Overweight or Obese AdultsNCT02025920
Project Healthy Eating in Adults. A Study on the Health Effects of Fish Intake in Overweight Adults (FINS)
A study testing Salmon Group, Cod Group and Meat Group in people with Overweight or Obese Adults and Healthy, run by University of Bergen at 1 site in Norway.
Trial summary
It has previously been observed that increased fish intake improves the metabolic health of overweight and obese adults, and animal protein improved metabolic health of obese rats. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight or Obese Adults, Healthy
- What is being tested?
- Salmon Group, Cod Group and Meat Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2014to 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI > 27
- 20-55 years
- healthy
Who cannot join
- diagnosed diseases such as diabetes, CVD, intestinal diseases, arthritis
- prescription medications affecting the metabolism of glucose, lipids or the immune system
- use of supplements containing long chain n-3 fatty acids
- high intake of fish
- food allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Title in Norwegian: Sunn og Frisk. En Studie av Helseeffekter av Fiskeinntak i Overvektige Voksne (FINS)
It has previously been observed that increased fish intake improves the metabolic health of overweight and obese adults, and animal protein improved metabolic health of obese rats. In this project the investigators will investigate whether increased intake of fish or meat improves metabolic health in overweight/obese adults aged 20-55 years when replacing processed food. The hypothesis is that increased intake of unprocessed fish or meat will improve metabolic health in adults as measured by glucose tolerance, lipid metabolism and inflammatory markers.
- Conditions
- Overweight or Obese Adults, Healthy
- Being tested
- Salmon Group, Cod Group, Meat Group
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salmon GroupOther
Cod GroupOther
Meat GroupOther
| Study group | Role | What they receive |
|---|---|---|
| Salmon Group | Experimental | Participants will eat 150g salmon for dinner, 3 times per week for 12 weeks Receives: Other: Salmon Group |
| Cod Group | Experimental | Participants will eat 150g cod for dinner, 3 times per week for 12 weeks Receives: Other: Cod Group |
| Meat Group | Active comparator | Participants will eat 150g mixed meat for dinner, 3 times per week for 12 weeks Receives: Other: Meat Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in metabolic status (glucose, lipids, inflammation)
The effects of fish intake on glucose homeostasis, lipid metabolism and inflammation will be assessed.
Measured: Baseline and end of intervention (12 weeks)
Secondary outcomes (2)
Changes in plasma concentrations of amino acids and their metabolites
Measured: Baseline and end of intervention (12 weeks)
Changes in plasma concentrations of vitamins
Measured: Baseline and end of intervention (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2015
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight or Obese AdultsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- The Fisheries and Aquaculture Industry Research Fund
- 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
- NCT02025920
- Sponsor's protocol ID
- 2013/558
- Status last verified
- Apr 2021
- First submitted
- 17 Dec 2013
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Title in Norwegian: Sunn og Frisk. En Studie av Helseeffekter av Fiskeinntak i Overvektige Voksne (FINS)
- ClinicalTrials.gov ID
- NCT02025920
- Acronym / sponsor ID
- 2013/558
- Conditions
- Overweight or Obese Adults, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- The Fisheries and Aquaculture Industry Research Fund
- Study start
- Jan 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 1 Jan 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.
It has previously been observed that increased fish intake improves the metabolic health of overweight and obese adults, and animal protein improved metabolic health of obese rats. In this project the investigators will investigate whether increased intake of fish or meat improves metabolic health in overweight/obese adults aged 20-55 years when replacing processed food. The hypothesis is that increased intake of unprocessed fish or meat will improve metabolic health in adults as measured by glucose tolerance, lipid metabolism and inflammatory markers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Salmon Group | Experimental | Other: Salmon GroupParticipants will eat 150g salmon for dinner, 3 times per week for 12 weeks |
| Cod Group | Experimental | Other: Cod GroupParticipants will eat 150g cod for dinner, 3 times per week for 12 weeks |
| Meat Group | Active comparator | Other: Meat GroupParticipants will eat 150g mixed meat for dinner, 3 times per week for 12 weeks |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI > 27
- 20-55 years
- healthy
Key exclusion criteria (5 listed)
- diagnosed diseases such as diabetes, CVD, intestinal diseases, arthritis
- prescription medications affecting the metabolism of glucose, lipids or the immune system
- use of supplements containing long chain n-3 fatty acids
- high intake of fish
- food allergy
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 Group | Other | Salmon Group |
| Cod Group | Other | Cod Group |
| Meat Group | Other | Meat Group |
Primary outcome
Changes in metabolic status (glucose, lipids, inflammation)
Time frame: Baseline and end of intervention (12 weeks)
The effects of fish intake on glucose homeostasis, lipid metabolism and inflammation will be assessed.
2 secondary outcomes
Changes in plasma concentrations of amino acids and their metabolites
Time frame: Baseline and end of intervention (12 weeks)
Changes in plasma concentrations of vitamins
Time frame: Baseline and end of intervention (12 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 30 Apr 2021.
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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 Group, Cod Group and Meat Group in people with Overweight or Obese Adults and Healthy, 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 5 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 30 Apr 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 metabolic status (glucose, lipids, inflammation) (time frame: Baseline and end of intervention (12 weeks)). 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 30 Apr 2021.