Back to resultsA Study of the Effects of Fish Protein Intake on Glucose Regulation in Overweight and Obese Adults. (FISK3)
Primary Purpose
Obesity, Overweight
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Salmon protein hydrolysate
Herring protein hydrolysate
Cod protein
Milk protein
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
Inclusion Criteria:
- BMI above 27 kg/m2
- healthy
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
Sites / Locations
- Institute of Medicine, University of Bergen
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Sham Comparator
Placebo Comparator
Arm Label
Salmon protein hydrolysate
Herring protein hydrolysate
Cod protein
Milk protein
Arm Description
Outcomes
Primary Outcome Measures
Glucose regulation
Glucose will be measured in fasting and postprandial samples
Secondary Outcome Measures
Changes in serum insulin, insulin C-peptide, non-esterified fatty acids, lipids, adiponectin, leptin and fatty acid composition
Changes in serum and urine concentrations of amino acids and their metabolites
Changes in serum concentrations of vitamins
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
Full Information
NCT ID
NCT01641055
First Posted
July 12, 2012
Last Updated
March 29, 2022
Sponsor
University of Bergen
Collaborators
BlueProtein, NutriMar
1. Study Identification
Unique Protocol Identification Number
NCT01641055
Brief Title
A Study of the Effects of Fish Protein Intake on Glucose Regulation in Overweight and Obese Adults.
Acronym
FISK3
Official Title
A 8 wk Study to Compare the Effects of Proteins Various Fish Species (Salmon, Herring, Cod) and Milk on Glucose Regulation in Overweight and Obese Adults.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bergen
Collaborators
BlueProtein, NutriMar
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Participants receive 2.5g protein per day for 8 weeks as tablets.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Salmon protein hydrolysate
Arm Type
Experimental
Arm Title
Herring protein hydrolysate
Arm Type
Experimental
Arm Title
Cod protein
Arm Type
Sham Comparator
Arm Title
Milk protein
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Salmon protein hydrolysate
Intervention Description
2.5g salmon protein hydrolysate per day for 8wk.
Intervention Type
Dietary Supplement
Intervention Name(s)
Herring protein hydrolysate
Intervention Description
2.5g herring protein hydrolysate per day for 8wk.
Intervention Type
Dietary Supplement
Intervention Name(s)
Cod protein
Intervention Description
2.5g cod protein per day for 8wk.
Intervention Type
Dietary Supplement
Intervention Name(s)
Milk protein
Intervention Description
2.5g milk protein per day for 8wk.
Primary Outcome Measure Information:
Title
Glucose regulation
Description
Glucose will be measured in fasting and postprandial samples
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Changes in serum insulin, insulin C-peptide, non-esterified fatty acids, lipids, adiponectin, leptin and fatty acid composition
Time Frame
8 weeks
Title
Changes in serum and urine concentrations of amino acids and their metabolites
Time Frame
8 weeks
Title
Changes in serum concentrations of vitamins
Time Frame
8 weeks
Title
Comparisons of metabolites and co-factors involved in one-carbon metabolism in serum and urine
Description
Concentrations of relevant metabolites and co-factors were measured in serum and urine
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI above 27 kg/m2
healthy
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oddrun A Gudbrandsen, PhD
Organizational Affiliation
University of Bergen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Medicine, University of Bergen
City
Bergen
ZIP/Postal Code
5021
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
30972484
Citation
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.
Results Reference
derived
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A Study of the Effects of Fish Protein Intake on Glucose Regulation in Overweight and Obese Adults.
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