Effect of Conjugated Linoleic Acid Supplement on Body Composition

Conjugated Linoleic Acid and Body Fat Mass in Obese Humans

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: Tonalin Conjugated linoleic acid (dietary supplement)

Detailed Description

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.

• Study Type: Interventional
• Enrollment: 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Change in lipid profile at 6 weeks and 12 weeks
Change in clinical laboratory values at 6 weeks and 12 weeks (safety)

Collaborators and Investigators

• Sponsor: University of North Carolina
• Collaborators: Cognis
• Investigators: Principal Investigator: Susan E Steck, PhD, MPH, RD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start: August 1, 2004
• Study Completion: September 1, 2005

Study Registration Dates

• First Submitted: June 30, 2006
• First Submitted That Met QC Criteria: June 30, 2006
• First Posted (ESTIMATE): July 4, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): July 4, 2006
• Last Update Submitted That Met QC Criteria: June 30, 2006
• Last Verified: June 1, 2006

More Information

Terms related to this study

• Keywords: obesity; body composition; conjugated linoleic acid; lean body mass; body fat mass
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: GCRC2166