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 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:

MedlinePlus related topics: Dietary Supplements

Drug Information available for: Linoleic acid

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)
Sexes Eligible for Study:	All
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

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 June 28, 2017

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