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CompletedNCT01641055FISK3Updated Apr 7, 2022

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

An interventional study of Salmon protein hydrolysate and Herring protein hydrolysate in Obesity and Overweight, sponsored by University of Bergen. Completed at 1 site in Norway. Open to participants aged 18 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-07.

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

Phase
Not applicable
Study type
Interventional
Enrollment
93
Allocation
Randomized
Ages
18 Years to 69 Years
Sex
All
01

Study summary

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.

Read the detailed description

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

02

Conditions studied

  • Obesity
  • Overweight

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03

In context

Overweight

3,671 studies on the registry are indexed under Overweight; 850 are open to participants now.

This study's enrollment of 93 is above the median of 74 across 3,176 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
18 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • BMI above 27 kg/m2
  • healthy

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Double (Participant, Investigator)
Enrollment
93 participants (actual)

Study arms

  • Experimental
    Salmon protein hydrolysate

    Dietary Supplement: Salmon protein hydrolysate

  • Experimental
    Herring protein hydrolysate

    Dietary Supplement: Herring protein hydrolysate

  • Sham comparator
    Cod protein

    Dietary Supplement: Cod protein

  • Placebo comparator
    Milk protein

    Dietary Supplement: Milk protein

Interventions

  • Dietary supplementSalmon protein hydrolysate

    2.5g salmon protein hydrolysate per day for 8wk.

  • Dietary supplementHerring protein hydrolysate

    2.5g herring protein hydrolysate per day for 8wk.

  • Dietary supplementCod protein

    2.5g cod protein per day for 8wk.

  • Dietary supplementMilk protein

    2.5g milk protein per day for 8wk.

06

What researchers measure

Primary outcomes

  1. Glucose regulation

    Glucose will be measured in fasting and postprandial samples

    Time frame: 8 weeks

Secondary outcomes

  1. Changes in serum insulin, insulin C-peptide, non-esterified fatty acids, lipids, adiponectin, leptin and fatty acid composition

    Time frame: 8 weeks

  2. Changes in serum and urine concentrations of amino acids and their metabolites

    Time frame: 8 weeks

  3. Changes in serum concentrations of vitamins

    Time frame: 8 weeks

  4. Comparisons of metabolites and co-factors involved in one-carbon metabolism in serum and urine

    Concentrations of relevant metabolites and co-factors were measured in serum and urine

    Time frame: 8 weeks

07

Study locations

1 site
  • Institute of Medicine, University of Bergen
    Bergen, 5021, Norway
08

References and documents

Publications

  • Hovland IH, Leikanger IS, Stokkeland O, Waage KH, Mjos SA, Brokstad KA, McCann A, Ueland PM, Slizyte R, Carvajal A, Mellgren G, Remman T, Hogoy I, Gudbrandsen OA. Effects of low doses of fish and milk proteins on glucose regulation and markers of insulin sensitivity in overweight adults: a randomised, double blind study. Eur J Nutr. 2020 Apr;59(3):1013-1029. doi: 10.1007/s00394-019-01963-0. Epub 2019 Apr 10. PubMed 30972484 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01641055
Lead sponsor
University of Bergen
Collaborators
BlueProtein, NutriMar
Responsible party
Oddrun Anita Gudbrandsen (PhD, University of Bergen) — Principal investigator
First posted
Jul 16, 2012
Start date
Jul 2012
Primary completion
Nov 2012
Completion
Nov 2012
Last update
Apr 7, 2022

Study contacts

Oddrun A Gudbrandsen, PhD
principal investigator · University of Bergen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

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