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NCT00929552 Clinical Trial

Effect of Fish Oil on Markers of the Metabolic Syndrome in Overweight Adolescent Boys

Metabolic Syndrome Clinical Trial

— TeenFisk  

Official title:
Effect of n-3 LCPUFAs on Weight Reduction and Metabolic Syndrome.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00929552
Other study ID # D202
Secondary ID H-A-2007-0055
Status Completed
Phase N/A
First received June 26, 2009
Last updated September 25, 2012
Start date November 2007
Est. completion date June 2009

Study information
Verified date September 2012
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority Denmark: The Danish National Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial Summary

The aim of the study is to investigate if dietary fish oil has a beneficial effect on blood pressure, insulin sensitivity, blood lipid profile, body composition and metabolic rate in healthy, but slightly overweight, teenage boys.

We hypothesized that the n-3 long chain polyunsaturated fatty acids from fish oil might have greater effect during growth and development, as intervention trials studying the effect of fish oil on babies have shown greater effects than in adults.

Recruitment information / eligibility
Status Completed
Enrollment 78
Est. completion date June 2009
Est. primary completion date June 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 13 Years to 15 Years
Eligibility Inclusion Criteria:

- Weight above the 90th percentile for height and age.

Exclusion Criteria:

- Smoking, severe illnesses.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Dietary oils (fish, vegetable oil)
6g pr day.

Locations
Country Name City State
Denmark Department of Human Nutrition Frederiksberg

Sponsors (1)
Lead Sponsor Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Pedersen MH, Mølgaard C, Hellgren LI, Lauritzen L. Effects of fish oil supplementation on markers of the metabolic syndrome. J Pediatr. 2010 Sep;157(3):395-400, 400.e1. doi: 10.1016/j.jpeds.2010.04.001. Epub 2010 May 15. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Markers of the metabolic syndrome. Blood pressure, insulin sensitivity, HDL-cholesterol and triacylglycerol. Intervention period = 16 weeks No
Secondary Body composition 16 weeks No
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