OverweightFISK4NCT01894542
A Study of the Effects of Intake of Two Cod Residual Meals on Glucose Regulation in Overweight and Obese Adults
A study testing Cod protein from presscake and Cod protein from presscake + stickwater in people with Overweight and Obesity, run by University of Bergen at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Cod protein from presscake and Cod protein from presscake + stickwater
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2013to Dec 2019
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI>28
- healthy
- fasting blood glucose <7.0 mmol/L
- stable body weight with less than 5 kg fluctuation during the last 4 months
Who cannot join
- 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
Show all 9Show fewer
- high seafood consumption
- use of dietary supplements including cod liver oil or other marine fatty acids
- allergies towards fish, milk, egg
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
Participants receive 6g per day of water soluble on non-water soluble cod protein as tablets for 8 weeks.
- Conditions
- Overweight, Obesity
- Being tested
- Cod protein from presscake, Cod protein from presscake + stickwater, 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.
Cod protein from presscakeDietary supplement
6g protein per day for 8wk
Cod protein from presscake + stickwaterDietary supplement
6 g protein per day for 8 wk
ControlDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Cod protein from presscake | Experimental | Not described Receives: Dietary Supplement: Cod protein from presscake |
| Cod protein from presscake + stickwater | Experimental | Not described Receives: Dietary Supplement: Cod protein from presscake + stickwater |
| Control | Placebo comparator | Control group will receive tablet containing only tablet fillers (the same as in the cod protein tablets). Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose tolerance
Serum glucose will be measured in fasting and postprandial state
Measured: 8 weeks
Secondary outcomes (3)
Gene expression
Changes in gene expression in adipose tissue related to the circulating markers of glucose regulation.
Measured: 8 weeks
Amino acids and amino acid metabolites
Amino acids and amino acid metabolites will be measured in serum and urine
Measured: 8 weeks
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
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 posted10 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2014
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- Granit AS Transport & Tourism, Norwegian Seafood Center, Nofima
- Responsible party
- Principal investigator, Oddrun Anita Gudbrandsen, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01894542
- Sponsor's protocol ID
- 2011/572-14
- Acronym
- FISK4
- Status last verified
- Mar 2022
- First submitted
- 3 Jul 2013
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- 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 22647247
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01894542
- Acronym / sponsor ID
- FISK4 / 2011/572-14
- Conditions
- Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- Granit AS Transport & Tourism, Norwegian Seafood Center, Nofima
- Study start
- Aug 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 10 Jul 2013 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cod protein from presscake | Experimental | Dietary Supplement: Cod protein from presscake |
| Cod protein from presscake + stickwater | Experimental | Dietary Supplement: Cod protein from presscake + stickwater |
| Control | Placebo comparator | Dietary Supplement: ControlControl group will receive tablet containing only tablet fillers (the same as in the cod protein tablets). |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI>28
- healthy
- fasting blood glucose <7.0 mmol/L
- stable body weight with less than 5 kg fluctuation during the last 4 months
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Cod protein from presscake6g protein per day for 8wk | Dietary supplement | Cod protein from presscake |
| Cod protein from presscake + stickwater6 g protein per day for 8 wk | Dietary supplement | Cod protein from presscake + stickwater |
| Control | Dietary supplement | Control |
Primary outcome
Glucose tolerance
Time frame: 8 weeks
Serum glucose will be measured in fasting and postprandial state
3 secondary outcomes
Gene expression
Time frame: 8 weeks
Amino acids and amino acid metabolites
Time frame: 8 weeks
Comparisons of metabolites and co-factors involved in one-carbon metabolism in serum and urine
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 7 Apr 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.
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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 Cod protein from presscake and Cod protein from presscake + stickwater in people with Overweight and Obesity, 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 9 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 7 Apr 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. Some participants in this study may receive a placebo. 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?
Glucose tolerance (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 NCT01894542, which also lists 1 linked publication.
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 7 Apr 2022.