- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02025920
Project Healthy Eating in Adults. A Study on the Health Effects of Fish Intake in Overweight Adults (FINS)
April 27, 2021 updated by: Oddrun Anita Gudbrandsen, University of Bergen
Title in Norwegian: Sunn og Frisk. En Studie av Helseeffekter av Fiskeinntak i Overvektige Voksne (FINS)
It has previously been observed 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 improves metabolic health in overweight/obese adults aged 20-55 years when replacing processed food.
The hypothesis is that increased intake of unprocessed fish or meat will improve metabolic health in adults as measured by glucose tolerance, lipid metabolism and inflammatory markers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
183
Phase
- Not Applicable
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
- 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
20 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BMI > 27
- 20-55 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
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Salmon Group
Participants will eat 150g salmon for dinner, 3 times per week for 12 weeks
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Experimental: Cod Group
Participants will eat 150g cod for dinner, 3 times per week for 12 weeks
|
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Active Comparator: Meat Group
Participants will eat 150g mixed meat for dinner, 3 times per week for 12 weeks
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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 (12 weeks)
|
The effects of fish intake on glucose homeostasis, lipid metabolism and inflammation will be assessed.
|
Baseline and end of intervention (12 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in plasma concentrations of amino acids and their metabolites
Time Frame: Baseline and end of intervention (12 weeks)
|
Baseline and end of intervention (12 weeks)
|
Changes in plasma concentrations of vitamins
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
January 1, 2014
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
December 1, 2019
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 (Actual)
April 30, 2021
Last Update Submitted That Met QC Criteria
April 27, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013/558
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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