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A Dietary Supplement Containing Standardized Phaseolus Vulgaris Extract Influences Body Composition of Overweight Men and Women

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A Dietary Supplement Containing Standardized Phaseolus Vulgaris Extract Influences Body Composition of Overweight Men and Women Int. J. Med. Sci. 2007, 4 45 International Journal of Medical Sciences ISSN 1449-1907 www.medsci.org 2007 4(1):45-52 © Ivyspring International Publisher. All rights reserved Research Paper A Dietary Supplement Containing Standardized Phaseolus vulgaris Extract Influences Body Composition of Overweight Men and Women Leonardo Celleno 1, Maria Vittoria Tolaini 1, Alessandra D’Amore 1, Nicholas V. Perricone 2, Harry G. Preuss 3 1. Cosmetic Research Center, dell’Università Cattolica di Roma, Rome, Italy 2. NV Perricone, MD, Ltd, Meriden, CT 06450, USA 3. Georgetown University Medical Center, Department of Physiology, Washington, DC 20057, USA Correspondence to: Harry G. Preuss MD, Professor of Physiology, Medicine, & Pathology, Basic Science Building, Room 231B, Georgetown University Medical Center, Washington, DC 20057. [email protected] Received: 2006.12.13; Accepted: 2007.01.23; Published: 2007.01.24 Background: More than one billion human adults worldwide are overweight and, therefore, are at higher risk of developing cardiovascular diseases, diabetes, and a variety of other chronic perturbations. Many believe that use of natural dietary supplements could aid in the struggle against obesity. So-called "starch blockers" are listed among natural weight loss supplements. Theoretically, they may promote weight loss by interfering with the breakdown of complex carbohydrates thereby reducing, or at least slowing, the digestive availability of carbo- hydrate-derived calories and/or by providing resistant starches to the lower gastrointestinal tract. Aims: The present research study examines a dietary supplement containing 445 mg of Phaseolus vulgaris extract derived from the white kidney bean, previously shown to inhibit the activity of the digestive enzyme alpha amylase, on body composition of overweight human subjects. Methods: A randomized, double-blinded, placebo-controlled study was conducted on 60 pre-selected, slightly overweight volunteers, whose weight had been essentially stable for at least six months. The volunteers were divided into two groups, homogeneous for age, gender, and body weight. The test product containing Phaseolus vulgaris extract and the placebo were taken one tablet per day for 30 consecutive days before a main meal rich in carbohydrates. Each subject’s body weight, fat and non-fat mass, skin fold thickness, and waist/hip/thigh cir- cumferences were measured. Results: After 30 days, subjects receiving Phaseolus vulgaris extract with a carbohydrate-rich, 2000- to 2200-calorie diet had significantly (p<0.001) greater reduction of body weight, BMI, fat mass, adipose tissue thickness, and waist,/hip/ thigh circumferences while maintaining lean body mass compared to subjects receiving placebo. Conclusion: The results indicate that Phaseolus vulgaris extract produces significant decrements in body weight and suggest decrements in fat mass in the face of maintained lean body mass. Key words: starch blockers, weight loss, obesity, amylase inhibitors, bean extract 1. Introduction World Health Organization (WHO) [12,13]. Strategies to lose body fat typically involve a Excess accumulation of body fat (over- combination of dietary changes limiting caloric intake, weight/obesity), a chronic disequilibrium between increased physical activity, behavioral therapy, phar- food consumption and energy expenditure, is becom- macotherapy, and, in extreme cases, surgery [1]. Al- ing noticeably more prevalent [1-4]. This is unfortu- though the availability and popularity of natural die- nate for more reasons than just poor physical appear- tary supplements intended to help with weight loss ance, because the overweight/obesity states increase has risen dramatically in recent years, their therapeu- the risk of hypertension, type II diabetes, arthritis, tic effectiveness remains uncertain in many cases. elevated circulating cholesterol, cancer, serious hor- Some providers of weight loss products tend to monal imbalances in women that can lead to sterility, over-hype the utility of dietary supplements without chronic renal disease, and even dementia and Alz- sufficient evidence, while many academic individuals heimer’s disease [1, 5-10]. Although it took an inordi- refuse to believe that natural weight-loss products nate length of time for widespread realization, it is have any therapeutic usefulness. Among potentially now generally recognized that overweight/obesity useful supplements to obtain healthy body propor- have reached epidemic proportions in the United tions are those containing "starch blockers," because States [11]. Further, this health problem is not limited over-consumption of rapidly-absorbed carbohydrates to America, because globally there are over one billion is frequently associated with obesity [14]. Theoreti- overweight adults according to many including the cally, starch blockers could promote weight loss by Int. J. Med. Sci. 2007, 4 46 interfering with and/or slowing the breakdown of 2. Methods complex carbohydrates, thereby reducing the diges- tive availability of carbohydrate-derived calories, at Study Design least early on, and/or favorably influencing the glu- EVIC ITALIA in Rome, Italy performed this cose-insulin system [15-20]. Also recent reports sug- randomized, double-blinded, placebo-controlled gest the possibility that “resistant starches’ may play study in accordance with the Helsinki Declaration and an important role in body weight loss [21]. other applicable laws related to the protection of study The present paper reports findings from a ran- subjects. Volunteers were recruited through a market domized, double-blinded, placebo-controlled investi- research company in Rome, Italy from a group of in- gation in which body weight and body fat composi- dividuals who expressed a willingness to participate tion of generally healthy, overweight human volun- in such evaluations. Eighty-two subjects, aged from teers were examined before and after a 30-day oral 20-45, found to be slightly overweight were selected treatment with placebo or a test formula containing a initially. Overweight was calculated using the follow- starch blocker as the principal active ingredient. [Phase ing formula: ideal weight (kg) = 100/(100 - % normal 2 Starch NeutralizerTM, also known as Phaseolamin 2250TM body fat) x lean mass. After calculating ideal weight, and Phase2TM (Pharmachem Laboratories, Inc., NJ)]. the overweight mass was estimated by measured body weight – ideal weight. The selection criteria listed in Table 1 were used to exclude or include study candidates. Table 1. Exclusion and Inclusion Criteria Prior to the initiation of study, each subject was The study diet provided approximately 2000 to 2200 questioned concerning the above exclusion and inclu- calories per day. All volunteers agreed to follow the sion criteria. nutritionist’s recommendations. The candidates were In order to obtain optimal compliance among entered into a 2-week single-blinded, run-in to en- subjects, it was deemed helpful to pre test participants, rollment and randomization. Subjects in this run-in i.e., would a given individual comply by maintaining period unknowingly received just placebo: the inves- the overall diet and taking one tablet before a meal tigators were aware that participants received inactive rich in carbohydrates? After providing written in- ingredients. formed consent, each volunteer was examined by a Sixty subjects from the original 82 with proven physician with expertise in nutrition, and given a body weight stability and deemed to be most compli- sheet with nutritional recommendations to be fol- ant with the expected criteria were subsequently se- lowed, including a daily intake of complex carbohy- lected for the study itself. The chosen participants re- drates concentrated in one of two main meals (Table 2). ported to the Center after 10, 20, and 30 days to have Int. J. Med. Sci. 2007, 4 47 their body weight checked and recorded. The two ple’s qualitative-quantitative formulas and the prod- groups took the assigned tablets, one tablet per day uct identification key was delivered to the principal before the main meal rich in complex carbohydrates investigator and kept at the disposal of the researchers for 30 consecutive days (Table 2). during the test period for any unexpected circum- The two provided tablet formulas were identified stances. Upon completion of the study, the envelope by the sponsor as Blokcal batch D106B (Test) and was opened in the presence of a representative of the Blokcal batch 1600301 (Placebo). Tablets were identical sponsor and of the Principal Investigator, and the in appearance so that the test and placebo tablets were representative formulas of the samples were identi- indistinguishable. An envelope containing the sam- fied. Table 2 A general summary of the meal plan used in the current study. Int. J. Med. Sci. 2007, 4 48 Test Products the investigation for the occurrence of any adverse or The active substance to be tested was an 800-mg side effects. tablet (Blokcal D106B) containing approximately Statistical Analysis 445mg (56% w/w) of Phase 2 Starch Neutralizer lV, a To minimize differences in beginning values be- dried aqueous extract of the common bean (Phaseolus tween subjects, they were stratified into two groups vulgaris). Phase 2 had been standardized to a mini- very similar in size, age, gender, and body weight dis- mum of 3000 AAlU (alpha-amylase inhibiting units), tribution. At completion, data from 30 subjects receiv- validated by a modified USP method (SOP 110, Rev.
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