A Study of the Effects of Fish Protein Intake on Glucose Regulation in Overweight and Obese Adults. (FISK3)

March 29, 2022 updated by: Oddrun Anita Gudbrandsen, University of Bergen

A 8 wk Study to Compare the Effects of Proteins Various Fish Species (Salmon, Herring, Cod) and Milk on Glucose Regulation in Overweight and Obese Adults.

The purpose of this study is to compare the possible health benefits of intake of proteins from salmon, herring, cod and milk on glucose tolerance in overweight and obese adults. Overweight and obese subjects often have reduced glucose tolerance, and previous findings from a study on cod proteins suggested that glucose tolerance was improved.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants receive 2.5g protein per day for 8 weeks as tablets.

Study Type

Interventional

Enrollment (Actual)

93

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
        • Institute of Medicine, University of Bergen

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

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI above 27 kg/m2
  • healthy

Exclusion Criteria:

  • fasting blood glucose above 7 mM
  • medication that affects blood glucose, lipids and inflammatory status
  • pregnancy or breastfeeding
  • allergies to fish or milk
  • intentional weight loss and large fluctuation in body weight
  • a high consumption of fish
  • an extreme diet
  • use of fish oil, n-3 or multivitamin supplements

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Milk protein
Dietary supplement: Milk protein
2.5g milk protein per day for 8wk.
Experimental: Salmon protein hydrolysate
Dietary supplement: Salmon protein hydrolysate
2.5g salmon protein hydrolysate per day for 8wk.
Experimental: Herring protein hydrolysate
Dietary supplement: Herring protein hydrolysate
2.5g herring protein hydrolysate per day for 8wk.
Sham Comparator: Cod protein
Dietary supplement: Cod protein
2.5g cod protein per day for 8wk.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose regulation
Time Frame: 8 weeks
Glucose will be measured in fasting and postprandial samples
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in serum insulin, insulin C-peptide, non-esterified fatty acids, lipids, adiponectin, leptin and fatty acid composition
Time Frame: 8 weeks
8 weeks
Changes in serum and urine concentrations of amino acids and their metabolites
Time Frame: 8 weeks
8 weeks
Changes in serum concentrations of vitamins
Time Frame: 8 weeks
8 weeks
Comparisons of metabolites and co-factors involved in one-carbon metabolism in serum and urine
Time Frame: 8 weeks
Concentrations of relevant metabolites and co-factors were measured in serum and urine
8 weeks

Collaborators and Investigators

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

Sponsor

University of Bergen

Collaborators

BlueProtein
NutriMar

Investigators

  • Principal Investigator: Oddrun A Gudbrandsen, PhD, University of Bergen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2012

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

July 12, 2012

First Submitted That Met QC Criteria

July 12, 2012

First Posted (Estimate)

July 16, 2012

Study Record Updates

Last Update Posted (Actual)

April 7, 2022

Last Update Submitted That Met QC Criteria

March 29, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/572

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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