Impaired Glucose ToleranceFishMealNCT03764423
Health Effects of Salmon Fishmeal in Humans
A study testing Salmon fishmeal and Microcrystalline cellulose in people with Impaired Glucose Tolerance, run by University of Oslo at 1 site in Norway.
Trial summary
Diabetes contributes significantly to the burden of disease in Norway and cardiovascular disease is the main cause of mortality. Both lean and fatty fish are shown to have beneficial health effects. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Impaired Glucose Tolerance
- What is being tested?
- Salmon fishmeal and Microcrystalline cellulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteNorway
- Study dates
- 14 Sep 2018to 1 Nov 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fasting plasma glucose ≥ 5.6 mmol/l or
- Plasma glucose ≥ 6.5 mmol/l 2h after an OGTT or
- HbA1c ≥ 5.8 %
Who cannot join
- Diabetes (defined as p-glucose ≥ 7.0 mmol/l p-glucose ≥11,1 mmol/l 2h after OGTT or HbA1c ≥ 6.5 %)
- High fish intake (> 450 gram/week) or fish allergy
- Age-related elevated blood pressure (≥ 70 år: ≥ 180/110 mmHg, > 40-70: ≥ 170/100 mmHg and ≤ 40 år: ≥ 160/100 mmHg)
- Use of prescription medicines related to diabetes, inflammation, systemic use of corticosteroids.
- Non-stable use of lipid lowering drugs, thyroxine, blood pressure lowering drugs, drugs affecting appetite, dietary supplements (including n-3)
- High intake of protein supplements powder
- Pregnancy
- Planning pregnancy or changes in body weight
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Health Effects of Salmon Fishmeal in Humans With Impaired Glucose Tolerance
Diabetes contributes significantly to the burden of disease in Norway and cardiovascular disease is the main cause of mortality.
Both lean and fatty fish are shown to have beneficial health effects. In addition to omega-3 fatty acids, fish contain potential health-promoting components such as taurine, vitamin D, vitamin B12, iodine, selenium and more unspecified components such as bioactive peptides. With the expected growth in the aquaculture sector, more protein-rich by-products will become available.
Read more
The overall aim of this project is to investigate the health beneficial effects of fish protein in the form of salmon fishmeal in a human intervention study with regard to metabolic risk markers.
We will include subjects with impaired glucose tolerance to a randomized controlled parallel study. The subjects will receive capsules with fishmeal or placebo.
- Conditions
- Impaired Glucose Tolerance
- Being tested
- Salmon fishmeal, Microcrystalline cellulose
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salmon fishmealDietary supplement
Also called Fish protein
Salmon fishmeal with high protein content
Microcrystalline celluloseDietary supplement
Also called Cellulose
Microcrystalline cellulose contain no energy and is less fermented in the gut than other dietary fibers.
| Study group | Role | What they receive |
|---|---|---|
| Salmon fishmeal | Experimental | 7,5 g fishmeal and 7,5 g microcrytalline cellulose per day in capsules by mounth for 8 weeks Receives: Dietary Supplement: Salmon fishmeal |
| Microcrystalline cellulose | Placebo comparator | 7,5 g microcrystalline cellulose per day in capsules by mounth for 8 weeks Receives: Dietary Supplement: Microcrystalline cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 hour postprandial blood glucose concentration
Glucose concentration measured before and after a standard glucose tolerance test at baseline and after 8 weeks
Measured: Change in 2 hour blood glucose concentration from baseline and after 8 weeks between groups
Fasting blood glucose concentration
Measured at baseline and after 8 weeks.
Measured: Change in blood glucose concentration from baseline and after 8 weeks between groups
Secondary outcomes (4)
Blood concentration of insulin
Blood concentration measured fasting and 2 hours after an oral glucose tolerance test
Measured: Changes in blood insulin concentration from baseline and after 8 weeks between groups
HOMA-IR
Blood concentration of insulin x blood concentration of glucose will be used to calculate HOMAR-IR fasting and 2 hours after an oral glucose tolerance test
Measured: Changes in HOMAR-IR from baseline and after 8 weeks between groups
Blood concentration of HbA1c
Blood concentration measured fasting
Measured: Changes in blood HbA1c concentration from baseline and after 8 weeks between groups
Blood concentration of incretins (i.e. GLP-1)
Blood concentration of incretins measured fasting and 2 hours after oral glucose tolerance test
Measured: Changes in blood glucose concentration of increstins from baseline and after 8 weeks between groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start14 Sep 2018
- Primary completion1 Nov 2019
- Study completion1 Nov 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 Impaired Glucose ToleranceStudies 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
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirsten Holven, University of Oslo
- Investigators
- Kirsten Holven, Professor, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764423
- Sponsor's protocol ID
- 901420
- Acronym
- FishMeal
- Status last verified
- Sep 2021
- First submitted
- 29 Jun 2018
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hustad KS, Ottestad I, Olsen T, Saether T, Ulven SM, Holven KB. Salmon fish protein supplement increases serum vitamin B12 and selenium concentrations: secondary analysis of a randomised controlled trial. Eur J Nutr. 2022 Sep;61(6):3085-3093. doi: 10.1007/s00394-022-02857-4. Epub 2022 Apr 1.
PubMed 35362766
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Effects of Salmon Fishmeal in Humans With Impaired Glucose Tolerance
- ClinicalTrials.gov ID
- NCT03764423
- Acronym / sponsor ID
- FishMeal / 901420
- Conditions
- Impaired Glucose Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Study start
- 14 Sep 2018 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 5 Dec 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.
Diabetes contributes significantly to the burden of disease in Norway and cardiovascular disease is the main cause of mortality.
Both lean and fatty fish are shown to have beneficial health effects. In addition to omega-3 fatty acids, fish contain potential health-promoting components such as taurine, vitamin D, vitamin B12, iodine, selenium and more unspecified components such as bioactive peptides. With the expected growth in the aquaculture sector, more protein-rich by-products will become available.
The overall aim of this project is to investigate the health beneficial effects of fish protein in the form of salmon fishmeal in a human intervention study with regard to metabolic risk markers.
We will include subjects with impaired glucose tolerance to a randomized controlled parallel study. The subjects will receive capsules with fishmeal or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salmon fishmeal | Experimental | Dietary Supplement: Salmon fishmeal7,5 g fishmeal and 7,5 g microcrytalline cellulose per day in capsules by mounth for 8 weeks |
| Microcrystalline cellulose | Placebo comparator | Dietary Supplement: Microcrystalline cellulose7,5 g microcrystalline cellulose per day in capsules by mounth for 8 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fasting plasma glucose ≥ 5.6 mmol/l or
- Plasma glucose ≥ 6.5 mmol/l 2h after an OGTT or
- HbA1c ≥ 5.8 %
Key exclusion criteria (8 listed)
- Diabetes (defined as p-glucose ≥ 7.0 mmol/l p-glucose ≥11,1 mmol/l 2h after OGTT or HbA1c ≥ 6.5 %)
- High fish intake (> 450 gram/week) or fish allergy
- Age-related elevated blood pressure (≥ 70 år: ≥ 180/110 mmHg, > 40-70: ≥ 170/100 mmHg and ≤ 40 år: ≥ 160/100 mmHg)
- Use of prescription medicines related to diabetes, inflammation, systemic use of corticosteroids.
- Non-stable use of lipid lowering drugs, thyroxine, blood pressure lowering drugs, drugs affecting appetite, dietary supplements (including n-3)
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 fishmealAlso: Fish proteinSalmon fishmeal with high protein content | Dietary supplement | Salmon fishmeal |
| Microcrystalline celluloseAlso: CelluloseMicrocrystalline cellulose contain no energy and is less fermented in the gut than other dietary fibers. | Dietary supplement | Microcrystalline cellulose |
Primary outcome
2 hour postprandial blood glucose concentration
Time frame: Change in 2 hour blood glucose concentration from baseline and after 8 weeks between groups
Glucose concentration measured before and after a standard glucose tolerance test at baseline and after 8 weeks
Fasting blood glucose concentration
Time frame: Change in blood glucose concentration from baseline and after 8 weeks between groups
Measured at baseline and after 8 weeks.
4 secondary outcomes
Blood concentration of insulin
Time frame: Changes in blood insulin concentration from baseline and after 8 weeks between groups
HOMA-IR
Time frame: Changes in HOMAR-IR from baseline and after 8 weeks between groups
Blood concentration of HbA1c
Time frame: Changes in blood HbA1c concentration from baseline and after 8 weeks between groups
Blood concentration of incretins (i.e. GLP-1)
Time frame: Changes in blood glucose concentration of increstins from baseline and after 8 weeks between groups
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 28 Sep 2021.
- Derived from this study: PubMed 35362766Hustad KS, Ottestad I, Olsen T, Saether T, Ulven SM, Holven KB. Salmon fish protein supplement increases serum vitamin B12 and selenium concentrations: secondary analysis of a randomised controlled trial. Eur J Nutr. 2022 Sep;61(6):3085-3093. doi: 10.1007/s00394-022-02857-4. Epub 2022 Apr 1.
- 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.
Kirsten Holven, Professor principal investigator
University of Oslo
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 fishmeal and Microcrystalline cellulose in people with Impaired Glucose Tolerance, run by University of Oslo 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 3 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 28 Sep 2021. 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?
2 hour postprandial blood glucose concentration (time frame: Change in 2 hour blood glucose concentration from baseline and after 8 weeks between groups). The study lists 2 primary outcomes in all. 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 NCT03764423, 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 28 Sep 2021.