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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).
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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.
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