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Project Healthy Eating in Adults. A Study on the Health Effects of Fish Intake in Overweight Adults (FINS)

Primary Purpose

Overweight or Obese Adults, Healthy

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Salmon Group
Cod Group
Meat Group
Sponsored by
University of Bergen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight or Obese Adults

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Bergen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Salmon Group

Cod Group

Meat Group

Arm Description

Participants will eat 150g salmon for dinner, 3 times per week for 12 weeks

Participants will eat 150g cod for dinner, 3 times per week for 12 weeks

Participants will eat 150g mixed meat for dinner, 3 times per week for 12 weeks

Outcomes

Primary Outcome Measures

Changes in metabolic status (glucose, lipids, inflammation)
The effects of fish intake on glucose homeostasis, lipid metabolism and inflammation will be assessed.

Secondary Outcome Measures

Changes in plasma concentrations of amino acids and their metabolites
Changes in plasma concentrations of vitamins

Full Information

First Posted
December 17, 2013
Last Updated
April 27, 2021
Sponsor
University of Bergen
Collaborators
The Fisheries and Aquaculture Industry Research Fund
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1. Study Identification

Unique Protocol Identification Number
NCT02025920
Brief Title
Project Healthy Eating in Adults. A Study on the Health Effects of Fish Intake in Overweight Adults (FINS)
Official Title
Title in Norwegian: Sunn og Frisk. En Studie av Helseeffekter av Fiskeinntak i Overvektige Voksne (FINS)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bergen
Collaborators
The Fisheries and Aquaculture Industry Research Fund

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight or Obese Adults, Healthy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
183 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Salmon Group
Arm Type
Experimental
Arm Description
Participants will eat 150g salmon for dinner, 3 times per week for 12 weeks
Arm Title
Cod Group
Arm Type
Experimental
Arm Description
Participants will eat 150g cod for dinner, 3 times per week for 12 weeks
Arm Title
Meat Group
Arm Type
Active Comparator
Arm Description
Participants will eat 150g mixed meat for dinner, 3 times per week for 12 weeks
Intervention Type
Other
Intervention Name(s)
Salmon Group
Intervention Type
Other
Intervention Name(s)
Cod Group
Intervention Type
Other
Intervention Name(s)
Meat Group
Primary Outcome Measure Information:
Title
Changes in metabolic status (glucose, lipids, inflammation)
Description
The effects of fish intake on glucose homeostasis, lipid metabolism and inflammation will be assessed.
Time Frame
Baseline and end of intervention (12 weeks)
Secondary Outcome Measure Information:
Title
Changes in plasma concentrations of amino acids and their metabolites
Time Frame
Baseline and end of intervention (12 weeks)
Title
Changes in plasma concentrations of vitamins
Time Frame
Baseline and end of intervention (12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oddrun A Gudbrandsen, PhD
Organizational Affiliation
University of Bergen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Bergen
City
Bergen
Country
Norway

12. IPD Sharing Statement

Learn more about this trial

Project Healthy Eating in Adults. A Study on the Health Effects of Fish Intake in Overweight Adults (FINS)

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