Effects of CLA Supplements on Body Weight and Fat Oxidation

Phase 2

Completed

• Conditions: Obesity
• Interventions: Drug: conjugated linoleic acid

• Registration Number: NCT00204932
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-07
• Primary Completion: 2005-03
• Study Completion: 2005-03
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Results First Submitted: 2011-08-04
• Results First Submitted QC: 2014-12-18
• Results First Posted: 2014-12-22
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-18
• Last Update Posted: 2018-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CLA treatment	conjugated linoleic acid	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
Placebo	conjugated linoleic acid	The group randomized to control received 4 g/d of safflower oil.

Primary Outcome Measures

Name	Time	Method
Fat Mass	6 months	loss of fat mass, kg

Secondary Outcome Measures

Name	Time	Method
Total Fat Oxidation	6 months	24 hour respiratory gas analysis

Trial Locations

Locations (1)

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States