Effect of Conjugated Linoleic Acid Supplement on Body Composition

Study Overview
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Brief Summary
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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
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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.

Official Title
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Conjugated Linoleic Acid and Body Fat Mass in Obese Humans

Conditions
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Obesity

Intervention / Treatment
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* Drug: Tonalin Conjugated linoleic acid (dietary supplement)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tonalin Conjugated linoleic acid (dietary supplement)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lipid profile at 6 weeks and 12 weeks |  |  | 
| Change in clinical laboratory values at 6 weeks and 12 weeks (safety) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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conjugated linoleic acid, obesity, body composition, body fat mass, lean body mass