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Effect of Conjugated Linoleic Acid on Body Fat in Overweight Children

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ClinicalTrials.gov Identifier: NCT00575991
Recruitment Status : Completed
First Posted : December 18, 2007
Last Update Posted : March 13, 2012
Sponsor:
Collaborator:
Loders Croklaan
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
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 or disease Intervention/treatment Phase
Overweight Dietary Supplement: Conjugated linoleic acid Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of CLA Supplementation on Body Fat Accretion Among Children Who Are Overweight or at Risk of Overweight
Study Start Date : January 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. body composition using DXA [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. blood chemistry variables including fasting glucose and insulin, lipids, and liver enzymes [ Time Frame: 6 months ]


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Ages Eligible for Study:   6 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00575991     History of Changes
Other Study ID Numbers: H2006-0300
First Posted: December 18, 2007    Key Record Dates
Last Update Posted: March 13, 2012
Last Verified: March 2012

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

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms