Back to resultsA Study of the Effects of Intake of Two Cod Residual Meals on Glucose Regulation in Overweight and Obese Adults (FISK4)
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Cod protein from presscake
Cod protein from presscake + stickwater
Control
Sponsored by
About this trial
This is an interventional treatment trial for Overweight
Eligibility Criteria
Inclusion Criteria:
- BMI>28
- healthy
- fasting blood glucose <7.0 mmol/L
- stable body weight with less than 5 kg fluctuation during the last 4 months
Exclusion Criteria:
- known disease or metabolic disturbances related to overweight or obesity
- use of prescription medications that affect blood glucose, blood lipids or inflammatory status
- allergies towards fish or seafood
- undertaking a weight loss diet
- tobacco use exceeding >15 cigarettes/day
- pregnancy or breastfeeding
- high seafood consumption
- use of dietary supplements including cod liver oil or other marine fatty acids
- allergies towards fish, milk, egg
Sites / Locations
- University of Bergen
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Cod protein from presscake
Cod protein from presscake + stickwater
Control
Arm Description
Control group will receive tablet containing only tablet fillers (the same as in the cod protein tablets).
Outcomes
Primary Outcome Measures
Glucose tolerance
Serum glucose will be measured in fasting and postprandial state
Secondary Outcome Measures
Gene expression
Changes in gene expression in adipose tissue related to the circulating markers of glucose regulation.
Amino acids and amino acid metabolites
Amino acids and amino acid metabolites will be measured in serum and urine
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
NCT01894542
First Posted
July 3, 2013
Last Updated
March 29, 2022
Sponsor
University of Bergen
Collaborators
Granit AS Transport & Tourism, Norwegian Seafood Center, Nofima
1. Study Identification
Unique Protocol Identification Number
NCT01894542
Brief Title
A Study of the Effects of Intake of Two Cod Residual Meals on Glucose Regulation in Overweight and Obese Adults
Acronym
FISK4
Official Title
An 8 Week Study to Compare the Effects of Two Combinations of Water Soluble and Non-water Soluble Cod Residual Meals 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
August 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bergen
Collaborators
Granit AS Transport & Tourism, Norwegian Seafood Center, Nofima
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators have previously shown the intact protein from cod filet improves glucose regulation and serum lipid profile in overweight adults. A large amount of trimmings from various fish species such as cod is thrown away or sold at very low prices for animal feed, and analyses of the amino acid composition reveals that this can be a good protein source for humans. Two fractions are normally isolated from intact fish meal, i.e. water soluble and non-water soluble proteins. In the present study the investigators will compare these fractions, by studying their effects on glucose regulation in overweight/obese adults.
Detailed Description
Participants receive 6g per day of water soluble on non-water soluble cod protein as tablets for 8 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cod protein from presscake
Arm Type
Experimental
Arm Title
Cod protein from presscake + stickwater
Arm Type
Experimental
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Control group will receive tablet containing only tablet fillers (the same as in the cod protein tablets).
Intervention Type
Dietary Supplement
Intervention Name(s)
Cod protein from presscake
Intervention Description
6g protein per day for 8wk
Intervention Type
Dietary Supplement
Intervention Name(s)
Cod protein from presscake + stickwater
Intervention Description
6 g protein per day for 8 wk
Intervention Type
Dietary Supplement
Intervention Name(s)
Control
Primary Outcome Measure Information:
Title
Glucose tolerance
Description
Serum glucose will be measured in fasting and postprandial state
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Gene expression
Description
Changes in gene expression in adipose tissue related to the circulating markers of glucose regulation.
Time Frame
8 weeks
Title
Amino acids and amino acid metabolites
Description
Amino acids and amino acid metabolites will be measured in serum and urine
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
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI>28
healthy
fasting blood glucose <7.0 mmol/L
stable body weight with less than 5 kg fluctuation during the last 4 months
Exclusion Criteria:
known disease or metabolic disturbances related to overweight or obesity
use of prescription medications that affect blood glucose, blood lipids or inflammatory status
allergies towards fish or seafood
undertaking a weight loss diet
tobacco use exceeding >15 cigarettes/day
pregnancy or breastfeeding
high seafood consumption
use of dietary supplements including cod liver oil or other marine fatty acids
allergies towards fish, milk, egg
Facility Information:
Facility Name
University of Bergen
City
Bergen
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
22647247
Citation
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.
Results Reference
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A Study of the Effects of Intake of Two Cod Residual Meals on Glucose Regulation in Overweight and Obese Adults
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