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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AAstrup, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00929552
First received: June 26, 2009
Last updated: September 25, 2012
Last verified: September 2012
  Purpose

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 Intervention
Metabolic Syndrome
Dietary Supplement: Dietary oils (fish, vegetable oil)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of n-3 LCPUFAs on Weight Reduction and Metabolic Syndrome.

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Markers of the metabolic syndrome. Blood pressure, insulin sensitivity, HDL-cholesterol and triacylglycerol. [ Time Frame: Intervention period = 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body composition [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 78
Study Start Date: November 2007
Study Completion Date: June 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   13 Years to 15 Years
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: AAstrup, Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT00929552     History of Changes
Other Study ID Numbers: D202, H-A-2007-0055
Study First Received: June 26, 2009
Last Updated: September 25, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

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

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

ClinicalTrials.gov processed this record on April 17, 2014