Effect of Conjugated Linoleic Acid on Body Fat in Overweight Children
This study has been completed.
Sponsor:
University of Wisconsin, Madison
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
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 14, 2007 | ||||
| Last Updated Date | March 12, 2012 | ||||
| Start Date ICMJE | January 2007 | ||||
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
body composition using DXA [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
body composition using the four-compartment model [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00575991 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
blood chemistry variables including fasting glucose and insulin, lipids, and liver enzymes [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Conjugated Linoleic Acid on Body Fat in Overweight Children | ||||
| Official Title ICMJE | Effect of CLA Supplementation on Body Fat Accretion Among Children Who Are Overweight or at Risk of Overweight | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Overweight | ||||
| Intervention ICMJE | Dietary Supplement: Conjugated linoleic acid
3 grams per day of 80% CLA in safflower oil (2.4 grams active CLA isomers in triglyceride form) |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 62 | ||||
| Completion Date | September 2008 | ||||
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 6 Years to 10 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00575991 | ||||
| Other Study ID Numbers ICMJE | H2006-0300 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | University of Wisconsin, Madison | ||||
| Study Sponsor ICMJE | University of Wisconsin, Madison | ||||
| Collaborators ICMJE | Loders Croklaan | ||||
| Investigators ICMJE |
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| Information Provided By | University of Wisconsin, Madison | ||||
| Verification Date | March 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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