Effect of Conjugated Linoleic Acid Supplement on Body Composition
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Purpose
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 |
|---|---|
|
Obesity |
Drug: Tonalin Conjugated linoleic acid (dietary supplement) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Conjugated Linoleic Acid and Body Fat Mass in Obese Humans |
- 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)
| 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.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00347373
| 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 | University of North Carolina, Chapel Hill |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00347373 History of Changes |
| Other Study ID Numbers: | GCRC2166 |
| Study First Received: | June 30, 2006 |
| Last Updated: | June 30, 2006 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of North Carolina, Chapel Hill:
|
conjugated linoleic acid obesity body composition body fat mass lean body mass |
ClinicalTrials.gov processed this record on February 27, 2015