Overweight and ObesityCOD2017NCT03538821
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.
A study testing Intact cod protein from fillet and Intact cod protein from residual material in people with Overweight and Obesity and Healthy, run by University of Bergen at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Healthy
- What is being tested?
- Intact cod protein from fillet and Intact cod protein from residual material
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2017to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI ≥ 27 kg/m2
- Fasting blood glucose ≤7 mmol/L
- Physically inactive
- Percent body fat > 25 % for men and > 35 % for women
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Overweight and Obesity, Healthy
- Being tested
- Intact cod protein from fillet, Intact cod protein from residual material, Control
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intact cod protein from filletDietary supplement
Intact cod protein from fillet 8 g protein daily for 8 weeks
Intact cod protein from residual materialDietary supplement
Intact cod protein from residual material, 8 g protein daily for 8 weeks
ControlDietary supplement
Control group receive tablet containing fillers
| Study group | Role | What they receive |
|---|---|---|
| Intact cod protein from fillet | Experimental | Dietary supplement: intact cod protein from fillet, 8 g protein daily for 8 weeks Receives: Dietary Supplement: Intact cod protein from fillet |
| Intact cod protein from residual material | Experimental | Dietary supplement: intact cod protein from residual material, 8 g protein daily for 8 weeks Receives: Dietary Supplement: Intact cod protein from residual material |
| Control | Experimental | Control group receive tablet containing fillers and no proteins Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers related to lipid metabolism
Lipids will be measured in fasting serum samples
Measured: 8 weeks
Secondary outcomes (3)
Biomarkers related to glucose regulation
Glucose, insulin and GLP-1 and will be measured in serum/plasma sampled in fasting and postprandial conditions.
Measured: 8 weeks
Inflammatory markers
Cytokines will be measured in fasting serum/plasma
Measured: 8 weeks
Body composition
Percent body fat will be measured using bioimpedance
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study startJan 2017
- Primary completionDec 2019
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway, K. Halstensen AS, Regional Research Fund Western Norway, Nofima
- Responsible party
- Principal investigator, Oddrun Anita Gudbrandsen, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03538821
- Sponsor's protocol ID
- 2015/75 part 1
- Acronym
- COD2017
- Status last verified
- Jan 2022
- First submitted
- 14 May 2018
- Last updated
- 4 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22647247Drotningsvik 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.
PubMed 27751188
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03538821
- Acronym / sponsor ID
- COD2017 / 2015/75 part 1
- Conditions
- Overweight and Obesity, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- The Research Council of Norway, K. Halstensen AS, Regional Research Fund Western Norway, Nofima
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 29 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intact cod protein from fillet | Experimental | Dietary Supplement: Intact cod protein from filletDietary supplement: intact cod protein from fillet, 8 g protein daily for 8 weeks |
| Intact cod protein from residual material | Experimental | Dietary Supplement: Intact cod protein from residual materialDietary supplement: intact cod protein from residual material, 8 g protein daily for 8 weeks |
| Control | Experimental | Dietary Supplement: ControlControl group receive tablet containing fillers and no proteins |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI ≥ 27 kg/m2
- Fasting blood glucose ≤7 mmol/L
- Physically inactive
- Percent body fat > 25 % for men and > 35 % for women
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intact cod protein from filletIntact cod protein from fillet 8 g protein daily for 8 weeks | Dietary supplement | Intact cod protein from fillet |
| Intact cod protein from residual materialIntact cod protein from residual material, 8 g protein daily for 8 weeks | Dietary supplement | Intact cod protein from residual material |
| ControlControl group receive tablet containing fillers | Dietary supplement | Control |
Primary outcome
Biomarkers related to lipid metabolism
Time frame: 8 weeks
Lipids will be measured in fasting serum samples
3 secondary outcomes
Biomarkers related to glucose regulation
Time frame: 8 weeks
Inflammatory markers
Time frame: 8 weeks
Body composition
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Background: PubMed 22647247Vikoren 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.
- Background: PubMed 27751188Drotningsvik 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intact cod protein from fillet and Intact cod protein from residual material in people with Overweight and Obesity and Healthy, run by University of Bergen at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers related to lipid metabolism (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03538821, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.