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CompletedNCT03538821COD2017Updated Jan 4, 2022

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.

An interventional study of Intact cod protein from fillet and Intact cod protein from residual material in Overweight and Obesity and Healthy, sponsored by University of Bergen. Completed at 1 site in Norway. Open to participants aged 20 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-04.

Sponsored by University of Bergen · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Jan 2017, registered May 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Overweight and Obesity
  • Healthy
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's planned enrollment of 100 is above the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

University of Bergen is the lead sponsor of 141 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 55 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • 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

  • 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

  • Experimental
    Control

    Control group receive tablet containing fillers and no proteins

    Dietary Supplement: Control

Interventions

  • Dietary supplementIntact cod protein from fillet

    Intact cod protein from fillet 8 g protein daily for 8 weeks

  • Dietary supplementIntact cod protein from residual material

    Intact cod protein from residual material, 8 g protein daily for 8 weeks

  • Dietary supplementControl

    Control group receive tablet containing fillers

06

What researchers measure

Primary outcomes

  1. Biomarkers related to lipid metabolism

    Lipids will be measured in fasting serum samples

    Time frame: 8 weeks

Secondary outcomes

  1. Biomarkers related to glucose regulation

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

    Time frame: 8 weeks

  2. Inflammatory markers

    Cytokines will be measured in fasting serum/plasma

    Time frame: 8 weeks

  3. Body composition

    Percent body fat will be measured using bioimpedance

    Time frame: 8 weeks

07

Study locations

1 site
  • Oddrun Anita Gudbrandsen
    Bergen, 5053, Norway
08

References and documents

Publications

  • Vikoren LA, Nygard OK, Lied E, Rostrup E, Gudbrandsen OA. A randomised study on the effects of fish protein supplement on glucose tolerance, lipids and body composition in overweight adults. Br J Nutr. 2013 Feb 28;109(4):648-57. doi: 10.1017/S0007114512001717. Epub 2012 May 31. PubMed 22647247 ↗
  • Drotningsvik A, Mjos SA, Pampanin DM, Slizyte R, Carvajal A, Remman T, Hogoy I, Gudbrandsen OA. Dietary fish protein hydrolysates containing bioactive motifs affect serum and adipose tissue fatty acid compositions, serum lipids, postprandial glucose regulation and growth in obese Zucker fa/fa rats. Br J Nutr. 2016 Oct;116(8):1336-1345. doi: 10.1017/S0007114516003548. Epub 2016 Oct 18. PubMed 27751188 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03538821
Lead sponsor
University of Bergen
Collaborators
The Research Council of Norway, K. Halstensen AS, Regional Research Fund Western Norway, Nofima
Responsible party
Oddrun Anita Gudbrandsen (Researcher, PhD, University of Bergen) — Principal investigator
First posted
May 29, 2018
Start date
Jan 2017
Primary completion
Dec 2019
Completion
Dec 2021
Last update
Jan 4, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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