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

June 26, 2009
September 25, 2012
November 2007
June 2008   (final data collection date for primary outcome measure)
Markers of the metabolic syndrome. Blood pressure, insulin sensitivity, HDL-cholesterol and triacylglycerol. [ Time Frame: Intervention period = 16 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00929552 on ClinicalTrials.gov Archive Site
Body composition [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Fish Oil on Markers of the Metabolic Syndrome in Overweight Adolescent Boys
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Metabolic Syndrome
Dietary Supplement: Dietary oils (fish, vegetable oil)
6g pr day.
  • 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.
    Intervention: Dietary Supplement: Dietary oils (fish, vegetable oil)
  • 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.
    Intervention: Dietary Supplement: Dietary oils (fish, vegetable oil)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
June 2009
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Smoking, severe illnesses.
Male
13 Years to 15 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00929552
D202, H-A-2007-0055
No
AAstrup, University of Copenhagen
University of Copenhagen
Not Provided
Principal Investigator: Lotte Lauritzen, Ph.D. University of Copenhagen
University of Copenhagen
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP