A Study on the Possible Health Effects of Lean Fish, Fatty Fish and Lean Meat Intake in Non-obese Adults (FISK1)

May 1, 2018 updated by: Oddrun Anita Gudbrandsen, University of Bergen

This study is a pilot study to investigate whether intake of lean or fatty fish, or lean meat would affect parameters related to health in healthy non-obese adults, and will serve as basis for future calculation of group sizes in coming studies. Participants consumed 750g/week of fillets of fish or meat for 4 weeks.

Hypothesis:

High intake of either lean or fatty fish will not affect serum concentrations of lipids and inflammatory markers as well as improve glucose tolerance during the 4 week intervention period when compared to lean meat intake.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

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

  • Norway
      • Bergen, Norway, 5021
        • Haukeland University hospital

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 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adults
  • non-obese
  • healthy

Exclusion Criteria:

  • diabetes
  • diagnosed diseases of the intestine or cardiovacular system

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lean fish
Other: Lean fish
Participants consumed 150g of lean fish, five times per week for 4 weeks
Experimental: Fatty fish
Other: Fatty fish
Participants consumed 150g of fatty fish, five times per week for 4 weeks
Experimental: Lean meat
Other: Lean meat
Participants consumed 150g of lean meat, five times per week for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in metabolic parameters (lipids, glucose, inflammatory markers) measured in serum
Time Frame: Endpoint after 4 weeks intervention
Endpoint after 4 weeks intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in body weight
Time Frame: Endpoint after 4 weeks intervention
Endpoint after 4 weeks intervention

Collaborators and Investigators

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

Sponsor

University of Bergen

Collaborators

Bergen Medical Research Foundation
Skretting ASA
Leroy Seafood Group ASA

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

March 1, 2011

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

May 1, 2014

First Submitted That Met QC Criteria

May 5, 2014

First Posted (Estimate)

May 6, 2014

Study Record Updates

Last Update Posted (Actual)

May 2, 2018

Last Update Submitted That Met QC Criteria

May 1, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REK2011/572

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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