The Effects of Intake of Protein From Cod Fillet and Cod Residual Material on Lipid Regulation, Glucose Regulation and Inflammation in Overweight or Obese Adults. (COD2017)

January 3, 2022 updated by: Oddrun Anita Gudbrandsen, University of Bergen

The Effects of a Daily Intake of Protein From Cod Fillet and Cod Residual Material for 8 Weeks on Serum Lipids and Fatty Acids, Glucose Regulation and Inflammation Markers in Overweight or Obese Adults: A Randomized Controlled Trial.

A high intake of fish is associated with positive health effects, including prevention and treatment of chronic non-communicable diseases, such as cardiovascular diseases (CVDs) and type 2 diabetes. These health effects have traditionally been attributed to the omega-3 fatty acids in fatty fish, but recent studies have suggested that also fish proteins may improve biomarkers of metabolic disease. Intake of cod fillet have previously shown beneficial effects on blood lipids, glucose regulation and body composition in adults with overweight or obesity. Health effect of cod residual material from fillet production (i.e., head, backbone, skin, cutoffs and entrails) have so far not been investigated, but residuals from other fish species have shown promising effects on glucose regulation in rats. The main aim of the current study is to investigate the effects of protein from cod fillet and cod residuals on serum lipids, glucose regulation and inflammatory markers in healthy overweight or obese adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

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, 5053
        • Oddrun Anita Gudbrandsen

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI ≥ 27 kg/m2
  • Fasting blood glucose ≤7 mmol/L
  • Physically inactive
  • Percent body fat > 25 % for men and > 35 % for women

Exclusion Criteria:

  • Allergies towards fish, milk, egg, gluten
  • Tobacco use > 10 cigarettes (or snus) per day
  • Diseases affecting the heart, intestinal function, kidney function or insulin secretion
  • Medications targeting cholesterol -or glucose metabolism, hypertension
  • Use of dietary supplements
  • Pregnancy or lactation

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: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intact cod protein from fillet
Dietary supplement: intact cod protein from fillet, 8 g protein daily for 8 weeks
Dietary supplement: Intact cod protein from fillet
Intact cod protein from fillet 8 g protein daily for 8 weeks
Experimental: Intact cod protein from residual material
Dietary supplement: intact cod protein from residual material, 8 g protein daily for 8 weeks
Dietary supplement: Intact cod protein from residual material
Intact cod protein from residual material, 8 g protein daily for 8 weeks
Experimental: Control
Control group receive tablet containing fillers and no proteins
Dietary supplement: Control
Control group receive tablet containing fillers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarkers related to lipid metabolism
Time Frame: 8 weeks
Lipids will be measured in fasting serum samples
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarkers related to glucose regulation
Time Frame: 8 weeks
Glucose, insulin and GLP-1 and will be measured in serum/plasma sampled in fasting and postprandial conditions.
8 weeks
Inflammatory markers
Time Frame: 8 weeks
Cytokines will be measured in fasting serum/plasma
8 weeks
Body composition
Time Frame: 8 weeks
Percent body fat will be measured using bioimpedance
8 weeks

Collaborators and Investigators

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

Sponsor

University of Bergen

Collaborators

The Research Council of Norway
Nofima
K. Halstensen AS
Regional Research Fund Western Norway

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 (Actual)

January 1, 2017

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

May 14, 2018

First Submitted That Met QC Criteria

May 24, 2018

First Posted (Actual)

May 29, 2018

Study Record Updates

Last Update Posted (Actual)

January 4, 2022

Last Update Submitted That Met QC Criteria

January 3, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/75 part 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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