COD2017: 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.

Sponsor
University of Bergen (Other)
Overall Status
Completed
CT.gov ID
NCT03538821
Collaborator
The Research Council of Norway (Other), K. Halstensen AS (Other), Regional Research Fund Western Norway (Other), Nofima (Other)
100
1
3
59
1.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Intact cod protein from fillet
  • Dietary Supplement: Intact cod protein from residual material
  • Dietary Supplement: Control
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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.
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Dec 1, 2019
Actual Study Completion Date :
Dec 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Biomarkers related to lipid metabolism [8 weeks]

    Lipids will be measured in fasting serum samples

Secondary Outcome Measures

  1. Biomarkers related to glucose regulation [8 weeks]

    Glucose, insulin and GLP-1 and will be measured in serum/plasma sampled in fasting and postprandial conditions.

  2. Inflammatory markers [8 weeks]

    Cytokines will be measured in fasting serum/plasma

  3. Body composition [8 weeks]

    Percent body fat will be measured using bioimpedance

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Oddrun Anita Gudbrandsen Bergen Norway 5053

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Oddrun Anita Gudbrandsen, Researcher, PhD, University of Bergen
ClinicalTrials.gov Identifier:
NCT03538821
Other Study ID Numbers:
  • 2015/75 part 1
First Posted:
May 29, 2018
Last Update Posted:
Jan 4, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 4, 2022