin. More recently, the NAS

has concluded that:

saccharin is a low potency carcinogen in animals, that it is a potential cancer-causing agent in humans and that it seems to promote the cancer-causing properties of carcinogenic agents consumed with it (70) •

The American Council on Science and Health (ACSH) , a

national consumer education association, stated that

saccharin 11 is actually the weakest carcinogen ever

detected in an animal test, in terms of the amount needed

to produce tumors. 11 The latest extension on the saccharin

ban moratorium has been extended to April 22, 1987 (68).

PHYSICAL AND CHEMICAL

PROPERTIES OF ASPARTAME

Aspartame (L-aspartyl-L-phenylalanine methyl ester)

is a combination of two naturally occurring amino

and has the sweetening equivalency of 180-200 times that

of sucrose. In the dry form, aspartame is a white,

odorless powder stable for over one year at 104°F. It is

soluble and exhibits greater in acidic

solutions than in those with a neutral pH (23). In

solutions, aspartame gradually decomposes to the

diketopiperazine form - 3-carboxymethyl-6-benzyl-2,5-

piperazine (9). It was this diketopiperazine formation in - 10

soft drinks in storage that prompted Searle to voluntarily withhold aspartame from the market. Further testing on diketopiperazine established that it did not have carcinogenic properties (40), but the chemical change did result in a decrease in .

Boehm and Bada (9) investigated the racemization of the and phenylalanine (PHE) in aspartame at l00°C. This study indicated that neutral pH aspartame­ sweetened foods and beverages form the diketopiperazine product when heated to elevated temperatures.

It was also noted that the aspartic acid and PHE had been transformed to the D amino acid configuration. These authors stated that "The nutritional and toxicological consequences of D amino acids in the human diet are not well established." The racemization of aspartic acid and

PHE in aspartame may be of particular significance to heterozygous phenylketonurics (PKUs) , as well as to non-PKUs, since the components of some foods and beverages may also result in increased levels of D amino acids.

PHYSIOLOGICAL EFFECTS OF ASPARTAME

Unlike cyclamate and saccharin which are not metabolized in the human body and are excreted essentially unchanged in the urine, aspartame enters normal metabolic pathways (23). When ingested orally it is hydrolyzed in the intestinal lumen or mucosa to aspartate, phenylalanine, and . Aspinall, Saunders, Pautsch, and Nutting (5) 11

reported that aspartame, in excessive doses, did not have a significant effect on blood glucose levels, , or serum levels of , , and free fatty acids in laboratory rats. In a companion study, Bianchi,

Muir, Cook, and Nutting (8) investigated aspartame ingestion in relation to in rats. They reported that aspartame at doses of 250 mg/kg did not have a significant effect on food consumption, inhibition or secretion of gastric , the concentration of gastric acid, the proteolytic activity of pepsin, or the lipolytic activity of lipolytic lipase.

In response to concern about the effects of aspartame on infants, Filer, Baker, and Stegink (19) tested the plasma and erythrocyte free amino acid concentrations of one-year-old infants after aspartame loading at three different concentrations. At doses of 34 and 50 mg/kg body weight, no significant difference in aspartame metabolism was noted when compared to adults given equivalent doses.

Mean peak plasma PRE concentrations in infacts at 100 mg/kg body weight reached 22.3+11.5 umol/100 ml., with a similar rise in adult levels. Although the plasma PRE concentra­ tion noted was outside the usual postprandial range (12+3 umol/100 ml), it was far below the 120-300 umol/100 ml associated with toxic ~ffects.

Potts, Bloss, and Nutting (44) evaluated the effects of aspartame on the central nervous system in rodents.

Aspartame did not affect motor coordination, avoidance 12

learning, or pain response, but did result in a somewhat

higher activity level in the experimental group. Although

male rats had impaired learning behavior, it was

significant only in those fed a 9% aspartame diet for

thirteen weeks. This is the equivalent of approximately

550 times the expected consumption level for normal

individuals.

PROJECTED ASPARTAME INTAKES

Approval of aspartame by FDA commissioner Dr. Arthur

Hayes was granted because the evidence up to that point

indicated that aspartame would be safe even at the

"highest conceivable levels" of consumption (17). The FDA

has established the (ADI) for

aspartame at 50 mg/kg body weight (1). Actual consumption

can be projected by utilizing disappearance data for

sugar. It can be assumed th,at aspartame would replace the

apparent per capita sugar intake of 126.8 pounds per year

(11) or 156 g/day. Since aspartame is approximately 180

times sweeter than sucrose, the daily intake would be 876

mg/day. This figure assumes that aspartame could replace

sucrose in all sweetened products. It should be noted

that disappearance data overestimate consumption; therefore

actual aspartame intake would be somewhat lower (47).

Based on the molecular weight of the two moieties,

consumption of aspartic acid would contribute 347 mg and

PHE about 433 mg, with 87 mg of methanol as a by-product

~ 13

of metabolism.

PHENYLKETONURIA

One of the major concerns attributed to the

widespread use of aspartame is the effect of increased

amounts that may be consumed by heterozygous PKUs or

unrecognized PKUs. It has been noted in the literature

that unrecognized PKUs are rare (41), partly due to

postpartum infant diagnostic testing (24); however,

approximately one person in fifty is heterozygous for the

PKU gene (4,32). The question has been raised as to the

potential problems that may be encountered if these

individuals ingest the large amounts of aspartame

currently available in some 100 foods, beverages, and

medications (1).

Two studies by Stegink, Filer, Baker, and McDonnell

(58,59) addressed the issue of aspartame ingestion by

heterozygous PKU and normal adult subjects. The 1979 (58)

study tested the effects of aspartame loading (34 mg/kg

body weight in 300 ml of cold orange juice) on twenty

fasting individuals, eight of whom were heterozygous PKUs.

The heterozygous females were classified as such based on

the fact that each had given birth to at least one child

with classical phenylketonuria. The results indicated

that the erythrocyte aspartate levels were unchanged in

both groups. Peak plasma PRE levels were higher and the

plasma concentration-time curve was broader for the

t(' ·~~\

•• 14

heterozygous PKUs, yet well below those associated with

toxic effects.

In the following investigation (59) an abuse dose

(100 mg/kg body weight in 500 ml of cold orange juice) was

administered to eleven fasting subjects including five

female heterozygous PKUs. Evaluation of the data again

revealed higher mean peak plasma PHE levels and greater

area under the plasma concentration-time curve in

heterozygous PKUs, but still not to toxic levels. Lines

(32) commented on this study, pointing out that human cord

blood amino acid levels were higher than maternal blood

and higher PHE values might be a danger to the fetus of a

pregnant PKU heterozygote. He cited his study on rats

that showed the fetal:maternal ratio of PHE to be between

two and four and that fetal serum levels of PHE fell less

rapidly than those of the mother. In a rebuttal letter,

Stegink, Filer, Baker, and McDonnell (57) reported lower

fetal:maternal ratios of PHE and stated that the results

of the 1980 study were limited to a single abuse dose of

aspartame with short term plasma elevations. The authors

went on to comment that they had reported previously on

the potential risks of high use levels of aspartame by

pregnant PKU heterozygotes.

In general, it was recommended that pregnant women

limit the use of aspartame (1,23,42), since there is no way

to diagnose a PKU heterozygote until that person has a

child with classical PKU (71). If a woman with PKU . ~ 15

decides to have children, aspartame use should be omitted

and a low-PHE diet instituted before conception and

throughout the pregnancy. Low-PHE diets begun after

conception expose the fetus to increased risk (24).

The FDA has required the manufacturers of all

products that contain aspartame to have special labeling

that warns those with PKU that the product contains

pheylalanine (63,64). Wenz (69) believes the statement

"Phenylketonurics: contains Phenylalanine" is not

informative. She suggested that lables should include the

amount of aspartame by milligrams per serving or

percentage by weight. This change would enable PKUs and

to calculate the PHE values into the diet. At

present, this information is available only by request from the manufacturer of each food product (22) •

L-GLUTAMATE AND ASPARTAME

Perhaps the greatest controversy and the issue most

responsible for the revocation of the initial aspartame

approval involves L-glutamate. The chemical structure of

L-glutamate is similar to the aspartic acid moiety of

aspartame (23). The neurotoxicity of large doses,

primarily in the form of (MSG) , has

been documented in glutamate-sensitive individuals (55) •

Concern has been expressed for an additive effect that may

result in focal brain lesions in individuals who consume

MGS and/or aspartame. Several animal studies have f;, . l ' 16

documented brain lesions in the hypothalamic region induced by high doses of glutamate, aspartate (or aspartame), and other "neuroexcitatory" amino acids (39).

A study by Stegink, Filer, and Baker (56) with normal adults showed no significant increase in plasma glutamate or aspartate concentration after administration of high doses of MSG and aspartame with a high protein meal. A year earlier, a similar study was conducted with glutamate-sensitive individuals. The data indicated no effect on plasma aspartate levels, nor in any glutamate-type response (55). Based on these studies and other research, Commissioner Hayes of the FDA concluded that there is

a reasonable certainty that the proposed use of aspartame, either alone or together with glutamate, will not cause focal brain lesions in man or other adverse effects on the neuroendocrine system (64).

Daabees, Finkelstein, Stegink, and Applebaum (15) conducted a study on infant mice to determine the lowest dose of an aspartame/glutamate mixture that produced neurotoxic effects and also to determine the aspartame and glutamate plasma concentrations that were associated with those effects. Neonatal mice were selected as test animals since evidence indicated that they-~re highly sensitive to large doses of dicarboxylic amino acids (56) •

The study by Daabees et al. (15) confirmed earlier works in that neuronal necrosis did occur in three out of ten 17

mice given 500 mg/kg body weight glutamate; two out of 12

treated with 250 mg/kg of both glutamate and aspartate; and

in 25 out of 32 mice that were given 500 mg/kg each of

aspartate and glutamate. The individual threshold plasma

glutamate and aspartate concentrations associated with

neuronal necrosis were determined to be 75 umol/dl and 110

umol/dl respectively. It was concluded that 11 aspartame

ingestion at projected levels of intake, even when

ingested with glutamate, appears to pre~ent little, if

any, potential for neuronal necrosis in humans. 11 Olney

(38) stated that the safety of aspartame should not be

based on average consumption levels alone. Olney's

research has shown that a single elevation of blood

monosodium glutamate or monosodium aspartate above a

certain toxic threshold can destroy hypothalamic neurons.

METHANOL

The of aspartame yields approximately 10%

methanol. The toxicity of methanol to humans has long

been acknowledged (62). Commonly called the Methyl

Alcohol Syndrome, it occurs only in humans and no other

test animals (36) • There are few studies on methanol

toxicity and the severity can vary from one individual to

another (62). One theory suggested that the toxic effects

were due to the accumulation of and formic

acid during methanol metabolism (23). The rate of

methanol excretion was low and both metabolites of

. I ·a .... ~ 18

methanol oxidation were toxic; therefore, methanol was

considered a curnrnulative (36).

Tephly and McMartin (62) cited other information that

suggested that nutritional status of the individual may

have some effect on the degree of toxicity. Susceptibility

may depend on the activity of metabolic reactions that

require folic acid. Since folic acid plays an important

role in catalyzing the elimination of , the

folacin status of the individual may determine the degree

of methanol toxicity response (36). In a more general

sense, sound nutritional habits may result in better

hepatic capability to metabolize methanol and formate to

carbon dioxide for excretion (62).

The symptoms associated with methanol toxicity

include an initial of the central nervous

system followed by an asymptomatic latent period which

occurs 8-24 hours after ingestion (62). With chronic

exposure to methanol, gastrointestinal disturbances,

nausea, weakness, , vertigo, dizziness, memory

lapses, behavioral disturbances, neuritis, and ear buzzing

have been reported. Visual disturbances are the most

characteristic symptoms and can occur without acidosis.

Visual problems encountered are blurred vision, misty

vision, tunnel vision, and obscured vision (36) •

A question arose in regard to the impact that

increased amounts of methanol consumption, via aspartame,

may have on the average individual. According to the

~· 19

literature cited by Monte (36) the lethal dose of methanol

was 6 gm or the equivalent of 200 12 oz. cans of diet soda.

The "highest no-effect" level set in the Code of Federal

Regulations requires the margin of safety to be 100-fold

below that which may adversely affect sensitive or heavy

consumers of the substance in question. Based on this FDA

regulation the consumption of aspartame-sweetened beverages

should be limited to two 12 oz. servings per day: however,

the "highest no-effect" level has not been determined for

methanol.

Some authors have dismissed the importance of

increased methanol consumption associated with the use of

aspartame (4,23,50). Horowitz and Bauer-Nehrling (23)

cited research showing that blood and urine tests were

negative for formates after ingestion of aspartame at

levels as high as 200 mg/kg. In another study cited by

Sadler (50) , 100 mg/kg body weight of aspartame was

administered to adults and infants. Blood methanol levels

increased in both. The adults returned to pre-treatment levels eight hours after administration. The infants were

tested up to 2.5 hours, but projections indicated that

their levels would return to baseline in approximately the

same amount of time. Tephly and McMartin (62) noted that

while blood tests were useful in detecting methanol

toxicity, there was no correlation between blood methanol

levels and the Methyl Alcohol Syndrome since symptoms may

appear several hours after peak blood levels are t l, ~~;- 20

detected. The most recent study (16) found in the

literature on aspartame ingestion reported that consumption

of the FDA's estimated mean daily intake (6-8.7 mg/kg)

resulted in a temporary serum methanol increase which was

within the individual basal level range. It was concluded

that aspartame ingestion under normal circumstances would

come from consecutively spaced smaller doses. Therefore,

the small increase in serum methanol levels probably would

be undetectable and insignificant.

An article entitled "The continuing bitter-sweet

aspartame controversy" (14) pointed out that methanol is a

naturally occurring substance in many fruits and fruit

and that there is no proof that methanol from

aspartame metabolism poses any problem. For example, an 8

oz. portion of tomato juice contains 47 mg. of methanol

(2). Although methanol does appear in nature, the methyl

ester content is found in the pectin portion of fruits and

vegetables. The human digestive system does not contain

pectin esterase, the enzyme necessary to liberate free

methanol. In addition, high methanol intake from fruit

juices is unlikely since they have a high caloric density

and osmolarity which places limits on their consumption

level and rate (36). Even though the methanol content of

some aspartame-sweetened beverages may be lower than those

found in fruit juices (SO), individuals may consume

greater quantities of soft drinks because consumption is

not restricted by calories or osmolarity (36) • . tl ~&;; ~:, 21

DECOMPOSITION PRODUCT:

DIKETOPIPERAZINE

One of the final issues at question regarding the

safety of aspartame as a food additive was the possibility

of brain carcinogenicity induced by the decomposition of

aspartame to its diketopiperazine (DKP) form. The PBI

recommended that the approval of aspartame be withheld

_) until further testing by Searle ruled out the possibility

of a link between aspartame and brain tumors (52).

Commissioner Hayes disagreed with the PBI and stated that

the evidence submitted was sufficient to rule that a

significant risk of brain tumors was not demonstrated

( 64) •

One of the studies used by Searle to substantiate

earlier work on the carcinogenicity issue was done by

Ishii (25). Aspartame alone or in combination with DKP

was fed to 860 Wistar rats for 104 weeks. The author

stated that no significant difference in brain tumors was

noted between the control and treated groups. Although

this investigation was not entered as evidence for

Commissioner Hayes' decision, Hayes did state that it

served to "confirm the large body of evidence presented at

the hearing" (64) •

PSYCHOTOXICITY AND ASPARTAME

A short time before the FDA was to approve the use of ._,.

22

aspartame in soft drinks, opposition was raised by Richard

Wurtman, a neuroendocrinologist at Massachusettes

Institute of Technology {26) • Aspartame in small amounts

appeared to be safe, but his major concern was that

consumption levels could increase greatly once aspartame

was added to soft drinks. Wurtman {71) had conducted a

study of aspartame consumption in rats that showed changes

in brain amino acids and some suggesting

"neurochemical changes that could have functional or

behavioral consequences." Yokogoshi, Roberts, and

Caballero {73) participated in another study with Wurtman

that revealed increases in brain PHE and tyrosine levels

and reduced levels of the branched-chain amino acids

valine, leucine, and isoleucine. It is these amino acids

that compete with PHE and tyrosine for transport across

the blood brain barrier. When aspartame was consumed with

, the increase in serotonin levels that

normally follows glucose ingestion was blocked {7).

The consequences of these changes in brain amino

acids would most likely affect individuals with

hypertension, Parkinson's disease, insomnia, hyperkinesia,

or those taking monoamine oxidase inhibitor drugs that

interact with plasma tyrosine and PHE (71). A rise in

tyrosine levels could cause an increase in catecholamine

release from neurons and thus influence the physiological

and behavioral mechanisms that can lower certain types of

blood pressure. An early neurotoxicity study by Brunner, t

. . • '· 23

Vorhees, Kinney, and Butcher (10) revealed that rats fed a

6% aspartame or PHE diet had delayed eye opening, startle

response, forward locomotion, and swimming development.

Serotonin is involved with sleep onset and sensitivity to

certain types of pain (73).

As of October, 1984, aspartame had been investigated

and approved by health regrilatory agencies in 33 countries

and by the World Health Organization (14) • Sir Henry

Yellowlees, Chief Medical Officer for the Department of

Health and Social Security in London, and his staff,

reviewed the work by Wurtman and concluded that the

chemical changes reported by Wurtman were not unusual and

would be expected when any naturally occurring

PRE-containing food was consumed. Further, there was no

evidence that aspartame might cause adverse effects for

the proposed uses (72).

CONSUMER COMPLAINTS

Shortly after aspartame was approved for use in soft

drinks in July, 1983, the FDA received several complaints

about aspartame-containing products (31) • The FDA

requested assistance from the Centers for Disease Control

(CDC) to evaluate these complaints (67). _of the 592

complaints received by G.D. Searle, Dr. Woodrow C. Monte,

and Mr. James C. Turner the CDC interviewed 517

individuals. The demographics of this investigation

revealed that the complainants were predominantly Caucasian l 24

(96%), female (76%), and between the ages of 21-60 years

(79%) (45). Few of these people sought medical attention.

Sysmptoms reported were neurological/behavioral changes

(346); gastrointestinal disturbances (124); allergic or dermatological problems (76); and alterations in menstrual patterns (32). Some of those interviewed experienced problems in more than one category thus explaining why the total number of symptoms reported was higher than the actual number of individuals interviewed (67). A study by

Nehrling et al. (37) reported similar symptoms from subjects in their study; however only 20% in the aspartame group experienced adverse reactions in comparison to 40% in the placebo group.

Kulczycki (28) cited a case of aspartame induced urticaria (hives) that was confirmed by a double-blind challenge. The author suggested that this reaction may be due to DKP which is not normally found in the diet.

Another possible explanation was that antigenicity was induced by amide bonds that formed between aspartame or

DKP and endogenous . In response to the claim that aspartame may cause , Walter Glinsmann, M.D.,

Chief of Clinical at the FDA's Center for Food

Safety, responded that those who are prone to seizures could have them prompted by a variety of stimuli.

Examples included exposure to bright lights and loud noises or drinking too much liquid (51) •

For the most part, the CDC found that most of the ~~;

25

illnesses were mild and common in the general population

(45). Those who were critical of aspartame predicted that

the summer months of 1984 would lead to heavy

consumption and a large number of new complaints, but none

were reported (26). James Greene, a spokesman for the

FDA, acknowledged that there might be a small segment of

the population that was sensitive to aspartame and that

those who thought they were allergic could avoid aspartame

since all products are clearly labeled (45) •

WEIGHT CONTROL AND USE

OF ARTIFICIAL SWEETENERS

In the mid 1950's, McCann, Trulson, and Stulb (34)

studied the use of non-caloric sweeteners (saccharin and

cyclamate) and weight reduction. Their findings revealed

that approximately 43% of the obese subjects used

non-caloric sweeteners. A comparison between users and

non-users indicated no significant differences in weight

loss between the two groups. Rosenman (48) stated that

there is no evidence that artificial sweeteners were

useful in weight reduction. He cited a three year study

that showed no significant difference in artificial

sweetener use between those who lost weight and those who

gained or remained the same. The 1951 petition of Abbott

Laboratories for approval of cyclamate as a tabletop

sweetener recommended its use in the treatment of obese

individuals. Twenty years later when cyclamate was l ------~------

26

banned, the FDA stated that there was no substantial

evidence that cyclamate was effective in the treatment of

obesity (66). One of the most recent reports on

artificial sweetener use substantiated earlier studies in

that its use neither helped with weight loss nor prevented

weight gain (60).

In the Winter, 1985, issue of Newsweek's On Health

quarterly, Clark, Gosnell, Katz and Hager (11) did a

feature article on America's sweet tooth. It stated that

the "real cuprit" in obesity was not a craving for sugar

but an increased consumption of calorie-dense . This

article cited a study by Greenwood and Drewnowski that

showed that obese people preferred whipped cream with a

high content (34%) and a low sugar content (4%) while

non-obese individuals chose the 7.7% fat and 20.7% sucrose

combination.

On the positive side, McCann et al. (34) stated that

if only one person in four or five lost weight with the

aid of artificial sweeteners, and the product was

considered safe, it might have a place in the diet of some

obese individuals. Porikos and Van Itallie (43)

summarized one of their studies showing that subjects

stabilized their energy intake at 85% of baseline after 12

days when aspartame was substituted for sucrose in the

diet. Although this investigation was short term (15-30

days) and involved a small number of subjects (24) it was

suggested that low-calorie food analogues offered a new k~ I: I ~t

27

approach to dieting and should encourage compliance.

NON-CALORIE SWEETENERS

AND DIABETES MELLITUS

Farkas and Forbes (18) stated that many authors

believed frequent use of artificial sweeteners by

diabetics might stimulate or sustain a craving for sweets

.causing non-adherence to prescribed therapeutic diets.

McCann et al. (34) reported tht 71% of the obese

diabetics in their study said artificially sweetened

products were helpful to them in their diets. A select

committee of the American Diabetes Association published a

policy statement on saccharin after the proposed ban of

this substance by the FDA. After appraisal of the

experimental data, they stated that there was little

justification for placing governmental restrictions on

saccharin especially when the quality of life for many

individuals with diabetes had benefited from the

availability of this product (27). Nehrling et al. (37)

indicated that those with diabetes had welcomed aspartame

since it did not have the unpleasant aftertaste associated

with saccharin.

It is apparent from the literature that diabetics do

use artificial sweeteners. To test the effects of

aspartame on glycemic control, Nehrling et al. (37)

followed sixty-two subjects over a four month period. Both

fasting and postprandial plasma glucose values were

0 ' ~: ~. 28

unchanged in the 29 subjects administered aspartame. It

was concluded that aspartame did not adversely affect

glycemic control of persons with diabetes.

DENTAL CARIES AND

ARTIFICIAL SWEETENERS

Sucrose (table sugar) is known to cause dental caries

by reacting with bacteria in the mouth to produce acids

that attack tooth enamel (11). Rosenman (48) stated in

his review of artificial sweeteners that the cavity

potential of diluted sucrose in soft drinks was probably

less than that of sticky candy that can adhere to the

teeth. A regular soft drink was more cariogenic if taken

between meals than with meals. Those who chose

artificially sweetened soft drinks might still be at risk

due to the carboxylic acids. Studies in rodents indicate

that aspartame did not promote tooth decay (3) , but if

consumed in soft drinks, the carboxylic acids were still a

factor.

SENSORY EVALUATIONS OF

ARTIFICIAL SWEETENERS

In 1970, Cloninger and Baldwin (12) conducted a study

on aspartame that indicated it had the potential for use

as a low calorie sweetener in comparison with and in

combination with sucrose, cyclamate, and saccharin.

Aspartame did not differ significantly from sucrose in r~ l' 29

bitterness, aftertaste, off-, or general acceptance

in concentrations equivalent to sucrose. A later study by

these same researchers (13) indicated that the sweetening

potential of aspartame was enhanced by a non-carbonated,

orange flavored drink. Since this was a commercial orange

beverage mix, it was difficult to attribute the

enhancement to any specific ingredient.

Larson-Powers and Pangborn (29) compared sucrose to

aspartame, cyclamate, and saccharin for differences in

sensory properties. In orange drinks saccharin deviated

the most and those sweetened with aspartame deviated the

least from the reference. A test with fruit flavored

gelatins showed similar results.

A study was designed to determine if aspartame

affected the intensity of some fruit flavors (6).

Aspartame was found to intensify cherry and orange

flavored beverages, but it had no effect on strawberry

flavoring. These results were in contrast to those of

Larson-Powers and Pangborn (29) who noted a similar

response between strawberry and orange flavored drinks.

In gelatins of the same flavors no significant difference

was noted in intensity. Gelatin was believed to

depress the flavor intensity of products sweetened with

either sucrose or aspartame. The flavor intensification

capabilities of aspartame are specific for certain flavors

and only with some combinations of ingredients (23). ~ 30

One of the problems that has been encountered with

aspartame is that it can be used only in cool foods and

beverages. Subjects taste tested four sweeteners in tea at

room temperature. The data showed that sucrose was the

preferred sweetener and had the least aftertaste while

saccharin had the lowest scores for preference and

aftertaste. There was no significant difference between

fructose and aspartame in terms of acceptability; however

fructose was more costly to use than aspartame. The

authors speculated that if the test had been conducted in

a chilled beverage with a higher pH fructose might have

been rated higher (54) •

DEMAND FOR

ARTIFICIAL SWEETENERS

According to the scientific literature and product

sales data, the demand for a safe artificial sweetener is

evident. In 1984 the intake of artificial sweeteners was

15.8 sugar-equivalent pounds per person compared with 6.1

pounds in 1975 (11). The market for tabletop sweeteners

has doubled since aspartame was introduced (26).

According to a Nielson survey cited by Hannigan (21) use

of tabletop sweeteners that contain saccharin has not

dropped as much as might be expected. Two possible

reasons were given. First, aspartame attracted new users -

people who had used only sugar and those who did not like

the taste of saccharin. Secondly, aspartame was more

l. I .. ~ 31

expensive and this appeared to be a factor in switching from saccharin.

Jacobson (26) cited a beverage industry trade journal that predicted diet sodas would account for half of all carbonated soft drink sales by 1990. When aspartame sweetened soft drinks were first introduced, aspartame was blended with saccharin. According to Foltz and Hager (20), research by Searle indicated that seven out of ten diet­ soda drinkers did not like the blend. Searle insisted that all products contain 100% aspartame and offered a price incentive to manufacturers. Due to the popularity of aspartame, major soft drink bottlers have switched to 100% aspartame formulas despite higher manufacturing costs (21) •

It was estimated that the market for sugar and corn sweeteners would reach $7.15 million by 1994. Non­ nutritive sweetener sales were projected to be $785 million by the year 1995 (21) •

Due to obvious public demand, researchers have continued to search for a safe and acceptable non-nutritive sweetener. In the past there seemed to be no common molecular configuration or property that could be used to predict the sweetening capabilities of any substance (40).

More recent evidence cited by Raloff (46) has suggested that a substance must fit three receptor sites on the taste bud to taste sweet. In addition, the binding sites must be

a particular distance apart, oriented properly, and have 32

chemical groups that are the right size. For the time

being the solution might be to have a variety of

low-carlorie sweeteners available so that they can be used

in combination. The negative aspects of one sweetener might be compensated for by combining it with another

complementary sweetener (33). Lower concentrations of each

sweetener might result in a reduced potential for toxicity

(12). Since Searle will not allow aspartame to be used in

combination with any other artificial sweetener, the public

is forced to make a choice between saccharin and aspartame.

According to a recent review of artificial sweeteners

entitled "Sweeteners: Are any of them safe?" (61)

aspartame is the sweetener of choice on the issue of

safety. CHAPTER 3

PROCEDURE

In view of the controversy surrounding the artificial sweeteners currently in use, this study was conducted to identify respondents' perceptions of aspartame with regard to safety and acceptability with a limited comparison to saccharin and cyclamate. The dependent variable was the respondents' perception of aspartame. Extraneous variables included income and degree of consumer education or knowledge. A questionnaire was constructed for data collection that included questions on the following: the most important reason why the respondent used artificial sweeteners (1 question); saccharin use (1); aspartame use

(1); cyclamate (1); labeling (4); aftertaste (1); safety

(1); cost (1); sweetener preference (2); and identification of products used on a regular basis (1).

Six questions dealt with demographic information used to control extraneous variables such as income, educational status, and source of nutrition information. The total number of questions was, therefore, twenty.. See appendix page 56.

Male and female subjects were chosen on a non-random basis and on willingness to participate. The respondents were chosen by three criteria. These included regular use

33 34

of non-nutritive or artificial sweeteners, age of 16 or

more years, and residence within the Los Angeles

Metropolitan Area. The subjects were chosen from lower

division classes at California State University,

Northridge, employees of an amateur athletic foundation,

and acquaintances of the researcher. Explanatory

information regarding the questionnaire was given verbally

to each group or individual.

Data were collected at the nominal level of

measurement. The data were analyzed using descriptive

statistics including frequency counts, mode, and

percentages. Selected questions were tested for

statistical significance using chi square analysis and the

level of significance was set at 0.05.

. 0

-~------~~----:----~ - --~------______,____~------~ r

CHAPTER 4

RESULTS AND DISCUSSION

One hundrea and twent.y-two questionnaires were

distributed to determine the respondents' acceptance of

aspartame and aspartame-sweetened products and their

perception of its safety for consumption. The question-

naires were completed by students attending Calfornia State

University, Northridge, employees of an amateur athletic

foundation, and acquaintances of the researcher. One

questionnaire had to be discarded because of inappropriate

responses: therefore, the total number of respondents

included in the results of this study equaled one hundred

twenty-one. The questionnaire and raw data results are

presented in Appendix A.

DESCRIPTION OF THE SAMPLE

Thirty-six percent of the respondents were males. The

largest age group (76%) was 16-25 years of age probably due to the fact that the majority of the questionnaires were

distributed on a college campus. Single marital status

accounted for seventy-seven percent of the sample. Eighty-

eight percent of the subjects had attended college. Only

one hundred twelve subjects responded to the income

question. Of those, 28% lived in households with an income

of $50,000. and above. Twenty-seven percent had household

35 -----~------36 1 income of $10,000. or less. Each of the four remaining income categories was represented by an average of 10% of the sample responding to this question. Thirty-four of the respondents had taken a nutrition class or were currently enrolled in a course. The most frequent source of nutrition information was listed as magazines and newspapers. Table 1 shows a summary of the demographic data obtained in this study.

USE OF ARTIFICIAL SWEETENERS

The distribution of questionnaires was limited to those who reported that they regularly used artificial sweeteners and/or artificially sweetened products.

Therefore, 100% of the sample regularly used some type of artificial sweetener. Aspartame and saccharin are the two artificial sweeteners available in the United States.

Ninety-six percent of the sample had used both saccharin and aspartame. Cyclamate is currently being reviewed by the FDA for reapproval as an artificial sweetening agent.

When asked if they would try cyclamate if it were once again made available in the United States, 77% stated probably, 8% would definitely try it, and 15% definitely not. It was assumed that the older respondents might recall the controversy over cyclamate and be less inclined to try cyclamate in the future. Among those who would definitely not try cyclamate, no significant difference related to the age of the respondent was found.

- ---~--~------:------~~---~~-"----~------~-- 37

TABLE 1

DEMOGRAPHIC DATA

N %

Sex: Male 44 36 Female 77 64

Age: 16-25 92 76 26-35 10 8 36-45 8 7 46-55 8 7 over 55 3 2

Marital il Status: single 93 77 married 25 21 divorced 3 2

Educational

Status: some high school 2 2 i.:..: high school graduate 8 7 vocational school 1 1 some college 96 79 college graduate 11 9 advanced degree 3 2 other 0 0

Income: under $10,000 30 27 10,000-19,999 11 10 20,000-29,999 12 11 30,000-39,999 15 13 40,000-49,999 13 11 50,000 and above 31 28

Source(s) of Nutrition Information: Frequency magazines, newspapers 85 television 62 nutrition class 34 ~. 30 health food stores 21 sports publications 18 other* 17 nutritionist 7 registered 6

* family, books, radio, diet plans, product labels 38

PRODUCT WARNING LABELS

When any ingredient in a product marketed for consumption showed adverse effects in either human or animal studies; consumer warning labels regarding carcinogenic effects were required by the FDA. The effectiveness of these labels was investigated in relation to artificial sweeteners. Ninety-six percent of the subjects in this study reported that they had read the warning label on saccharin-containing products. Of those who had read the warning, only 37% stated that it had had a negative effect on their decision to use saccharin. On the other hand, only 38% had read the warning label on aspartame products about use by PKUs and 10% responded

that it had served as a deterrent.

The term phenylketonuric was not familiar to 94% of

the sample. Five of the seven subjects who did know this

term also responded that this term had significance to

them personally. This did not imply that they had PKU.

Two of the seven subjects were not sure if the term had

personal significance. All seven subjects had used

aspartame, but only one did not purchase products

containing aspartame on a regular basis.

PRODUCT SAFETY

Searle, the manufacturer of aspartame, promotes

aspartame by advertising that it is not an artificial

sweetener, but one that is made from natural proteins 39

commonly found in food (20). The question of safety is disputed by those who are concerned about the effects of high doses of aspartic acid and PHE that are released into the bloodstream when the individual consumes products such as soft drinks that have no other nutritional food value

(71). When aspartic acid and PHE are found in combination with other amino acids in foods, their digestion takes place more slowly (26) • Olney (38) pointed out that there is an important difference between ingesting a free amino acid and one that is bound in protein.

On the issue of safety, 41% believed that neither saccharin nor aspartame was safe to consume although they did use products containing saccharin and/or aspartame.

Seven percent reponded that both were safe. Aspartame was chosen as the safer product by 45% of the sample compared to 7% who chose saccharin.

TASTE ACCEPTABILITY

The subjects were asked one question about taste acceptability and two regarding product preference.

Fifty-seven percent of the sample thought that saccharin had an aftertaste. Another study on sugar and artificial sweetener acceptance in tea also rated saccharin as having the most unpleasant aftertaste of the sweeteners tested

(54) • Only 5% of the subjects in this present study checked that aspartame had an aftertaste. No aftertaste was noted in either product by 20% of the sample. The 40

remaining eighteen percent thought that both aspartame and saccharin elicited an aftertaste.

When given a choice between two identical products except for the fact that one was sweetened with aspartame and the other with sugar, aspartame was chosen as the preferred sweetener. Marketing information on aspartame­ based presweetened products reported similar findings in that product sales grew slightly more than one-third in

1985 over the previous year. Sugar-sweetened product sales declined, indicating a consumer preference for aspartame­ containing products (21). When the subjects had to choose between aspartame- and saccharin-sweetened products, aspartame again was the preferred sweetener. The results were significant (0.05 level) for both questions regarding preference.

COST

Since cost is a factor when purchasing an artificial sweetener, the subjects were asked if the higher cost of aspartame had any influence on their decision to purchase artificial sweetener packets (Equal). Twenty-six percent responded that the increased cost was a negative factor, but 48% stated that cost was not a factor £or concern.

Hannigan (21) noted increased sales for aspartame­ sweetened products and stated that "customers know what they want and are willing to pay for it." Neither high nor low income levels predominated in either group. Twenty- 41

six percent did not purchase aspartame in packets.

REGULAR USE OF

ASPARTAME PRODUCTS

The subjects were asked to identify the types of

aspartame-sweetened products they used on a regular basis.

A list of products was provided for the subjects'

selection. Carbonated soft drinks were the most frequently

used products followed by chewing gum. The remaining

products, in descending order of frequency, were Equal

packets, non-carbonated drink mixes, dessert mixes

(gelatin, pudding, whipped topping), breakfast cereals,

and flavored . Products such as instant tea

and mints were listed by the respondents in the category

designated as other (Table 2).

The subjects in this study indicated that they

regularly used an average of 2.3 products sweetened with

aspartame. Since the approval of aspartame, the FDA has

continued to expand the list of new product categories in

which aspartame may be used. Under consideration are

orange juice, , and (20). As more and

more products containing aspartame are approved,

consumption levels might reach or exceed the ADI of - SOmg/kg body weight. The FDA has required Searle to

monitor consumption levels of aspartame and this product

"may be marketed so long as the projected consumption

levels fall sufficiently below the toxic threshold" (64).

' v 42

To comply with this FDA requirement, Searle has contracted

Market Research Corporation of America to survey aspartame users and calculate their levels of consumption. As of 1985, the data showed that aspartame consumption was well within the FDA limits for all age groups (61).

TABLE 2 REGULAR USE OF ASPARTAME PRODUCTS

PRODUCT TYPE FREQUENCY

N

Carbonated soft drinks 95 Chewing gum 82 Equal packets 35 Non-carbonated drink mixes 31 Packaged dessert mixes e.g. puddings, gelatin 29 Breakfast cereals 27 Flavored instant coffee 10 I do not purchase products with aspartame 7 Other * 6 * Iced tea mix, mints

REASONS FOR ARTIFICIAL SWEETENER USE There was a significant difference in the reasons why

the subjects in this study used artificial sweeteners.

Fifty-two percent responded that they used them to reduce

caloric intake. No conclusive studies have demonstrated that the use of artificial sweeteners contributes

significantly to weight loss. Porikos and Van Itallie 43

(43) studied the efficacy of aspartame on weight loss.

These researchers concluded that there was no physiological need to replace the calorie reduction provided by aspartame substitution in the diet; however, limitations were placed on the study since the psychological issues of food intake were not addressed.

They stated that those who used artificial sweeteners to reduce caloric intake might use this as an excuse to increase consumption of other high calorie foods. McCann et al. (34) found no relationship between consumption of artificial sweeteners and weight loss. Horowitz and

Bauer-Nehrling (23) cited a study in which there was no significant difference in the amount of weight loss between adolescents who used aspartame and those who did not in a weight reduction program. Research on the role of artificial sweeteners and weight maintenance was not noted in the literature.

Twenty-eight percent of the subjects stated that they used artificial sweeteners to reduce overall sugar intake.

Although there is no harm in moderate sugar consumption for healthy individuals, sugar has been associated with obesity, heart disease, allergic reactions, hyperactivity, and even violent crime (Clark et al., 1985). The respondents were not asked why they wanted to reduce their

sugar consumption.

Eleven percent of the subjects stated that they used artificial sweeteners because they preferred the taste. 44

There was a significantly greater number of females than males who preferred the taste of artificial sweeteners. It was assumed that those who preferred the taste of artificial sweeteners might use more aspartame products on a regular basis. This group averaged 2.6 products and the sample as a whole was much the same averaging 2.3 products.

Six percent of the sample had reasons other than those

listed. These answers included: 1) not aware that the product contained an artificial sweetener, 2) do not like

sugar, 3) because its there, and 4) try to avoid them, but do use artificial sweeteners.

Only three percent of the sample reported that they used artificial sweeteners to prevent dental caries. It has been established that sugar consumption does contribute

to cavity formation, but is was not an important reason to

the subjects in this study. Rosenman (48) stated that

dental caries occured most commonly between the

ages of 15 and 24 years. Seventy-six percent of the

respondents in this study were between the ages of 16-25,

yet only three percent were concerned about dental

cavities.

Only one female stated that she used artificial

sweeteners for medical reasons. More specif~c information

was not requested in the questionnaire. Those with

diabetes mellitus must restrict their intake of sugar and

it was believed that artificial sweeteners might be of 45

benefit in following the restrictions of their prescribed diets. Farkes and Forbes (18) found that the use of artificial sweeteners did not affect adherence to carbo­ hydrate restricted diets in women with diabetes.

According to Horowitz and Bauer-Nehrling (23) the real benefit may have something to do with psychological needs rather than dietary. This would be especially true with children since sweets are frequently a part of social functions.

The difference between male and female responses and artificial sweetener use was investigated in this study. Forty percent of the men used artificial sweeteners to reduce sugar intake. This response was given by only 21% of the women. The most frequent response by females was to reduce caloric intake (61%). Caloric reduction was listed as most important by 37% of the men. Similar results were obtained for both male and female subjects with regard to use of aritificial sweeteners for the prevention of dental caries and for medical reasons. CHAPTER 5

SUMMARY, CONCLUSIONS AND RECOMMENDATIONS

In September of 1986, a study was conducted to deter­ mine the respondents acceptance of aspartame and their perception of its safety for consumption. A questionnaire was used as the data collection instrument. The one hundred twenty-one subjects who participated in this study were students at California State University, Northridge, employees of an amateur athletic association, or acquaintances of the researcher.

Statistical testing by chi-square (0.05) showed that there was a significant difference in preference for

artificial sweeteners. Fifty-nine percent of the subjects

preferred aspartame to sugar and 71% preferred aspartame

to saccharin. More women than men used artificial

sweeteners because they preferred the taste to that of

sugar. These results were statistically significant

(0.05).

Forty-five percent of the sample believed that

aspartame was safer than saccharin to consume. Forty-one

percent believed that neither was safe but used aspartame­

and/or saccharin-sweetened products on a regular basis.

There was a significant difference (0.05) in the

reasons why this sample used artificial sweeteners when

46 47

tested by chi-square. Most of the respondents used these products to reduce caloric consumption. When separated into male and female resonses, men were found to be more likely to use artificial sweeteners to reduce overall sugar intake and women to reduce caloric intake.

There was no significant difference (0.05) in age among those who stated that they would not try cyclamate if it were once again made available. The majority of sub­ jects stated that they would probably try cyclamate and a few would definitely try it.

Almost all of the respondents had read the warning label on saccharin products and nearly two-thirds stated that it would not deter them from using saccharin. Thirty­ eight percent of the sample had read the warning about PKU on aspartame products. Of those, only 21% stated that it served as a deterrent to their use of the product.

The majority (94%) were not familiar with the term phenylketonuric. This same percentage either did not know or were not sure if this term had any significance for them.

The increased cost of artificial sweetener packets

(Equal) was not an important consideration for about one-half of the sample. Income level did not appear to affect their decision to purchase the more expensive product since all income groups were equally represented among those who used aspartame. About one-fourth of the 48

subjects did not purchase artificial sweetener packets.

The most frequently used artifically-sweetened product

was soft drinks, followed by chewing gum. Respondents used

an average of 2.3 artifically-sweetened products on a

regular basis.

RECOMMENDATIONS FOR FURTHER STUDY

Results of this study have prompted the following

recommendations:

1) Conduct a similar study with a greater

distribution of subjects in upper age groups.

2) Further study to determine why respondents

perceive one artificial sweetener to be safer than

another.

3) More studies on the role of artificial

sweeteners in therapeutic diets, weight loss, and weight

maintenance.

' 6

_I ______....______------~----~------~--~------~ ~--- -·-- REFERENCES

1. "A Healthy Perspective on Aspartame ... Tufts University Diet and Nutrition Letter 3, no. 7 (1985): 1-2. 2. "Aspartame ... Editorial. American Family Physician 20, no. 6 (1979): 69-70.

3. "Aspartame and Other Sweeteners... The Medical Letter on Drugs and Theraputics 24, no. 600 (1982): 1-2.

4. "Aspartame Off the Hook? 11 Tufts University Diet and Nutrition Letter 2, no. 10 (1984): 1.

5. Aspinall, Richard L.; Saunders, Robert N.; Pautsch, Walter F.; and Nutting, Ehard F. 11 The Biological Properties of Aspartame: v. Effects on a Variety of Physiological Parameters Related to Inflammation and Metabolism." Journal of Environmental and Toxicology 3, no. 5-6 (1980): 387-95.

6. Baldwin, Ruth E. and Korschgen, Bernice M. 11 Intensification of Fruit Flavors by Aspartame ... Journal of 44, no. 3 (1979): 938-9.

7. Beardsley, Tim. 11 Sour Welcome for Aspartame." Nature 305 (September 15, 1983): 175.

8. Bianchi, Robert G.; Muir, Esther T.; Cook, Donald L.; and Nutting, Ehard F. "The Biological Properties of Aspartame: II. Actions Involving the Gastrointestinal Systems." Journal of Environmental Pathology and Toxicology 3, no. 5-6 (1980): 355-62.

9. Boehm, Marcus F. and Bada, Jeffrey L. 11 Racemization of aspartic acid and phenylalanine in the sweetener aspartame at 100 C." Proceedings of the National Academy of Science USA. 81, (August, 1984) : 5263-5266.

10. Brunner, Robert L.; Vorhees, C.V.; Kinney, L.; and Butcher, R.E. "Aspartame: Assessment of Developmental Psychotoxicity of New Artificial Sweetener." Neurobehavioral Toxicology 1, no. 1, (1979): 79-86.

49 50

11. Clark, Matt; Gosnell, Mariana; Katz, Susan; and Hager, Mary, "Sugar and its Substitutes: Are we Getting Sick on Sweets." Newsweek On Health, Winter, 1985, pp. 6-9.

12. Cloninger, Marion R. and Baldwin, Ruth E. "Aspartylphenylalanine Methyl Ester: A Low-Carlorie Sweetener." Science 170, (October, 1970): 81-2.

13. ------. "L-aspartyl-L-Phenylalanine Methyl Ester (Aspartame) as a Sweetener." 39, (March-April, 1974): 347-349. 14. "The continuing bitter-sweet aspartame controversy." Tufts University Diet and Nutrition Letter 2, no. 8, (1984): 5-6.

15. Daabees, T.T.; Finkelstein, M.W.; Stegink, L.D.; and Applebaum, A.E. "Correlation of Gluatamate Plus Aspartate Dose, Plasma Amino Acid Concentration and Neuronal Necrosis in Infact Mice." Food and Toxicology 23, no. 10 (198sr:- 887-893.

16. Davoli, E.; Cappellini, L.; Airoldi, L.; and Fanelli, R. "Serum Methanol Concentrations in Rats and in Men After a Single Dose of Aspartame." Food and Chemical Toxicology 24, no. 3 (1986): 187-189.

17. Dickson, David, "Aspartame - New Court Overruled." Nature 292, (July 23, 1981): 283.

18. Farkas, Carol Spindell and Forbes, Clare E., "Do Non-Caloric Sweeteners Aid Patients with Diabetes to Adhere to Their Diets." Journal of the American Dietetic Association 46, no. 6, (1965): 482-484.

19. Filer Jr., L.J.; Baker, G.L.; and Stegink, Lewis D. "Effect of Aspartame Loading on Plasma and Erythrocyte Free Amino Acid Concentrations in One-Year-Old Infants." Journal of Nutrition 113 no. 8, (1983): 1591-1599.

20. Foltz, Kim and Hager, Mary, "Sweet-Talking the Public." Newsweek, 28 January 1985, p.57.

21. Hannigan, Kevin, "New Products Analysis." , 57 (October, 1985): pp. 65-88. 51

22. Horowitz, David L. and Bauer-Nehrling, Jeanine. Letter. Journal of the American Dietetic Association 8 4, no. 1 (19 8 4) : 101-2.

23. ------. "Can Aspartame Meet Our Expectations?" Journal of the American Dietetic Association 83, no. 2 (1983): 142-6.

24. Hunt, Melanie M.; Berry, Helen K.; and White, Pamela P. "Phenylketonuria, adolescence, and diet." Journal of the American Dietetic Association 85, no. 10 ( 19 8 5) : 13 2 8-4 4. 25. Ishii, Hiroyuki. "Incidence of Brain Tumors in Rats Fed Aspartame." Toxicology Letters 7, no. 6 (1981): 433-7. 26. Jacobson, Michael F. Complete Eater's Digest and Nutrition Scoreboard. Garden City, N.Y.: Anchor Press, 1985.

27. Kalkhoff, Ronald K.; Brunzell, John A.; Davidson, John A.; Gebhardt, Margaret; Knowles, Harvey C.; Levin, Marvin E.; Poucher, Russell L.; and Wake, Madeline; "Policy Statement: Saccharin." Diabetes 27, no. 8, (1978): 878-879.

28. Kulcycki, Anthony. "Aspartame-Induced Urticaria." Annals of Internal 104, no. 2 (1986): 207-8.

29. Larson-Powers, Nancy and Pangborn, Rose Marie. "Descriptive Analysis of the Sensory Properties of Beverages and Gelatins Containing Sucrose or Synthetic Sweeteners." Journal of Food Science 43, no. 11 (1978): 47-51. 30. Lecos, Chris w. "The Sweet and Sour History of Saccharin, Cyclamate, Aspartame." FDA Consumer, U.S. Department of Health and Human Services Publication No. 81-2156. Rockville, MD.: Service. September, 1981.

31. ------. "Sweetness Minus Calories-Controversy." FDA Consumer, U.S. Department of .Health and Human Services Publication No. 85-2205. Rockvill, MD.: Public Health Service. February, 1985.

32. Lines, David R. Letter. Journal of Nutrition 111, no. 9 (1981) : 1688. 52

33. Lukasick, Jeanne. "A New Era in Sweetness." Beverage World, April, 1986, pp. 26-8, 87-9. 34. McCann, Mary B.; Trulson, Martha F.; and Stulb, Sarah C. "Non-Caloric Sweeteners and Weight Reduction." Journal of the American Dietetic Association 32, no. 4 (1956): 327-30.

35. Mazur, Robert H. "Discovery of Aspartame." In Aspartame: and , Ed. Lewis D. Stegink and L.J. Filer. New York: Marcel Dekker, Inc., 1984.

36. Monte, Woodrow C. "Aspartame: Methanol and the Public Health." Journal of Applied Nutrition 36, no. 1, ( 19 8 4) : 4 2-5 4 • 37. Nehrling, Jeanine Kullessa; Kobe, Peter;_McLane, Michael P.; Olson, Ronald E.; Kamath, .· Savitri; Horowitz, David L.; "Aspartame Use by Persons with Diabetes." Diabetes Care 8, no. 5, (1985): 415-417.

['""'-} c ,_··.' . ~ ~ '· .-, . 38. Olney, John w. Letter. "L-Glutamic and L-Aspartic Acids-A Question of Hazard?" Food and Cosmetics Toxicology 13, (1975) : 595-6. · • -·

39. Olney, John; Ho, Oi Lan; and Rhee, Vasela. "Brain-Damaging Potential of Protein· 11 Hydrolysates. . New England Journal of Medicine 2 8 9 , no. 8 (.19 7 3) : 3 91-3 9 5 •

40. Parker, K.J. "Alternatives to Sugar." Nature 271, no. 5645 (1978): 493-5.

41. Perry, Thomas L.; Hansen, Shirley; Tischler, Bluma; Richards, Frances; and Sokol, Marlene. "Unrecognized Adult Phenylketonuria." New England Journal of Medicine 289, no. 8 (1973) : 395-8.

42. Peterson, Shirley. "Pros and Cons on Aspartame." Ventura County Star Free Press. Sect. B, p. 4, cols. 1-2, 4 September 1985.

43. Porikos, Katherine P. and Van Itallie, Theodore P. "Efficacy of Low-Calorie Sweeteners in Reducing Food Intake: Studies with Aspartame." In Aspartame: Physiology and Biochemistry~ :',Ed. Lewis D. Stegink and L.J. Filer Jr~- New York:· Marcel Dekker,rinc., 1984. I I I ··-·--- - ·------···------~J 53

44. Potts, W. Joseph; Bloss, James L.; and Nutting, E.F. "Biological Properties of Aspartame: I. Evaluation of Central Nervous System Effects." Journal of Environmental Pathology and Toxicology 3, no. 5-6 (1980): 341-353. 45. Puzo, Daniel. "New Study Sees No Aspartame Problem." Los Angeles Times, 8 November 1984, sec. 8, p. 45, cols. 1 -3. 46. Raloff, J. "A sweet taste of success to drink in." Science News 27, no. 5 (1985) : 262.

47. Roak-Foltz, Roberta, and Leveille, Gilbert. "Projected Aspartame Intake: Daily Ingestion of Aspartic Acid, Phenylalanine, and Methanol." In Aspartame: Physiology and Biochemistry. Ed. Lewis D. Stegink and L.J. Filer Jr. New York: Marcel Dekker, Inc.,. 1984.

48. Rosenman, KennethC'z"Benefits of Saccharin: A Review." Environmental Research 15, (1978): 70-81.

~· .~ ·"· :... -·-~ r :, .. :· -- ~ , ·~, 11 49. "Saccharin. -·, Journal, of the American Dietetic Association•74, no~-1 (1979): 68.

50. Sadler,.M~J. "Recent Aspartame Studies." ·and Toxicology 22,.no. 9 (1984): 771-773.

51. "Safety of aspartame upheld again." Tufts University Diet and Nutrition Letter. 4, no. 4 (1986): 2. 52. Smith, R. Jeffrey. "Aspartame Approved Despite Risks." Science 213, (28 August 1981): 986-7.

53. ------. "Latest Saccharin Tests Kill FDA Proposal." Science 208, (11 April 1980): 154-6.'

54. Sprowl, Diane J. and Ehricke, Lou A._ "Sweeteners: Consumer acceptance in tea." Journal of the American Dietetic Association 84, no. 9 (1984): 1020-2. --- 55. Stegink, Lewis D.; Filer Jr., L.J.; and Baker, George L. "Effect of aspartame and sucrose loading in glutamate-susceptible subjects." American Journal of 34, no. 9 (1981): 1899-1905. l--~------~------~------___1 54

1

56. ------. "Effect of aspartame plus monosodium L-glutamate ingestion on plasma and erythrocyte amino acid levels in normal adult subjects fed a high protein meal. American Journal of Clinical Nutrition 36, no. 6 (1982): 1145-52.

57. Stegink, Lewis D.; Filer L.J.; Baker, George L.; and McDonnell, J.E. Letter. Journal of Nutrition 111 , no • 7 , (19 81) : i 6 8 8-9 •

58. ------. "Effect of Aspartame Loading upon Plasma and Erythrocyte Amino Acid Levels in Phenylketonuric Heterozygotes and Normal Adult Subjects." Journal of Nutrition 109, no. 4 (1979): 708-717.

59. ------. "Effect of an Abuse Dose of Aspartame , upon Plasma and Erythrocyte Levels of Amino Acidsi in Phenylketonuric Heterozygous and Normal l Adults." Journal of Nutrition 110, no. 11 ( 1980) : 2216-2224.

60. Stellman, Sven D• and Garfinkel, Lawrence. "Artificial Sweetener Use and One-Year Weight Change Among Women." Preventive Medicine. 15, no. 2 (1986): 195-201.

61. "Sweeteners: Are any of them safe?" Consumer Reports, November 1985, 690-3.

62. Tephly, Thomas R. and McMartin, Kenneth E. "Methanol Metabolism and Toxicity." Aspartame: Physiology and Biochemistry. Ed. Lewis D. Stegink and L.J. Filer, New York: Marcel Dekker, Inc., 1984. 63. u.s. Department of Health and Human Services. "Aspartame." Code of Federal Regulations. 172.804, Revised as of April 1, 1986.

64. ------. "Aspartame: Commissioner's Final Decision." Federal Register. 46, no. 142 (24 July 1981): 38284-38308.

65. ------. "Aspartame: Rulings on Objections and Notice of Hearing Before a Public Board of Inquiry. Federal Register. 44, no. 107 (1 June 1979): 31716-31718. '

66. ------. "Cyclamate: Commissioner's Decision." I Federal Register. 45, no. 181, (16 September j 1980): 61474-7. '------·-·------··------·------···· 55

67. ------. "Evaluation of Consumer Complaints Related to Aspartame Use." Centers for Disease Control Morbidity and Mortality Weekly Report. 33, no. 43 (1984): 605-7. 68. Vandervoort, Kay. "Sweeteners for the sweet-but which one is safe?" Daily News (Los Angeles). Food Sect., p. 24, cols. 1-4, p. 36, col. 1, 26 September 1985.

69. Wenz, Elizabeth, Letter. "Aspartame and PKU." Journal of the American Dietetic Association 84, no • 1 , ( 19 8 4) : 1 0 1 •

70. Whitney, Eleanor Ross and Cataldo, Corrinne Balog. : Understanding Normal and Clinical Nutrition. Paul: West, 1983.

71. Wurtman, Richard J. Letter. New England Journal of Medicine 309, no. 7 (1983): 429-430.

72. Yellowless, Henry. Letter. British Medical Journal 287, (24 September 1983): 912-3. 1 I 73. Yokogoshi, Hidehiko; Roberts, Carolyn H.; Caballero, 1 Benjamin; and Wurtman, Richard J. "Effects of · aspartame and glucose administration on brain andl plasma levels of large neutral amino acids and I brain 5-hydroxyindoles." American Journal of 1 Clinical Nutrition 40, (July, 1984): 1-7. I

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QUESTIONNAIRE

Directions: Please place a check mark (~) in the space provided for each question. Choose the answer that best describes your opinion on each topic.

1. What is the most important reason why you use artificial sweeteners? '

33 To reduce overall sugar intake. .275 3 To prevent dental cavities. .025 63 To reduce calorie intake. .525 13 Prefer the taste. .108 1 Medical reason e.g. Diabetes .008 7 Other (Please specify) ______.058

2. Do you ever or have you ever used products that contain saccharin?

116 Yes .958 5 No .041

3. Have you ever read the warning label on products that contain saccharin?

99 Yes .818 22 No .182

If YES, would the warning label deter you from buying or using saccharin?

37 Yes .374 62 No .626

4. Do you ever or have you ever used products that contain aspartame (Nutra-Sweet, Equal)?

116 Yes .959 5 No .041

'1, -- ______j 58

5. Have you ever,read the warning.label on products that contain aspartame?

76 Yes .380 75 No .620 If yes, would the warning lable deter you from buying or using aspartame?

10 Yes .217 36 No .783

6. The warning label on products sweetened with aspartame: is directed at Phynylketonurics. Are you familiar i with this term?

7 Yes .058 114 No .~- . .942

•·' 7. Do you know if this term has any significance for you?[

7 Yes .059 w- No .411 ~ Not sure .530

8. Which artificial sweetener do you think is safer to use?

54 aspartame .450 8 saccharin .067 8 both .067 50 neither .416

9. Which artificial sweetener do you think has an aftertaste?

6 aspartame .050 68 saccharin .567 22 both .183 24 neither .200 i l i !

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10. If:you had'the chance to purchase two identical pro­ ducts except--for the fact that one contained sugar and the other aspartame, which product would you most likely purchase?

49 product sweetened with sugar .408 71 product sweetened with aspartame .592

11. If you had the chance to purchase two identical products except for the fact that one contained aspartame and the other saccharin, which product would you most likely purchase?

84 product sweetened with aspartame .712 34 product sweetened with saccharin .288 : ~: ..

12. Aspartame,packets (Equal) are approximately three times as costly as saccarin packets (Sugar Twin, Sweet and Low). Would the increased cost deter you from purchasing aspartame packets? 31 Yesq ,-., .256 58 No:;:_c- .479 32 I'do.not purchase artificial sweetener packets .264

13. If you purchase products that contain aspartame, please indicated which types of products you use on a regular basis. Check as many as apply. :, L•J~'~\ r· 95 Carbonated soft drinks 1 31 Non~carbonated:drink mixes 4 82 Chewing:gum 2 29 Packaged dessert mixes e.g. gelatin, pudding 1' whipped topping 5 35 Equal packets 3 27 Breakfast cereals 6 10 Flavored instant coffee 7 6 Other (Please specify) __~--~~------~­ 9 7 ! do not purchase products with aspartame 8

14. Cyclamate is an artifical sweetener presently not available in the United States. If it is once again made available would you ••• ·- 10 definitely try it • 084 ' ~n probably try it • 765 i 18 definitely not try it .151 I .__ j 60

· PERSONAL DATA: The following questions will help categorize the information you have provided above. All answers will be kept confidential and are for statistical purposes only.

15. Sex:

44 Male .364 77 Female .636

16. Age:

92 16-25 .760 10 26-35 .082 8 36-45 .066 8 46-55 .066 3 over 55 .024

17. Marital Status:

93 Single .768 g- Married .207 -3- Divorced .025 Widowed Separated

18. Educational Status:

2 some high school .0166 a- high school graduate .066 -1- vocational school .008 gr- some college .793 rr- college graduate .091 -3- advanced degree .024 other (Please specify)

19. Income (Household)

30 under $10,000. .268 11 10,000 - 19,999 .098 12 20,000 - 29,999 .107 15 30,000 - 39,999 .134 13 40,000 - 49,999 .116 31 50,000 and above .276

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20. From what source(s) do you receive most of your nutri­ tion information? Check as many as apply.

34 nutrition class 3 85 magazines, newspapers 1 62 television 2 18 sports publications 6 21 health food stores 5 30 physician 4 6 registered dietitian 9 7 nutritionist 8 17 other (Please specify) ______7

Thank you for taking the time to complete this question­ naire. Your cooperation is greatly appreciated.

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PREFERENCE: SUGAR VS. ASPARTAME

Prefer Prefer Sugar Aspartame TOTAL

2::. i \ Observed frequencies {0) 49 71 120 Expected frequencies (E) 60 .·: 60 120 Difference -11 11 Difference squared 121 121

Difference squared/(E) 2.01 2.01

Chi-square - 4.02 Criterion value 0.05 - 3.841 ~­ Data are significant

PREFERENCE: ASPARTAME VS. SACCHARIN

Prefer Prefer Aspartame Saccharin TOTAL

Observed frequencies (0) 84 34 118 Expected frequencies (E) 59 59 118 Difference 25 -25 Difference squared 625 625 Difference squared/(E) 10.59 10.59

Chi-square - 21.18 Criterion value 0.05 - 3.841 i Data are significant

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REASONS FOR USE OF ARTIFICIAL SWEETENERS

1 2 3 4 5 6 TOTAL

iObserved (0) 33 3 63 13 1 7 120 !Expected (E) 20 20 20 20 20 20 120 !Difference 13 -17 43 -7 -19 -13 ·;Difference squared 169 289 1849 49 361 169 \Difference squared i (E) 8.45 14.45 92.45 2.45 18.05 8.45 I ------~------~------\chi-square - 144.3 !Criterion value 0.05 - 11.070 IData are significant

I MALE VS. FEMAJ...E PREFER TASTE OF ARTIFICIAL SWEETENERS

Male Female TOTAL

!Observed (0) 2 11 13 !Expected (E) 6.5 6.5 13 'Difference -4.5 4.5 ,Difference squared 20.25 20.25 i Difference squared/(E) 3.11 3.11

~hi-square - 6.22 ~riterion value 0.05 - 3.841 .Data are significant

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