NCT01641055

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jul 2012

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 16, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

April 7, 2022

Status Verified

March 1, 2022

Enrollment Period

4 months

First QC Date

July 12, 2012

Last Update Submit

March 29, 2022

Conditions

ObesityOverweight

Outcome Measures

Primary Outcomes (1)

  • Glucose regulation

    Glucose will be measured in fasting and postprandial samples

    8 weeks

Secondary Outcomes (4)

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

    8 weeks

  • Changes in serum and urine concentrations of amino acids and their metabolites

    8 weeks

  • Changes in serum concentrations of vitamins

    8 weeks

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

    8 weeks

Study Arms (4)

Salmon protein hydrolysate

EXPERIMENTAL
Dietary Supplement: Salmon protein hydrolysate

Herring protein hydrolysate

EXPERIMENTAL
Dietary Supplement: Herring protein hydrolysate

Cod protein

SHAM COMPARATOR
Dietary Supplement: Cod protein

Milk protein

PLACEBO COMPARATOR
Dietary Supplement: Milk protein

Interventions

Salmon protein hydrolysateDIETARY_SUPPLEMENT

2.5g salmon protein hydrolysate per day for 8wk.

Salmon protein hydrolysate
Herring protein hydrolysateDIETARY_SUPPLEMENT

2.5g herring protein hydrolysate per day for 8wk.

Herring protein hydrolysate
Cod proteinDIETARY_SUPPLEMENT

2.5g cod protein per day for 8wk.

Cod protein
Milk proteinDIETARY_SUPPLEMENT

2.5g milk protein per day for 8wk.

Milk protein

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI above 27 kg/m2
  • healthy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Medicine, University of Bergen

Bergen, 5021, Norway

Location

Related Publications (1)

  • 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.

    PMID: 30972484DERIVED

MeSH Terms

Conditions

ObesityOverweight

Interventions

Allergen M protein, codfishMilk Proteins

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Animal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsFoodDiet, Food, and NutritionPhysiological PhenomenaMilkDairy ProductsFood and Beverages

Study Officials

  • Oddrun A Gudbrandsen, PhD

    University of Bergen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 12, 2012

First Posted

July 16, 2012

Study Start

July 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

April 7, 2022

Record last verified: 2022-03

Locations

NO(1)