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Effect of Conjugated Linoleic Acid on Body Fat in Overweight Children

This study has been completed.
Sponsor:
Collaborator:
Loders Croklaan
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00575991
First received: December 14, 2007
Last updated: March 12, 2012
Last verified: March 2012
History of Changes
  Purpose

The prevalence of overweight children has increased dramatically over the last decade, and many overweight children will remain overweight as adults. Conjugated linoleic acid (CLA), a naturally occurring dietary fatty acid, has shown promising results in reducing body fat among adults, and we propose to test the efficacy of CLA supplementation on body fat accretion in 6 to 10 year old children who are overweight or at risk of overweight.


Condition Intervention
Overweight
 Dietary Supplement: Conjugated linoleic acid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of CLA Supplementation on Body Fat Accretion Among Children Who Are Overweight or at Risk of Overweight

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • body composition using DXA [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • blood chemistry variables including fasting glucose and insulin, lipids, and liver enzymes [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 62
Study Start Date: January 2007
Study Completion Date: September 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Dietary Supplement: Conjugated linoleic acid
3 grams per day of 80% CLA in safflower oil (2.4 grams active CLA isomers in triglyceride form)
Placebo Comparator: B Dietary Supplement: Conjugated linoleic acid
3 grams per day of 80% CLA in safflower oil (2.4 grams active CLA isomers in triglyceride form)

  Eligibility

Ages Eligible for Study:   6 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 6 to 10 years
  • body mass index greater than 85th percentile
  • Tanner stage I

Exclusion Criteria:

  • medical condition
  • dairy allergy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00575991

Locations
United States, Wisconsin
University of Wisconsin Department of Nutritional Sciences
Madison, Wisconsin, United States, 53706
Sponsors and Collaborators
University of Wisconsin, Madison
Loders Croklaan
Investigators
Principal Investigator: Dale A Schoeller, PhD University of Wisconsin, Madison
  More Information

Additional Information:
Publication  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00575991     History of Changes
Other Study ID Numbers: H2006-0300
Study First Received: December 14, 2007
Last Updated: March 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
conjugated linoleic acid, body fat, children, overweight

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013