title: Investigations of botanicals on food intake, satiety, weight loss and oxidative stress: study protocol of a double-blind, placebo-controlled, crossover study.
abstract: 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
  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/m(2)) 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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov (Identifier: NCT01238887).
authors.affiliation: Department of Aging and Geriatric Research, University of Florida, Gainesville, Florida 32611, USA. santon@ufl.edu
authors.forename: Stephen D
authors.initials: SD
authors.lastname: Anton
authors.forename: Jonathan
authors.initials: J
authors.lastname: Shuster
authors.forename: Christiaan
authors.initials: C
authors.lastname: Leeuwenburgh
mesh_terms: D000368:Aged; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000494:pharmacology*; D004435:Eating / Q000187:drug effects; D006801:Humans; D008875:Middle Aged; D050177:Overweight; D018384:Oxidative Stress / Q000187:drug effects*; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D012527:Satiation / Q000187:drug effects*; D015431:Weight Loss / Q000187:drug effects*
chemical_list: D004365:Drugs, Chinese Herbal
references.citation: J Psychosom Res. 1985;29(1):71-83
references.pmid: 3981480
references.citation: Obesity (Silver Spring). 2008 Mar;16(3):509-14
references.pmid: 18239604
references.citation: Am J Physiol. 1981 Jan;240(1):E72-8
references.pmid: 7457600
references.citation: Am J Clin Nutr. 1998 Oct;68(4):794-801
references.pmid: 9771856
references.citation: J Gerontol A Biol Sci Med Sci. 2003 Mar;58(3):212-9
references.pmid: 12634286
references.citation: DNA Cell Biol. 2007 Sep;26(9):627-39
references.pmid: 17708719
references.citation: Ann N Y Acad Sci. 2007 Oct;1114:369-71
references.pmid: 17986597
references.citation: Obes Rev. 2004 Feb;5(1):13-9
references.pmid: 14969503
references.citation: Psychol Assess. 2000 Jun;12(2):123-31
references.pmid: 10887758
references.citation: Psychol Assess. 2004 Mar;16(1):60-71
references.pmid: 15023093
references.citation: Int J Obes Relat Metab Disord. 2000 Jan;24(1):38-48
references.pmid: 10702749
references.citation: Clin Obstet Gynecol. 2001 Dec;44(4):789-800
references.pmid: 11600860
references.citation: Am J Physiol Regul Integr Comp Physiol. 2004 Dec;287(6):R1297-300
references.pmid: 15528399
references.citation: Exp Gerontol. 2005 Nov;40(11):878-83
references.pmid: 16125891
references.citation: Int J Obes Relat Metab Disord. 2002 Jun;26(6):870-2
references.pmid: 12037659
references.citation: Int J Obes (Lond). 2005 Sep;29(9):1030-8
references.pmid: 15925954
references.citation: JAMA. 1998 Nov 11;280(18):1596-600
references.pmid: 9820262
references.citation: Diabetes Technol Ther. 2008 Oct;10(5):405-12
references.pmid: 18715218
references.citation: Physiol Behav. 2001 Sep 1-15;74(1-2):191-6
references.pmid: 11564468
references.citation: J Clin Endocrinol Metab. 1997 Nov;82(11):3647-54
references.pmid: 9360521
references.citation: Expert Opin Investig Drugs. 2008 Mar;17(3):263-7
references.pmid: 18321226
references.citation: Arch Biochem Biophys. 1972 May;150(1):183-90
references.pmid: 5028073
references.citation: Am J Physiol Endocrinol Metab. 2004 May;286(5):E675-85
references.pmid: 15102614
references.citation: Proc Natl Acad Sci U S A. 2001 Apr 24;98(9):5093-8
references.pmid: 11309484
references.citation: Mol Cell Biochem. 2007 Oct;304(1-2):93-9
references.pmid: 17503004
references.citation: Biol Chem. 2006 Jan;387(1):103-11
references.pmid: 16497170
references.citation: Lancet. 2002 Sep 14;360(9336):861-8
references.pmid: 12243933
references.citation: JAMA. 2001 Aug 22-29;286(8):930-5
references.pmid: 11509057
references.citation: Mol Cell Biochem. 2003 Dec;254(1-2):339-46
references.pmid: 14674714
references.citation: N Engl J Med. 2002 Aug 1;347(5):305-13
references.pmid: 12151467
references.citation: J Consult Clin Psychol. 1999 Apr;67(2):177-85
references.pmid: 10224727
references.citation: JAMA. 2006 Apr 5;295(13):1539-48
references.pmid: 16595757
references.citation: Am J Physiol Regul Integr Comp Physiol. 2006 Jun;290(6):R1577-88
references.pmid: 16455763
references.citation: Br J Nutr. 2005 Jun;93(6):845-51
references.pmid: 16022753
references.citation: Obes Res. 2002 Feb;10(2):107-14
references.pmid: 11836456
references.citation: Int J Obes Relat Metab Disord. 1992 Jun;16(6):397-415
references.pmid: 1322866
references.citation: Appetite. 1982 Sep;3(3):255-72
references.pmid: 7159076
references.citation: Med Hypotheses. 1994 Apr;42(4):215-25
references.pmid: 8072427
references.citation: Am J Physiol. 1980 Jan;238(1):R14-22
references.pmid: 7356043
references.citation: Obes Res. 2004 Nov;12 Suppl 2:88S-101S
references.pmid: 15601956