Project Healthy Eating in Children. A Study on the Health Effects of Fish Intake in Overweight Children

May 22, 2016 updated by: Oddrun Anita Gudbrandsen, University of Bergen

Title in Norwegian: Ung og Frisk. En Studie av Helseeffekter av Fiskeinntak i Overvektige Barn.

It has previously been seen that increased fish intake improves the metabolic health of overweight and obese adults, and animal protein improved metabolic health of obese rats. In this project the investigators will investigate whether increased intake of fish or meat improve metabolic health in children aged 9-12 years as well when replacing processed food. The hypothesis is that increased intake of unprocessed fish or meat will improve metabolic health in children as measured by glucose tolerance, lipid metabolism and inflammatory markers.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bergen, Norway, 5021
        • University of Bergen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Cildren aged 9-12 years are invited to participate in the study. The children must be healthy and not use prescription medications that affects lipid metabolism, glucose regulation or the immunesystem.

Description

Inclusion Criteria:

  • overweight (iso-BMI > 25)
  • 9-12 years
  • healthy

Exclusion Criteria:

  • diagnosed diseases such as diabetes, CVD, intestinal diseases, arthritis
  • prescription medications affecting the metabolism of glucose, lipids or the immune system
  • use of supplements containing long chain n-3 fatty acids
  • high intake of fish
  • food allergy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Salmon Group
Participants will eat 75 - 150 grams of salmon for dinner, three times a week for 12 weeks.
The children are advised to eat at least 75g of salmon per serving, but no more than 150g
Cod Group
Participants will eat 75-150 grams of cod for dinner, three times a week for 12 weeks.
The children are advised to eat at least 75g of cod per serving, but no more than 150g
Meat Group
Participants will eat 75-150 grams of mixed meat for dinner, three times a week for 12 weeks.
The children are advised to eat at least 75g of meat per serving, but no more than 150g

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in metabolic status (glucose, lipids, inflammation)
Time Frame: Baseline and end of intervention period (12 weeks)
We will investigate any changes in the metabolic status by analyzing parameters affected by changes in glucose homeostasis, lipid metabolism and inflammation.
Baseline and end of intervention period (12 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Body composition
Time Frame: Baseline and end of intervention (12 weeks)
Baseline and end of intervention (12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Oddrun A Gudbrandsen, PhD, University of Bergen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

December 17, 2013

First Submitted That Met QC Criteria

December 30, 2013

First Posted (Estimate)

January 1, 2014

Study Record Updates

Last Update Posted (Estimate)

May 24, 2016

Last Update Submitted That Met QC Criteria

May 22, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/541

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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