Back to resultsThe Effects of Intake of Protein From Cod Fillet and Cod Residual Material on Lipid Regulation, Glucose Regulation and Inflammation in Overweight or Obese Adults. (COD2017)
Primary Purpose
Overweight and Obesity, Healthy
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Intact cod protein from fillet
Intact cod protein from residual material
Control
Sponsored by
About this trial
This is an interventional treatment trial for Overweight and Obesity
Eligibility Criteria
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:
- 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
Sites / Locations
- Oddrun Anita Gudbrandsen
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Intact cod protein from fillet
Intact cod protein from residual material
Control
Arm Description
Dietary supplement: intact cod protein from fillet, 8 g protein daily for 8 weeks
Dietary supplement: intact cod protein from residual material, 8 g protein daily for 8 weeks
Control group receive tablet containing fillers and no proteins
Outcomes
Primary Outcome Measures
Biomarkers related to lipid metabolism
Lipids will be measured in fasting serum samples
Secondary Outcome Measures
Biomarkers related to glucose regulation
Glucose, insulin and GLP-1 and will be measured in serum/plasma sampled in fasting and postprandial conditions.
Inflammatory markers
Cytokines will be measured in fasting serum/plasma
Body composition
Percent body fat will be measured using bioimpedance
Full Information
NCT ID
NCT03538821
First Posted
May 14, 2018
Last Updated
January 3, 2022
Sponsor
University of Bergen
Collaborators
The Research Council of Norway, K. Halstensen AS, Regional Research Fund Western Norway, Nofima
1. Study Identification
Unique Protocol Identification Number
NCT03538821
Brief Title
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.
Acronym
COD2017
Official Title
The Effects of a Daily Intake of Protein From Cod Fillet and Cod Residual Material for 8 Weeks on Serum Lipids and Fatty Acids, Glucose Regulation and Inflammation Markers in Overweight or Obese Adults: A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bergen
Collaborators
The Research Council of Norway, K. Halstensen AS, Regional Research Fund Western Norway, Nofima
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Healthy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intact cod protein from fillet
Arm Type
Experimental
Arm Description
Dietary supplement: intact cod protein from fillet, 8 g protein daily for 8 weeks
Arm Title
Intact cod protein from residual material
Arm Type
Experimental
Arm Description
Dietary supplement: intact cod protein from residual material, 8 g protein daily for 8 weeks
Arm Title
Control
Arm Type
Experimental
Arm Description
Control group receive tablet containing fillers and no proteins
Intervention Type
Dietary Supplement
Intervention Name(s)
Intact cod protein from fillet
Intervention Description
Intact cod protein from fillet 8 g protein daily for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Intact cod protein from residual material
Intervention Description
Intact cod protein from residual material, 8 g protein daily for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Control
Intervention Description
Control group receive tablet containing fillers
Primary Outcome Measure Information:
Title
Biomarkers related to lipid metabolism
Description
Lipids will be measured in fasting serum samples
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Biomarkers related to glucose regulation
Description
Glucose, insulin and GLP-1 and will be measured in serum/plasma sampled in fasting and postprandial conditions.
Time Frame
8 weeks
Title
Inflammatory markers
Description
Cytokines will be measured in fasting serum/plasma
Time Frame
8 weeks
Title
Body composition
Description
Percent body fat will be measured using bioimpedance
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
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
Facility Information:
Facility Name
Oddrun Anita Gudbrandsen
City
Bergen
ZIP/Postal Code
5053
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
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
background
PubMed Identifier
27751188
Citation
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.
Results Reference
background
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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.
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