Obesity
Conditions
Keywords
conjugated linoleic acid, obesity, body composition, body fat mass, lean body mass
Brief summary
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.
Detailed description
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.
Interventions
DRUGTonalin Conjugated linoleic acid (dietary supplement)
Sponsors
Cognis
University of North Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI between 30 and 35 kg/m2
Exclusion criteria
* history of chronic disease * food allergies or intolerances * drug therapy for diagnosed disease or lipid-lowering * use of weight-lowering medication or diet * use of tobacco products * current or planned pregnancy * use of CLA supplement in previous 3 months * current substance abuse * abnormal clinical laboratory values
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in lean body mass at 12 weeks | — |
| Change in body weight at 12 weeks | — |
| Change in energy expenditure at 12 weeks | — |
| Change in body fat mass at 12 weeks | — |
| Change in body mass index at 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in clinical laboratory values at 6 weeks and 12 weeks (safety) | — |
| Change in lipid profile at 6 weeks and 12 weeks | — |
Countries
United States
Outcome results
None listed