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Effect of Conjugated Linoleic Acid on Body Fat in Overweight Children

Primary Purpose

Overweight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Conjugated linoleic acid
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring conjugated linoleic acid, body fat, children, overweight

Eligibility Criteria

6 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • medical condition
  • dairy allergy

Sites / Locations

  • University of Wisconsin Department of Nutritional Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

body composition using DXA

Secondary Outcome Measures

blood chemistry variables including fasting glucose and insulin, lipids, and liver enzymes

Full Information

First Posted
December 14, 2007
Last Updated
March 12, 2012
Sponsor
University of Wisconsin, Madison
Collaborators
Bunge Loders Croklaan
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1. Study Identification

Unique Protocol Identification Number
NCT00575991
Brief Title
Effect of Conjugated Linoleic Acid on Body Fat in Overweight Children
Official Title
Effect of CLA Supplementation on Body Fat Accretion Among Children Who Are Overweight or at Risk of Overweight
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Bunge Loders Croklaan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
conjugated linoleic acid, body fat, children, overweight

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Conjugated linoleic acid
Intervention Description
3 grams per day of 80% CLA in safflower oil (2.4 grams active CLA isomers in triglyceride form)
Primary Outcome Measure Information:
Title
body composition using DXA
Time Frame
6 months
Secondary Outcome Measure Information:
Title
blood chemistry variables including fasting glucose and insulin, lipids, and liver enzymes
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age 6 to 10 years body mass index greater than 85th percentile Tanner stage I Exclusion Criteria: medical condition dairy allergy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dale A Schoeller, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Department of Nutritional Sciences
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53706
Country
United States

12. IPD Sharing Statement

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Effect of Conjugated Linoleic Acid on Body Fat in Overweight Children

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