The purpose of this clinical trial is to examine the effects of a low and high dose of conjugated linoleic acid supplement on body composition in obese humans. Individuals with a body mass index between 30 and 35kg/m2 are randomized to receive either placebo, 3.2gCLA, or 6.4g CLA daily for twelve weeks. Changes in body composition, weight, and clinical laboratory values are compared between the three groups.
Sixty healthy obese adult volunteers will be enrolled and randomized into either: 1) placebo, 2) 3.2 g CLA, or 3) 6.4 g CLA groups and supplemented for 12 weeks. Body fat mass (BFM) and lean body mass will be determined by DEXA at baseline and twelve weeks during the intervention. In addition, indirect calorimetry will be performed at baseline and twelve weeks to measure changes in energy expenditure. The effect of CLA supplementation on weight, waist and hip measurements, and BMI will also be determined at 12 weeks. Plasma CLA and pill counts will be measured as an indication of compliance. Several blood parameters will be monitored throughout the study, and five random 24-hour recall surveys will be used to monitor dietary intake of CLA-rich foods, energy, micronutrients and antioxidants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Change in body fat mass at 12 weeks
Change in lean body mass at 12 weeks
Change in body mass index at 12 weeks
Change in body weight at 12 weeks
Change in energy expenditure at 12 weeks
Change in lipid profile at 6 weeks and 12 weeks
Change in clinical laboratory values at 6 weeks and 12 weeks (safety)
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