Effect of Conjugated Linoleic Acid on Body Fat in Overwei... | NCT00575991

Studies
Effect of Conjugated Linoleic Acid on Body Fat in Overweight Children

NCT00575991

Sponsor

University of Wisconsin, Madison

Status

Completed

Last Update Posted

Mar 13, 2012Estimated

Enrollment

62Actual

Phase

Not Applicable

Conditions

Overweight

Interventions

Conjugated linoleic acid

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Jun 2008Actual

Completion Date

Sep 2008Actual

First Submitted Date

Dec 14, 2007

First Submission Date that Met QC Criteria

Dec 14, 2007

First Posted Date

Dec 18, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2012

Last Update Posted Date

Mar 13, 2012Estimated

Name	Class
Bunge Loders Croklaan	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental		Dietary Supplement: Conjugated linoleic acid
B	Placebo Comparator		Dietary Supplement: Conjugated linoleic acid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Conjugated linoleic acid	Dietary Supplement	3 grams per day of 80% CLA in safflower oil (2.4 grams active CLA isomers in triglyceride form)	A B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
body composition using DXA		6 months

Secondary Outcomes

Measure	Description	Time Frame
blood chemistry variables including fasting glucose and insulin, lipids, and liver enzymes		6 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dale A Schoeller, PhD	University of Wisconsin, Madison	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Wisconsin Department of Nutritional Sciences		Madison	Wisconsin	53706	United States

Condition Browse Module

MeSH Terms

ID	Term
D050177	Overweight

Ancestor Terms

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D044243	Linoleic Acids, Conjugated

Ancestor Terms

ID	Term
D008041	Linoleic Acids
D043371	Fatty Acids, Omega-6
D005231	Fatty Acids, Unsaturated
D005227	Fatty Acids

Browse Leaves

Not provided

Browse Branches

Not provided