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
  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:


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:
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 April 16, 2014