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Sponsors and Collaborators: |
University of North Carolina Cognis |
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Information provided by: | The University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT00347373 |
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.
Condition | Intervention |
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Obesity |
Drug: Tonalin Conjugated linoleic acid (dietary supplement) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Conjugated Linoleic Acid and Body Fat Mass in Obese Humans |
Estimated Enrollment: | 60 |
Study Start Date: | August 2004 |
Estimated Study Completion Date: | September 2005 |
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.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, North Carolina | |
University of North Carolina at Chapel Hill | |
Chapel Hill, North Carolina, United States, 27599 |
Principal Investigator: | Susan E Steck, PhD, MPH, RD | The University of North Carolina, Chapel Hill |
Study ID Numbers: | GCRC2166 |
Study First Received: | June 30, 2006 |
Last Updated: | June 30, 2006 |
ClinicalTrials.gov Identifier: | NCT00347373 |
Health Authority: | United States: Institutional Review Board |
conjugated linoleic acid obesity body composition body fat mass lean body mass |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |