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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
  Purpose
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.

Condition Intervention
Obesity
 Drug: Tonalin Conjugated linoleic acid (dietary supplement)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Conjugated Linoleic Acid and Body Fat Mass in Obese Humans

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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:
  • Change in lipid profile at 6 weeks and 12 weeks
  • Change in clinical laboratory values at 6 weeks and 12 weeks (safety)
Estimated Enrollment: 60
Study Start Date: August 2004
Estimated Study Completion Date: September 2005
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.
  Eligibility
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00347373

Locations
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina
Cognis
Investigators
Principal Investigator: Susan E Steck, PhD, MPH, RD University of North Carolina, Chapel Hill
  More Information

ClinicalTrials.gov Identifier: NCT00347373     History of Changes
Other Study ID Numbers: GCRC2166 
Study First Received: June 30, 2006
Last Updated: June 30, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
conjugated linoleic acid
obesity
body composition
body fat mass
lean body mass

ClinicalTrials.gov processed this record on September 30, 2016