Metabolic DisordersFISK1NCT02130908
A Study on the Possible Health Effects of Lean Fish, Fatty Fish and Lean Meat Intake in Non-obese Adults
A study testing Lean fish, Fatty fish and Lean meat in people with Metabolic Disorders and Obesity, run by University of Bergen at 1 site in Norway.
Trial summary
This study is a pilot study to investigate whether intake of lean or fatty fish, or lean meat would affect parameters related to health in healthy non-obese adults, and will serve as basis for future calculation of group sizes in coming studies. Participants consumed 750g/week of fillets of fish or meat for 4 weeks. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disorders, Obesity
- What is being tested?
- Lean fish, Fatty fish and Lean meat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2011to Jul 2015
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- adults
- non-obese
- healthy
Who cannot join
- diabetes
- diagnosed diseases of the intestine or cardiovacular system
Trial locations and contacts
1 site in 1 country.
About this study
This study is a pilot study to investigate whether intake of lean or fatty fish, or lean meat would affect parameters related to health in healthy non-obese adults, and will serve as basis for future calculation of group sizes in coming studies. Participants consumed 750g/week of fillets of fish or meat for 4 weeks.
Hypothesis:
High intake of either lean or fatty fish will not affect serum concentrations of lipids and inflammatory markers as well as improve glucose tolerance during the 4 week intervention period when compared to lean meat intake.
- Conditions
- Metabolic Disorders, Obesity
- Being tested
- Lean fish, Fatty fish, Lean meat
- Medical subject headings
- Metabolic Diseases, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lean fishOther
Participants consumed 150g of lean fish, five times per week for 4 weeks
Fatty fishOther
Participants consumed 150g of fatty fish, five times per week for 4 weeks
Lean meatOther
Participants consumed 150g of lean meat, five times per week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Lean fish | Experimental | Not described Receives: Other: Lean fish |
| Fatty fish | Experimental | Not described Receives: Other: Fatty fish |
| Lean meat | Experimental | Not described Receives: Other: Lean meat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in metabolic parameters (lipids, glucose, inflammatory markers) measured in serum
Measured: Endpoint after 4 weeks intervention
Secondary outcomes (1)
Changes in body weight
Measured: Endpoint after 4 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startMar 2011
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DisordersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- Bergen Medical Research Foundation, Skretting ASA, Leroy Seafood Group ASA
- Responsible party
- Principal investigator, Oddrun Anita Gudbrandsen, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130908
- Sponsor's protocol ID
- REK2011/572
- Acronym
- FISK1
- Status last verified
- May 2018
- First submitted
- 1 May 2014
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Possible Health Effects of Lean Fish, Fatty Fish and Lean Meat Intake in Non-obese Adults
- ClinicalTrials.gov ID
- NCT02130908
- Acronym / sponsor ID
- FISK1 / REK2011/572
- Conditions
- Metabolic Disorders, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- Bergen Medical Research Foundation, Skretting ASA, Leroy Seafood Group ASA
- Study start
- Mar 2011
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 6 May 2014 (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.
This study is a pilot study to investigate whether intake of lean or fatty fish, or lean meat would affect parameters related to health in healthy non-obese adults, and will serve as basis for future calculation of group sizes in coming studies. Participants consumed 750g/week of fillets of fish or meat for 4 weeks.
Hypothesis:
High intake of either lean or fatty fish will not affect serum concentrations of lipids and inflammatory markers as well as improve glucose tolerance during the 4 week intervention period when compared to lean meat intake.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lean fish | Experimental | Other: Lean fish |
| Fatty fish | Experimental | Other: Fatty fish |
| Lean meat | Experimental | Other: Lean meat |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- adults
- non-obese
- healthy
Key exclusion criteria (2 listed)
- diabetes
- diagnosed diseases of the intestine or cardiovacular system
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 |
|---|---|---|
| Lean fishParticipants consumed 150g of lean fish, five times per week for 4 weeks | Other | Lean fish |
| Fatty fishParticipants consumed 150g of fatty fish, five times per week for 4 weeks | Other | Fatty fish |
| Lean meatParticipants consumed 150g of lean meat, five times per week for 4 weeks | Other | Lean meat |
Primary outcome
Changes in metabolic parameters (lipids, glucose, inflammatory markers) measured in serum
Time frame: Endpoint after 4 weeks intervention
1 secondary outcome
Changes in body weight
Time frame: Endpoint after 4 weeks intervention
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 2 May 2018.
Related trials for Metabolic Disorders
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
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 Lean fish, Fatty fish and Lean meat in people with Metabolic Disorders 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 3 inclusion and 2 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 2 May 2018. 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 metabolic parameters (lipids, glucose, inflammatory markers) measured in serum (time frame: Endpoint after 4 weeks intervention). 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 2 May 2018.