Effects of CLA Supplements on Body Weight and Fat Oxidation

Study Overview
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Brief Summary
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Conjugated linoleic acid (CLA) is form of fat found in dairy foods, beef and other natural sources. When given to small animals, decreases of body fat have been noted.. Although weight loss is the best treatment for overweight and obesity, it is difficult to maintain the loss in the long term. Because of this, treatment emphasis has turned to small weight losses obtained through non-restrictive diets and prevention of weight regain. This is a study to determine if 6 months of consumption a purified form of CLA will result in greater loss of body fat than control and to determine whether CLA consumption increases total fat oxidation, which would help explain why the weight loss occurs.

Detailed Description
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Subjects were screened and then underwent baseline evaluation. The substudy evaluation measured 24-h energy expenditure and substrate utilization by using a whole-room indirect calorimeter. Dietary fat oxidation was measured by mixing [1-13C]oleate and D31-palmitate into a breakfast meal and then collecting breath carbon dioxide and urine to measure the end products of oxidation. Subjects were then provided either 4 g/d of 78% active CLA isomers (3.2 g/d: 39.2% cis-9,trans-11 and 38.5% trans-10,cis-12) or 4 g/d of safflower oil placebo as 1-g gel capsule supplements. The baseline evaluations were repeated 6 mo later.

Official Title
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Effects of CLA Supplements on Body Weight and Fat Oxidation

Conditions
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Obesity

Intervention / Treatment
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* Drug: conjugated linoleic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI 25-29.9 kg/m2 Absence of a weight change of greater than 3 kg in the previous 6 months Exclusion Criteria: Presence of a physical limitation to walking exercise Current or recent (6 months) enrollment in a commercial or self-prescribed weight loss program A history of metabolic disease-ie. renal, endocrine, hepatic or gastrointestinal disease that would impact the outcome of the study A history of a psychiatric or eating disorders Ÿ Presence of metal implants that would interfere with body composition analysis Fasting plasma cholesterol >300mg/dl or triglycerides above 500 mg/dl. Abnormal EKG

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CLA treatment<br>The group randomized to Conjugated Linoleic Acid (CLA) treatment at 4 grams per day of 39% cis-9, trans-11 CLA; 39% trans-10, cis-12 CLA; and 22% safflower oil for 6 months | Drug: conjugated linoleic acid<br>* 4 grams per day of 39% cis-9, trans-11 CLA; 39% trans-10, cis-12 CLA, and 22% safflower oil for 6 months<br>|
| Placebo Comparator: Placebo<br>The group randomized to control received 4 g/d of safflower oil. | Drug: conjugated linoleic acid<br>* 4 grams per day of 39% cis-9, trans-11 CLA; 39% trans-10, cis-12 CLA, and 22% safflower oil for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat Mass | loss of fat mass, kg | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Fat Oxidation | 24 hour respiratory gas analysis | 6 months |