Effect of Conjugated Linoleic Acid Supplement on Body Composition - Full Text View

Sponsors and Collaborators:	University of North Carolina Cognis
Information provided by:	The University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00347373

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)

MedlinePlus related topics: Dietary Supplements Obesity

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Conjugated Linoleic Acid and Body Fat Mass in Obese Humans

Further study details as provided by The 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
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

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

The University of North Carolina, Chapel Hill

More Information

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

Keywords provided by The University of North Carolina, Chapel Hill:

conjugated linoleic acid
obesity
body composition
body fat mass
lean body mass

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on January 14, 2009