- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00929552
Effect of Fish Oil on Markers of the Metabolic Syndrome in Overweight Adolescent Boys (TeenFisk)
Effect of n-3 LCPUFAs on Weight Reduction and Metabolic Syndrome.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Frederiksberg, Denmark, 1958
- Department of Human Nutrition
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Weight above the 90th percentile for height and age.
Exclusion Criteria:
- Smoking, severe illnesses.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fish oil
Daily dose = 6g fish oil baked into rye bread and wheat rolls.
Participants were asked to consume two slices of rye bread and one wheat roll pr day.
The fish oil was micro-incapsulated.
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6g pr day.
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Active Comparator: Vegetable oil (Mix of canola, palm and soy oil)
Daily dose = 6g vegetable oil baked into rye bread and wheat rolls.
Participants were asked to consume two slices of rye bread and one wheat roll pr day.
|
6g pr day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Markers of the metabolic syndrome. Blood pressure, insulin sensitivity, HDL-cholesterol and triacylglycerol.
Time Frame: Intervention period = 16 weeks
|
Intervention period = 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Body composition
Time Frame: 16 weeks
|
16 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lotte Lauritzen, ph.d., University of Copenhagen
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D202
- H-A-2007-0055
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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