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(12) Patent Application Publication (10) Pub. No.: US 2006/014 1075A1 Talbott (43) Pub US 2006O141075A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2006/014 1075A1 Talbott (43) Pub. Date: Jun. 29, 2006 (54) METHODS AND COMPOSITIONS FOR Publication Classification WEIGHT MANAGEMENT AND MOOD ENHANCEMENT (51) Int. Cl. A6IR 36/82 (2006.01) A6IR 36/752 (2006.01) (76) Inventor: Shawn M. Talbott, Draper, UT (US) A6II 3/522 (2006.01) A6II 3/56 (2006.01) Correspondence Address: A6IR 33/26 (2006.01) MACPHERSON KWOK CHEN & HEID LLP A 6LX 36/575 (2006.01) 1762 TECHNOLOGY DRIVE, SUITE 226 (52) U.S. Cl. ......................... 424/729; 424/736: 424/774; SAN JOSE, CA 95110 (US) 424/769; 514/263.31; 514/171; 424/646 (21) Appl. No.: 11/360,312 (57) ABSTRACT The present invention provides nutritional Supplement com (22) Filed: Feb. 23, 2006 positions and processes for treatment using nutritional Supplements that assist in weight management. One aspect Related U.S. Application Data of the invention comprises the inclusion in a single Supple ment constituent(s) that assist in reduction of a subjects (62) Division of application No. 10/895.253, filed on Jul. cortisol level, thermogenic constituent(s), and constituent(s) 20, 2004. that assist in stabilizing blood Sugar levels. Patent Application Publication Jun. 29, 2006 Sheet 1 of 4 US 2006/01.41075A1 Global Mood State (Profile of Mood States) 160 -8.6% 150 140 130 120 o Mood, Pre 110 Effect of a stress/cortisol-controlling dietary supplement on Global Mood States following 12 weeks of supplementation. P = placebo. S = Supplement. * = P <0.05 compared to Pre. # = P <0.05 compared to P. FIGURE 1 Patent Application Publication Jun. 29, 2006 Sheet 2 of 4 US 2006/01.41075A1 Salivary cortisol (ug/dL) 0.6 0.5 0.4 5: D Cortisol, Pre g Cortisol, Post O.3 P S Effect of a stress/cortisol-controlling dietary supplement on Salivary Cortisol (15 min post-waking) following 12-weeks of supplementation. P = placebo. S = Supplement. * = P <0.05 compared to Pre. # = P <0.05 compared to P. FIGURE 2 Patent Application Publication Jun. 29, 2006 Sheet 3 of 4 US 2006/01.41075A1 Body Weight (kg) and Waist Circumference (cm) A B 100 Effect of a stress/cortisol-controlling dietary supplement on (A) Body Weight (kg) and (B) Waist Circumference (cm) following 12-weeks of supplementation. P = placebo. S = Supplement. * = P <0.05 compared to Pre. FIGURE 3 Patent Application Publication Jun. 29, 2006 Sheet 4 of 4 US 2006/01.41075A1 Body Composition - Fat Mass and Lean Mass (kg) and Body Fat (%) A B 2 O -2 -4 -6 8 # oral loss ean Gain - 10 P S Effect of a stress/cortisol-controlling dietary supplement on Body Composition - (A) Fat Mass & Lean Mass (kg) and (B) Body Fat (%) following 12-weeks of supplementation. P = placebo. S = Supplement. # = P <0.05 compared to P. FIGURE 4 US 2006/0141 07S A1 Jun. 29, 2006 METHODS AND COMPOSITIONS FORWEIGHT 0015 FIG. 3B is a graph showing a change in waist MANAGEMENT AND MOOD ENHANCEMENT circumference with respect to a group of Subjects taking placebo and a nutritional Supplement in accordance with one CROSS-REFERENCE TO RELATED aspect of the present invention. APPLICATIONS 0016 FIG. 4A is a graph showing a change in fat mass 0001. Not applicable. and lean mass with respect to a group of Subjects taking placebo and a nutritional Supplement in accordance with one BACKGROUND OF THE INVENTION aspect of the present invention. 0002) 1. The Field of the Invention 0017 FIG. 4B is a graph showing a change in body fat 0003. The present invention is directed to treatments and with respect to a group of Subjects taking placebo and a nutritional Supplements that assist in reduction of cortisol, nutritional Supplement in accordance with one aspect of the cortisol effects, and assisting in weight loss and mood present invention. enhancement. DETAILED DESCRIPTION OF THE 0004 2. The Relevant Technology PREFERRED EMBODIMENTS 0005 There has been a large increase in the number of 0018. It is an aspect of the present invention to provide overweight and obese people in recent years. This leads to improved nutritional Supplements that are surprisingly a number of illnesses, as well as psychological issues arising effective for weight loss and in weight management. It is from people that are unhappy with their condition. another feature of the present invention to provide improved nutritional Supplements that are Surprisingly effective in 0006. Many different treatments have been proposed, improving mood. including exercise, diets, and nutritional Supplements. 0019. It is another aspect of the present invention to 0007 Some people have implicated cortisol in weight provide improved nutritional Supplements that assist in gain, and have proposed that ingestion of cortisol-reducing reduction of cortisol levels. The hormone cortisol is impor Supplements can assist in controlling one’s weight. Although tant in Small amounts to regulate carbohydrate metabolism, there has been Some very promising research regarding the inflammation and cardiovascular function. It also plays a benefits of reducing cortisol, much improvement is needed role in increasing blood pressure and blood Sugar levels to find suitable nutritional supplements to assist with weight under some circumstances. management. 0020. Unfortunately, there is now evidence that increased BRIEF SUMMARY OF THE INVENTION levels of cortisol leads to an increase in abdominal fat accumulation. An increased cortisol level has also been 0008. The present invention provides nutritional supple implicated in a disruption of energy metabolism that can ment compositions and processes for treatment using nutri result in the development of a condition known as Metabolic tional Supplements that assist in weight management. Syndrome X. In studies of stress and cortisol exposure, high 0009. One aspect of the invention comprises the inclusion cortisol secretion has been associated specifically with in a single Supplement constituent(s) that assist in reduction abdominal fat, and abdominal fathas in turn been associated of a Subject’s cortisol level, thermogenic constituent(s), and with illness and death from cardiovascular disease, diabetes, constituent(s) that assist in stabilizing blood Sugar levels. hypertension, hyperlipidemia, hyperinsulinemia, and insulin resistance. Women with a high cortisol response, compared 0010 Another aspect of the invention is a process for to low responders, in evaluations of stress response, have assisting in weight management comprising the ingestion of been shown to consume more total calories, more calories a suitable nutritional supplements with breakfast and with from Sweet and fatty foods (“comfort' foods), and report lunch. more negative moods. Hence, although cortisol is an impor 0011. These and other aspects of the present invention tant hormone having a very important function in healthy will become more fully apparent from the following descrip adults, abnormally high levels of cortisol are unhealthy. tion and appended claims, or may be learned by the practice 0021 Even the stress of dieting and dietary restraint has of the invention as set forth hereinafter. been associated with elevations in cortisol. This makes BRIEF DESCRIPTION OF THE DRAWINGS traditional dieting or dietary restraint counterproductive and difficult to maintain. 0012 FIG. 1 is a graph showing a change in profile of 0022. In accordance with the present invention, a par mood states with respect to a group of Subjects taking ticularly useful composition suitable for reduction of cortisol placebo and a nutritional Supplement in accordance with one levels has been identified. In one embodiment, this compo aspect of the present invention. sition includes an extract of magnolia bark, L-theanine, and 0013 FIG. 2 is a graph showing a change in the salivary beta-sitosterol. A currently preferred composition contains cortisol level with respect to a group of Subjects taking 100 mg of magnolia bark extract that is standardized to placebo and a nutritional Supplement in accordance with one contain 1.5% honokiol; 25 mg of L-theanine (98% pure); aspect of the present invention. and 30 mg of beta-sitosterol. It is preferred that this com 0014 FIG. 3A is a graph showing a change in body position be taken twice a day, once with breakfast and again weight with respect to a group of Subjects taking placebo and with lunch. a nutritional Supplement in accordance with one aspect of 0023. It will be understood by those of ordinary skill in the present invention. the art that other substances that result in a reduction of US 2006/0141 07S A1 Jun. 29, 2006 cortisol may be used in place of those listed above. For min C, and vitamin P. Additionally, oil soluble vitamins that example, other Suitable cortisol modulating ingredients may be used include without limitation, Vitamin A, Vitamin include, without limitation, Ashwagandha, Epimedium, Gar D. Vitamin E, and vitamin K. Amino acids other than those lic, and Phosphatidylserine. Various cortisol modulating recited above, may include without limitation, alanine, argi Substances may be used individually or in combination with nine, carnitine, gamma-aminobutyric acid (GABA), other Substances. glutamine, glycine, histidine, lysine, methionine, N-acetyl 0024 Moreover, the source and amount of each cortisol cysteine, ornithine, phenylalanine, and taurine. Ionic min modulating Substance may be selected in order to provide a erals that may be use include both anionic and cationic particular product. For example, each cortisol modulator minerals. Further, examples of suitable anti-oxidants include may be obtained from natural sources and presented in a low without limitation, tea extract, Such as green tea, oolong, and to moderate dosage, in order to provide a natural product black teas, grape seed, beta-carotene, and co-enzyme Q-10. that can be used as a holistic treatment or nutritional Specific examples of beneficial enzymes include bromelain supplement. Cortisol modulators from either natural or and papain, as well as others.
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