- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02025933
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
Intervention / Treatment
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
-
-
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Bergen, Norway, 5021
- University of Bergen
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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.
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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)
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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.
Sponsor
Collaborators
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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