ObesityFISK3NCT01641055
A Study of the Effects of Fish Protein Intake on Glucose Regulation in Overweight and Obese Adults.
A study testing Salmon protein hydrolysate, Herring protein hydrolysate and Cod protein in people with Obesity and Overweight, run by University of Bergen at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Salmon protein hydrolysate, Herring protein hydrolysate and Cod protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 1 siteNorway
- Study dates
- Jul 2012to Nov 2012
- 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 18 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI above 27 kg/m2
- healthy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the detailed description
Participants receive 2.5g protein per day for 8 weeks as tablets.
- Conditions
- Obesity, Overweight
- Being tested
- Salmon protein hydrolysate, Herring protein hydrolysate, Cod protein, Milk protein
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salmon protein hydrolysateDietary supplement
2.5g salmon protein hydrolysate per day for 8wk.
Herring protein hydrolysateDietary supplement
2.5g herring protein hydrolysate per day for 8wk.
Cod proteinDietary supplement
2.5g cod protein per day for 8wk.
Milk proteinDietary supplement
2.5g milk protein per day for 8wk.
| Study group | Role | What they receive |
|---|---|---|
| Salmon protein hydrolysate | Experimental | Not described Receives: Dietary Supplement: Salmon protein hydrolysate |
| Herring protein hydrolysate | Experimental | Not described Receives: Dietary Supplement: Herring protein hydrolysate |
| Cod protein | Sham comparator | Not described Receives: Dietary Supplement: Cod protein |
| Milk protein | Placebo comparator | Not described Receives: Dietary Supplement: Milk protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose regulation
Glucose will be measured in fasting and postprandial samples
Measured: 8 weeks
Secondary outcomes (4)
Changes in serum insulin, insulin C-peptide, non-esterified fatty acids, lipids, adiponectin, leptin and fatty acid composition
Measured: 8 weeks
Changes in serum and urine concentrations of amino acids and their metabolites
Measured: 8 weeks
Changes in serum concentrations of vitamins
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 posted16 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionNov 2012
- Study completionNov 2012
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 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- BlueProtein, NutriMar
- Responsible party
- Principal investigator, Oddrun Anita Gudbrandsen, University of Bergen
- Investigators
- Oddrun A Gudbrandsen, PhD, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01641055
- Sponsor's protocol ID
- 2011/572
- Acronym
- FISK3
- Status last verified
- Mar 2022
- First submitted
- 12 Jul 2012
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30972484
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
- 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.
- ClinicalTrials.gov ID
- NCT01641055
- Acronym / sponsor ID
- FISK3 / 2011/572
- Conditions
- Obesity, Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- BlueProtein, NutriMar
- Study start
- Jul 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 16 Jul 2012 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Salmon protein hydrolysate | Experimental | Dietary Supplement: Salmon protein hydrolysate |
| Herring protein hydrolysate | Experimental | Dietary Supplement: Herring protein hydrolysate |
| Cod protein | Sham comparator | Dietary Supplement: Cod protein |
| Milk protein | Placebo comparator | Dietary Supplement: Milk protein |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI above 27 kg/m2
- healthy
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Salmon protein hydrolysate2.5g salmon protein hydrolysate per day for 8wk. | Dietary supplement | Salmon protein hydrolysate |
| Herring protein hydrolysate2.5g herring protein hydrolysate per day for 8wk. | Dietary supplement | Herring protein hydrolysate |
| Cod protein2.5g cod protein per day for 8wk. | Dietary supplement | Cod protein |
| Milk protein2.5g milk protein per day for 8wk. | Dietary supplement | Milk protein |
Primary outcome
Glucose regulation
Time frame: 8 weeks
Glucose will be measured in fasting and postprandial samples
4 secondary outcomes
Changes in serum insulin, insulin C-peptide, non-esterified fatty acids, lipids, adiponectin, leptin and fatty acid composition
Time frame: 8 weeks
Changes in serum and urine concentrations of amino acids and their metabolites
Time frame: 8 weeks
Changes in serum concentrations of vitamins
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.
- Derived from this study: PubMed 30972484Hovland 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.
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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.
Oddrun A Gudbrandsen, PhD principal investigator
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salmon protein hydrolysate, Herring protein hydrolysate and Cod protein in people with Obesity and Overweight, 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 2 inclusion and 8 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 regulation (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 NCT01641055, 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.