Metabolic DiseaseNCT04078958
Effects of Salmon Fishmeal Ex Vivo (FishMeal Ex Vivo)
A study testing Salmon fishmeal and Whey in people with Metabolic Disease and Inflammation, 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
- Metabolic Disease, Inflammation, Endocrine; Obesity
- What is being tested?
- Salmon fishmeal and Whey
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteNorway
- Study dates
- 15 Oct 2019to 7 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
- Body mass index 18.5-24.9 kg/m2
Who cannot join
- Body mass index <18.5 or >24.9 kg/m2
- Known diabetes or high blood pressure
- Pregnancy or breast feeding
- Allergy or intolerance to dairy or fish/fish protein.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Health Effects of Salmon Fish Meal - ex Vivo Study
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 physiological and molecular effects of fish protein in the form of salmon fishmeal compared to whey in a human intervention study with regard to carbohydrate- and fat metabolism, endocrine factors and inflammation.
The investigators will include healthy subjects to a randomized controlled cross over study. The subjects will receive a single, oral dose of fishmeal or whey. Blood samples are taken before (fasting) and 30 and 60 minutes after intake. The molecular effects of fishmeal and whey are investigated ex vivo. This is done by incubating human cell lines (i.e hepatocytes, adipocytes, epithelial cells) with fasting and postprandial serum from the participants.
- Conditions
- Metabolic Disease, Inflammation, Endocrine; Obesity
- Being tested
- Salmon fishmeal, Whey
- Medical subject headings
- Metabolic Diseases, Inflammation, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salmon fishmealDietary supplement
Salmon fishmeal with high protein content
WheyDietary supplement
Whey with high protein content
| Study group | Role | What they receive |
|---|---|---|
| Salmon fishmeal | Experimental | 5 g fishmeal in capsules, single oral dose Receives: Dietary Supplement: Salmon fishmeal |
| Whey | Active comparator | 5 g whey in capsules, single oral dose Receives: Dietary Supplement: Whey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the whole genome transciptome in cultured cells
Changes in the whole genome transciptome of cultured cells incubated with fasting and postprandial serum from participants receiving whey or fishmeal.
Measured: Acute changes from baseline to 30 and/or 60 minutes.
Secondary outcomes (10)
Changes in histone marks on selected target genes in cultured cell lines
Changes in histone marks on selected target genes in cultured cells incubated with fasting or postprandial serum from participants receiving whey or fishmeal.
Measured: Acute changes from baseline to 30 and/or 60 minutes.
Changes in insulin-stimulated glucose uptake in cultured cell lines
Changes in insulin sensitivity measured as insulin-stimulated glucose uptake of cultured cells incubated with fasting and postprandial serum from participants receiving whey or fishmeal.
Measured: Acute changes from baseline to 30 and/or 60 minutes.
Changes in cytokine secretion in cultured cell lines
Changes in inflammatory and endocrine factors measured as the secretion of single cytokines from cultured cells incubated with fasting and postprandial serum from participants receiving whey or fishmeal. The choice of factors will be guided by the results from the primary endpoint.
Measured: Acute changes from baseline to 30 and/or 60 minutes.
Blood concentration of insulin
Blood concentration of insulin in participants receiving whey or fishmeal.
Measured: Acute changes from baseline to 30 and 60 minutes
Blood concentration of glucose
Blood concentration of glucose in participants receiving whey or fishmeal.
Measured: Acute changes from baseline to 30 and 60 minutes
Blood concentration of triglycerides
Blood concentration of triglycerides in participants receiving whey or fishmeal.
Measured: Acute changes from baseline to 30 and 60 minutes
Blood concentration of cholesterol
Blood concentration of total cholesterol in participants receiving whey or fishmeal.
Measured: Acute changes from baseline to 30 and 60 minutes
Markers in blood related to appetite
Blood concentration of the appetite hormones, i.e. GLP-1, Leptin and GIP in participants receiving whey or fishmeal.
Measured: Acute changes from baseline to 30 and 60 minutes
Markers in blood related to low grade inflammation
Blood concentration of microCRP in participants receiving whey or fishmeal.
Measured: Acute changes from baseline to 30 and 60 minutes
Markers in blood related to digestion of protein
Blood concentration of amino acids and small peptides in participants receiving whey or fishmeal.
Measured: Acute changes from baseline to 30 and/or 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start15 Oct 2019
- Primary completion7 Nov 2019
- Study completion7 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DiseaseStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5 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, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078958
- Sponsor's protocol ID
- 2019/875/REK sør-øst B
- Status last verified
- Sep 2021
- First submitted
- 29 Aug 2019
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 Fish Meal - ex Vivo Study
- ClinicalTrials.gov ID
- NCT04078958
- Acronym / sponsor ID
- 2019/875/REK sør-øst B
- Conditions
- Metabolic Disease, Inflammation, Endocrine; Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 7 Nov 2019 (actual)
- Study completion
- 7 Nov 2019 (actual)
- First posted
- 6 Sep 2019 (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 physiological and molecular effects of fish protein in the form of salmon fishmeal compared to whey in a human intervention study with regard to carbohydrate- and fat metabolism, endocrine factors and inflammation.
The investigators will include healthy subjects to a randomized controlled cross over study. The subjects will receive a single, oral dose of fishmeal or whey. Blood samples are taken before (fasting) and 30 and 60 minutes after intake. The molecular effects of fishmeal and whey are investigated ex vivo. This is done by incubating human cell lines (i.e hepatocytes, adipocytes, epithelial cells) with fasting and postprandial serum from the participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salmon fishmeal | Experimental | Dietary Supplement: Salmon fishmeal5 g fishmeal in capsules, single oral dose |
| Whey | Active comparator | Dietary Supplement: Whey5 g whey in capsules, single oral dose |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Body mass index 18.5-24.9 kg/m2
Key exclusion criteria (4 listed)
- Body mass index <18.5 or >24.9 kg/m2
- Known diabetes or high blood pressure
- Pregnancy or breast feeding
- Allergy or intolerance to dairy or fish/fish protein.
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 fishmealSalmon fishmeal with high protein content | Dietary supplement | Salmon fishmeal |
| WheyWhey with high protein content | Dietary supplement | Whey |
Primary outcome
Changes in the whole genome transciptome in cultured cells
Time frame: Acute changes from baseline to 30 and/or 60 minutes.
Changes in the whole genome transciptome of cultured cells incubated with fasting and postprandial serum from participants receiving whey or fishmeal.
10 secondary outcomes
Changes in histone marks on selected target genes in cultured cell lines
Time frame: Acute changes from baseline to 30 and/or 60 minutes.
Changes in insulin-stimulated glucose uptake in cultured cell lines
Time frame: Acute changes from baseline to 30 and/or 60 minutes.
Changes in cytokine secretion in cultured cell lines
Time frame: Acute changes from baseline to 30 and/or 60 minutes.
Blood concentration of insulin
Time frame: Acute changes from baseline to 30 and 60 minutes
Blood concentration of glucose
Time frame: Acute changes from baseline to 30 and 60 minutes
Blood concentration of triglycerides
Time frame: Acute changes from baseline to 30 and 60 minutes
Blood concentration of cholesterol
Time frame: Acute changes from baseline to 30 and 60 minutes
Markers in blood related to appetite
Time frame: Acute changes from baseline to 30 and 60 minutes
Markers in blood related to low grade inflammation
Time frame: Acute changes from baseline to 30 and 60 minutes
Markers in blood related to digestion of protein
Time frame: Acute changes from baseline to 30 and/or 60 minutes
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.
- 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 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 Whey in people with Metabolic Disease and Inflammation, 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 1 inclusion and 4 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. 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?
Changes in the whole genome transciptome in cultured cells (time frame: Acute changes from baseline to 30 and/or 60 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.