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

NCT ID: NCT00929552

Last Updated: 2012-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-06-30

Brief Summary

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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

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Conditions

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Metabolic Syndrome

Keywords

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Blood pressure Insulin sensitivity Blood lipid profile

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Dietary oils (fish, vegetable oil)

Intervention Type DIETARY_SUPPLEMENT

6g pr day.

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.

Group Type ACTIVE_COMPARATOR

Dietary oils (fish, vegetable oil)

Intervention Type DIETARY_SUPPLEMENT

6g pr day.

Interventions

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Dietary oils (fish, vegetable oil)

6g pr day.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Smoking, severe illnesses.
Minimum Eligible Age

13 Years

Maximum Eligible Age

15 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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AAstrup

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lotte Lauritzen, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

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Department of Human Nutrition

Frederiksberg, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type RESULT
PMID: 20472253 (View on PubMed)

Other Identifiers

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H-A-2007-0055

Identifier Type: -

Identifier Source: secondary_id

D202

Identifier Type: -

Identifier Source: org_study_id