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

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Dietary oils (fish, vegetable oil)
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome focused on measuring Blood pressure, Insulin sensitivity, Blood lipid profile

Eligibility Criteria

13 Years - 15 Years (Child)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Smoking, severe illnesses.

Sites / Locations

  • Department of Human Nutrition

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fish oil

Vegetable oil (Mix of canola, palm and soy oil)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Markers of the metabolic syndrome. Blood pressure, insulin sensitivity, HDL-cholesterol and triacylglycerol.

Secondary Outcome Measures

Body composition

Full Information

First Posted
June 26, 2009
Last Updated
September 25, 2012
Sponsor
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT00929552
Brief Title
Effect of Fish Oil on Markers of the Metabolic Syndrome in Overweight Adolescent Boys
Acronym
TeenFisk
Official Title
Effect of n-3 LCPUFAs on Weight Reduction and Metabolic Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Blood pressure, Insulin sensitivity, Blood lipid profile

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fish oil
Arm Type
Experimental
Arm Description
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.
Arm Title
Vegetable oil (Mix of canola, palm and soy oil)
Arm Type
Active Comparator
Arm Description
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 Type
Dietary Supplement
Intervention Name(s)
Dietary oils (fish, vegetable oil)
Intervention Description
6g pr day.
Primary Outcome Measure Information:
Title
Markers of the metabolic syndrome. Blood pressure, insulin sensitivity, HDL-cholesterol and triacylglycerol.
Time Frame
Intervention period = 16 weeks
Secondary Outcome Measure Information:
Title
Body composition
Time Frame
16 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Weight above the 90th percentile for height and age. Exclusion Criteria: Smoking, severe illnesses.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lotte Lauritzen, Ph.D.
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Human Nutrition
City
Frederiksberg
ZIP/Postal Code
1958
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
20472253
Citation
Pedersen MH, Molgaard 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.
Results Reference
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Effect of Fish Oil on Markers of the Metabolic Syndrome in Overweight Adolescent Boys

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