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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

Tracking Information
First Submitted Date  ICMJE June 26, 2009
First Posted Date  ICMJE June 29, 2009
Last Update Posted Date September 26, 2012
Study Start Date  ICMJE November 2007
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2009)
Markers of the metabolic syndrome. Blood pressure, insulin sensitivity, HDL-cholesterol and triacylglycerol. [ Time Frame: Intervention period = 16 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00929552 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2009)
Body composition [ Time Frame: 16 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Fish Oil on Markers of the Metabolic Syndrome in Overweight Adolescent Boys
Official Title  ICMJE Effect of n-3 LCPUFAs on Weight Reduction and Metabolic Syndrome.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Metabolic Syndrome
Intervention  ICMJE Dietary Supplement: Dietary oils (fish, vegetable oil)
6g pr day.
Study Arms
  • 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)
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 26, 2009)
78
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date June 2009
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Smoking, severe illnesses.
Sex/Gender
Sexes Eligible for Study: Male
Ages 13 Years to 15 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00929552
Other Study ID Numbers  ICMJE D202
H-A-2007-0055
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party AAstrup, University of Copenhagen
Study Sponsor  ICMJE University of Copenhagen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lotte Lauritzen, Ph.D. University of Copenhagen
PRS Account University of Copenhagen
Verification Date September 2012

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