Home | Current Issue | Past Issues | Search | CollectionsRSS | PDA Services | FAQ | SHCIM Online | Chinese Updated Monday, September 25, 2017
 Services
Submit a manuscript
Subscribe
Individuals
Institutions
Response
Send response
Read responses
Reprint
Advance online publication
Sign up for e-alert
JCIM job opportunities
Contact JCIM
 Information For
Readers
Authors
Reviewers
Advertisers
 About JCIM
Journal description
Editorial policy
Privacy policy
Copy right
Editorial staff
 Language Polishing
Journal of Chinese Integrative Medicine: 2011; 9(11): 1190-1198
DOI: 10.3736/jcim20111106
Investigations of botanicals on food intake, satiety, weight loss and oxidative stress: study protocol of a double-blind, placebo-controlled, crossover study
1. Stephen D. Anton (Department of Aging and Geriatric Research, University of Florida, Gainesville, Florida 32611, USA E-mail: santon@ufl.edu, cleeuwen@aging.ufl.edu)
2. Jonathan Shuster (Department of Health Outcomes and Policy, University of Florida, Gainesville, Florida 32611, USA )
3. Christiaan Leeuwenburgh (Department of Aging and Geriatric Research, University of Florida, Gainesville, Florida 32611, USA )
Background: Botanicals represent an important and underexplored source of potential new therapies that may facilitate caloric restriction and thereby may produce long-term weight loss. In particular, one promising botanical that may reduce food intake and body weight by affecting neuroendocrine pathways related to satiety is hydroxycitric acid (HCA) derived from Garcinia cambogia Desr.
Methods and design: The objective of this article is to describe the protocol of a clinical trial designed to directly test the effects of Garcinia cambogia-derived HCA on food intake, satiety, weight loss and oxidative stress levels, and to serve as a model for similar trials. A total of 48 healthy, overweight or obese individuals (with a body mass index range of 25.0 to 39.9 kg/m2) between the ages of 50 to 70 will participate in this double-blind, placebo-controlled, crossover study designed to examine the effects of two doses of Garcinia cambogia-derived HCA on food intake, satiety, weight loss, and oxidative stress levels. Food intake represents the primary outcome measure and is calculated based on the total calories consumed at breakfast, lunch, and dinner meals during each test meal day. This study can be completed with far fewer subjects than a parallel design.
Discussion: Of the numerous botanical compounds, the compound Garcinia cambogia-derived HCA is selected for testing in the present study because of its potential to safely reduce food intake, body weight, and oxidative stress levels. We will review potential mechanisms of action and safety parameters throughout this clinical trial.
Trial registration: ClinicalTrials.gov (Identifier: NCT01238887).
Welcome to JCIM! You are the number 21495 reader of this article!
Download Article:
[Full Text]      [PDF]      [Chinese]      [Previous]      [Next]      [This Issue]
Please cite this article as:
Anton SD, Shuster J, Leeuwenburgh C. Investigations of botanicals on food intake, satiety, weight loss and oxidative stress: study protocol of a double-blind, placebo-controlled, crossover study. J Chin Integr Med / Zhong Xi Yi Jie He Xue Bao. 2011; 9(11): 1190-1198.
References:
1Kenchaiah S, Evans JC, Levy D, Wilson PW, Benjamin EJ, Larson MG, Kannel WB, Vasan RS. Obesity and the risk of heart failure[J].N Engl J Med, 2002, 347(5): 305-313.  .
2Key TJ, Allen NE, Spencer EA, Travis RC. The effect of diet on risk of cancer[J].Lancet, 2002, 360(9336): 861-868.  .
3Roth J, Qiang X, Marban SL, Redelt H, Lowell BC. The obesity pandemic: where have we been and where are we going? Obes Res. 2004; 12(Suppl 2): 88S-101S.
4Das M, Gabriely I, Barzilai N. Caloric restriction, body fat and ageing in experimental models[J].Obes Rev, 2004, 5(1): 13-19.  .
5Kloting N, Blüher M. Extended longevity and insulin signaling in adipose tissue[J].Exp Gerontol, 2005, 40(11): 878-883.  .
6Roth GS, Ingram DK, Joseph JA. Nutritional interventions in aging and age-associated diseases[J].Ann N Y Acad Sci, 2007, 1114: 369-371.  .
7Bodkin NL, Alexander TM, Ortmeyer HK, Johnson E, Hansen BC. Mortality and morbidity in laboratory-maintained Rhesus monkeys and effects of long-term dietary restriction[J].J Gerontol A Biol Sci Med Sci, 2003, 58(3): 212-219.  .
8Kayo T, Allison DB, Weindruch R, Prolla TA. Influences of aging and caloric restriction on the transcriptional profile of skeletal muscle from rhesus monkeys[J].Proc Natl Acad Sci U S A, 2001, 98(9): 5093-5098.  .
9Heilbronn LK, de Jonge L, Frisard MI, DeLany JP, Larson-Meyer DE, Rood J, Nguyen T, Martin CK, Volaufova J, Most MM, Greenway FL, Smith SR, Deutsch WA, Williamson DA, Ravussin E; Pennington CALERIE Team. Effect of 6-month calorie restriction on biomarkers of longevity, metabolic adaptation, and oxidative stress in overweight individuals: a randomized controlled trial[J].JAMA, 2006, 295(13): 1539-1548.  .
10Goldstein DJ. Beneficial health effects of modest weight loss[J].Int J Obes Relat Metab Disord, 1992, 16(6): 397-415.  .
11Scheen AJ. The future of obesity: new drugs versus lifestyle interventions[J].Expert Opin Investig Drugs, 2008, 17(3): 263-267.  .
12McGuire MT, Wing RR, Klem ML, Lang W, Hill JO. What predicts weight regain in a group of successful weight losers? J Consult Clin Psychol. 1999; 67(2): 177-185.
13MacLean PS, Higgins JA, Jackman MR, Johnson GC, Fleming-Elder BK, Wyatt HR, Melanson EL, Hill JO. Peripheral metabolic responses to prolonged weight reduction that promote rapid, efficient regain in obesity-prone rats[J].Am J Physiol Regul Integr Comp Physiol, 2006, 290(6): R1577-R1588.  .
14Blanck HM, Khan LK, Serdula MK. Use of nonprescription weight loss products: results from a multistate survey[J].JAMA, 2001, 286(8): 930-935.  .
15Goldman EL. Industry self-regulation in the manufacture of dietary supplements and botanical medicines[J].Clin Obstet Gynecol, 2001, 44(4): 789-800.  .
16Pittler MH, Ernst E. Complementary therapies for reducing body weight: a systematic review[J].Int J Obes (Lond), 2005, 29(9): 1030-1038.  .
17Bray GA. Are non-prescription medications needed for weight control? Obesity (Silver Spring). 2008; 16(3): 509-514.
18Clouatre D, Talpur N, Talpur F, Echard B, Preuss H. Comparing metabolic and inflammatory parameters among rats consuming different forms of hydroxycitrate. The American College of Nutrition 46th Annual Meeting, Kiawah Island, South Carolina, September 22-25, 2005.
19Clouatre DL, Preuss HG. Potassium magnesium hydroxycitrate at physiologic levels influences various metabolic parameters and inflammation in rats[J].Curr Top Nutraceutical Res, 2008, 6(4): 201-210.  .
20Greenwood MR, Cleary MP, Gruen R, Blase D, Stern JS, Triscari J, Sullivan AC. Effect of (-)-hydroxycitrate on development of obesity in the Zucker obese rat[J].Am J Physiol, 1981, 240(1): E72-E78.  .
21Leonhardt M, Hrupka B, Langhans W. Effect of hydroxycitrate on food intake and body weight regain after a period of restrictive feeding in male rats[J].Physiol Behav, 2001, 74(1-2): 191-196.  .
22Asghar M, Monjok E, Kouamou G, Ohia SE, Bagchi D, Lokhandwala MF. Super CitriMax (HCA-SX) attenuates increases in oxidative stress, inflammation, insulin resistance, and body weight in developing obese Zucker rats[J].Mol Cell Biochem, 2007, 304(1-2): 93-99.  .
23Heymsfield SB, Allison DB, Vasselli JR, Pietrobelli A, Greenfield D, Nunez C. Garcinia cambogia (hydroxycitric acid) as a potential antiobesity agent: a randomized controlled trial[J].JAMA, 1998, 280(18): 1596-1600.  .
24Westerterp-Plantenga MS, Kovacs EM. The effect of (-)-hydroxycitrate on energy intake and satiety in overweight humans[J].Int J Obes Relat Metab Disord, 2002, 26(6): 870-872.  .
25Sullivan AC, Hamilton JG, Miller ON, Wheatley VR. Inhibition of lipogenesis in rat liver by (-)-hydroxycitrate[J].Arch Biochem Biophys, 1972, 150(1): 183-190.  .
26McCarty MF. Promotion of hepatic lipid oxidation and gluconeogenesis as a strategy for appetite control[J].Med Hypotheses, 1994, 42(4): 215-225.  .
27Roy S, Shah H, Rink C, Khanna S, Bagchi D, Bagchi M, Sen CK. Transcriptome of primary adipocytes from obese women in response to a novel hydroxycitric acid-based dietary supplement[J].DNA Cell Biol, 2007, 26(9): 627-639.  .
28Shara M, Ohia SE, Yasmin T, Zardetto-Smith A, Kincaid A, Bagchi M, Chatterjee A, Bagchi D, Stohs SJ. Dose- and time-dependent effects of a novel (-)-hydroxycitric acid extract on body weight, hepatic and testicular lipid peroxidation, DNA fragmentation and histopathological data over a period of 90 days[J].Mol Cell Biochem, 2003, 254(1-2): 339-346.  .
29Anton SD, Morrison CD, Cefalu WT, Martin CK, Coulon S, Geiselman P, Han H, White CL, Williamson DA. Effects of chromium picolinate on food intake and satiety[J].Diabetes Technol Ther, 2008, 10(5): 405-412.  .
30Beck AT, Steer RA, Brown GK. Manual for the Beck Depression Inventory-Ⅱ. San Antonio: Psychological Corporation. 1996.
31Stunkard AJ, Messick S. The three-factor eating questionnaire to measure dietary restraint, disinhibition and hunger[J].J Psychosom Res, 1985, 29(1): 71-83.  .
32Stice E, Telch CF, Rizvi SL. Development and validation of the Eating Disorder Diagnostic Scale: a brief self-report measure of anorexia, bulimia, and binge-eating disorder[J].Psychol Assess, 2000, 12(2): 123-131.  .
33Stice E, Fisher M, Martinez E. Eating disorder diagnostic scale: additional evidence of reliability and validity[J].Psychol Assess, 2004, 16(1): 60-71.  .
34Kissileff HR, Klingsberg G, Van Itallie TB. Universal eating monitor for continuous recording of solid or liquid consumption in man[J].Am J Physiol, 1980, 238(1): R14-R22.  .
35Kissileff HR, Thornton J, Becker E. A quadratic equation adequately describes the cumulative food intake curve in man[J].Appetite, 1982, 3(3): 255-272.  .
36Flint A, Raben A, Blundell JE, Astrup A. Reproducibility, power and validity of visual analogue scales in assessment of appetite sensations in single test meal studies[J].Int J Obes Relat Metab Disord, 2000, 24(1): 38-48.  .
37White MA, Whisenhunt BL, Williamson DA, Greenway FL, Netemeyer RG. Development and validation of the food-craving inventory[J].Obes Res, 2002, 10(2): 107-114.  .
38Hofer T, Seo AY, Prudencio M, Leeuwenburgh C. A method to determine RNA and DNA oxidation simultaneously by HPLC-ECD: greater RNA than DNA oxidation in rat liver after doxorubicin administration[J].Biol Chem, 2006, 387(1): 103-111.  .
39Shuster JJ. Design of experiments. In, Ambrosius WT. Methods in molecular biology: elementary biostatistics[M]. Totawa: Humana Press, 2007. 235-260.  .
40Hayamizu K, Ishii Y, Kaneko I, Shen M, Okuhara Y, Sakaguchi H, Shigematsu N, Shimasaki H. No-observed-adverse-effect level (NOAEL) and sequential-high doses administration study on Garcinia cambogia extract in humans[J].J Oleo Sci, 2002, 51(5): 365-369.  .
41Adam TC, Westerterp-Plantenga MS. Glucagon-like peptide-1 release and satiety after a nutrient challenge in normal-weight and obese subjects[J].Br J Nutr, 2005, 93(6): 845-851.  .
42Keim NL, Stern JS, Havel PJ. Relation between circulating leptin concentrations and appetite during a prolonged, moderate energy deficit in women[J].Am J Clin Nutr, 1998, 68(4): 794-801.  .
43Rosenbaum M, Nicolson M, Hirsch J, Murphy E, Chu F, Leibel RL. Effects of weight change on plasma leptin concentrations and energy expenditure[J].J Clin Endocrinol Metab, 1997, 82(11): 3647-3654.  .
44Levin BE. The drive to regain is mainly in the brain[J].Am J Physiol Regul Integr Comp Physiol, 2004, 287(6): R1297-R1300.  .
45Levine JA. Nonexercise activity thermogenesis (NEAT): environment and biology[J].Am J Physiol Endocrinol Metab, 2004, 286(5): E675-E685.  .

 Home | Current Issue | Past Issues | Search | CollectionsRSS | PDA Services | FAQ | SHCIM Online | Chinese
Copyright © 2003-2012 by JCIM Press. All rights reserved. ISSN 1672-1977