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

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ClinicalTrials.gov Identifier: NCT00929552
Recruitment Status : Completed
First Posted : June 29, 2009
Last Update Posted : September 26, 2012
Sponsor:
Information provided by (Responsible Party):
AAstrup, University of Copenhagen

Brief 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.


Condition or disease Intervention/treatment Phase
Metabolic Syndrome Dietary Supplement: Dietary oils (fish, vegetable oil) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of n-3 LCPUFAs on Weight Reduction and Metabolic Syndrome.
Study Start Date : November 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Fish oil

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

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




Primary Outcome Measures :
  1. Markers of the metabolic syndrome. Blood pressure, insulin sensitivity, HDL-cholesterol and triacylglycerol. [ Time Frame: Intervention period = 16 weeks ]

Secondary Outcome Measures :
  1. Body composition [ Time Frame: 16 weeks ]


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Ages Eligible for Study:   13 Years to 15 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Smoking, severe illnesses.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00929552


Locations
Denmark
Department of Human Nutrition
Frederiksberg, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
Investigators
Principal Investigator: Lotte Lauritzen, Ph.D. University of Copenhagen

Publications of Results:
Responsible Party: AAstrup, Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT00929552     History of Changes
Other Study ID Numbers: D202
H-A-2007-0055
First Posted: June 29, 2009    Key Record Dates
Last Update Posted: September 26, 2012
Last Verified: September 2012

Keywords provided by AAstrup, University of Copenhagen:
Blood pressure
Insulin sensitivity
Blood lipid profile

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases