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

Sponsor

University of Bergen (Other)

Overall Status

Completed

CT.gov ID

NCT02130908

Collaborator

Bergen Medical Research Foundation (Other), Skretting ASA (Other), Leroy Seafood Group ASA (Industry)

Enrollment

Location

Arms

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Disorders Obesity	Other: Lean fish Other: Fatty fish Other: Lean meat	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Other

Study Start Date :

Mar 1, 2011

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Jul 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Changes in metabolic parameters (lipids, glucose, inflammatory markers) measured in serum [Endpoint after 4 weeks intervention]

Secondary Outcome Measures

Changes in body weight [Endpoint after 4 weeks intervention]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

adults
non-obese
healthy

Exclusion Criteria:

diabetes
diagnosed diseases of the intestine or cardiovacular system

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Haukeland University Hospital	Bergen		Norway	5021

Sponsors and Collaborators

University of Bergen
Bergen Medical Research Foundation
Skretting ASA
Leroy Seafood Group ASA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Oddrun Anita Gudbrandsen, Researcher, University of Bergen

ClinicalTrials.gov Identifier:

NCT02130908

Other Study ID Numbers:

REK2011/572

First Posted:

May 6, 2014

Last Update Posted:

May 2, 2018

Last Verified:

May 1, 2018

Additional relevant MeSH terms:

Metabolic Diseases

Study Results

No Results Posted as of May 2, 2018