NCT00575991

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 18, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

March 13, 2012

Status Verified

March 1, 2012

Enrollment Period

1.4 years

First QC Date

December 14, 2007

Last Update Submit

March 12, 2012

Conditions

Overweight

Keywords

conjugated linoleic acid, body fat, children, overweight

Outcome Measures

Primary Outcomes (1)

  • body composition using DXA

    6 months

Secondary Outcomes (1)

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

    6 months

Study Arms (2)

A

EXPERIMENTAL
Dietary Supplement: Conjugated linoleic acid

B

PLACEBO COMPARATOR
Dietary Supplement: Conjugated linoleic acid

Interventions

Conjugated linoleic acidDIETARY_SUPPLEMENT

3 grams per day of 80% CLA in safflower oil (2.4 grams active CLA isomers in triglyceride form)

AB

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • medical condition
  • dairy allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin Department of Nutritional Sciences

Madison, Wisconsin, 53706, United States

Location

MeSH Terms

Conditions

Overweight

Interventions

Linoleic Acids, Conjugated

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Linoleic AcidsFatty Acids, Omega-6Fatty Acids, UnsaturatedFatty AcidsLipids

Study Officials

  • Dale A Schoeller, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2007

First Posted

December 18, 2007

Study Start

January 1, 2007

Primary Completion

June 1, 2008

Study Completion

September 1, 2008

Last Updated

March 13, 2012

Record last verified: 2012-03

Locations

US(1)