Effect of Conjugated Linoleic Acid Supplement on Body Composition

This study has been completed.
Sponsor:
Collaborator:
Cognis
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00347373
First received: June 30, 2006
Last updated: NA
Last verified: June 2006
History: No changes posted

June 30, 2006
June 30, 2006
August 2004
Not Provided
  • 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
Same as current
No Changes Posted
  • Change in lipid profile at 6 weeks and 12 weeks
  • Change in clinical laboratory values at 6 weeks and 12 weeks (safety)
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Obesity
Drug: Tonalin Conjugated linoleic acid (dietary supplement)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 2005
Not Provided

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
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00347373
GCRC2166
Not Provided
Not Provided
University of North Carolina
Cognis
Principal Investigator: Susan E Steck, PhD, MPH, RD University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP