HealthyNCT02025933
Project Healthy Eating in Children. A Study on the Health Effects of Fish Intake in Overweight Children
An observational study of Healthy, run by University of Bergen at 1 site in Norway.
Trial summary
It has previously been seen 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 improve metabolic health in children aged 9-12… Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Salmon Group, Cod Group and Meat Group
- How many people
- 25 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2014to Aug 2015
- Phase
- Observational
- 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 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Cildren aged 9-12 years are invited to participate in the study. The children must be healthy and not use prescription medications that affects lipid metabolism, glucose regulation or the immunesystem.
Who may be able to join
- overweight (iso-BMI > 25)
- 9-12 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: Ung og Frisk. En Studie av Helseeffekter av Fiskeinntak i Overvektige Barn.
It has previously been seen 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 improve metabolic health in children aged 9-12 years as well when replacing processed food. The hypothesis is that increased intake of unprocessed fish or meat will improve metabolic health in children as measured by glucose tolerance, lipid metabolism and inflammatory markers.
- Conditions
- Healthy
- Being tested
- Salmon Group, Cod Group, Meat Group
- Keywords
- Children, Age 9-12 years, Overweight (iso-BMI > 25)
- 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
The children are advised to eat at least 75g of salmon per serving, but no more than 150g
Cod GroupOther
The children are advised to eat at least 75g of cod per serving, but no more than 150g
Meat GroupOther
The children are advised to eat at least 75g of meat per serving, but no more than 150g
| Study group | Role | What they receive |
|---|---|---|
| Salmon Group | Participants will eat 75 - 150 grams of salmon for dinner, three times a week for 12 weeks. Receives: Other: Salmon Group | |
| Cod Group | Participants will eat 75-150 grams of cod for dinner, three times a week for 12 weeks. Receives: Other: Cod Group | |
| Meat Group | Participants will eat 75-150 grams of mixed meat for dinner, three times a 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)
We will investigate any changes in the metabolic status by analyzing parameters affected by changes in glucose homeostasis, lipid metabolism and inflammation.
Measured: Baseline and end of intervention period (12 weeks)
Secondary outcomes (1)
Body composition
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 startAug 2014
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: We were unable to recruit a sufficient number of participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 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
- NCT02025933
- Sponsor's protocol ID
- 2013/541
- Status last verified
- May 2016
- First submitted
- 17 Dec 2013
- Last updated
- 24 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Title in Norwegian: Ung og Frisk. En Studie av Helseeffekter av Fiskeinntak i Overvektige Barn.
- ClinicalTrials.gov ID
- NCT02025933
- Acronym / sponsor ID
- 2013/541
- Conditions
- Healthy
- Keywords
- Children, Age 9-12 years, Overweight (iso-BMI > 25)
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: We were unable to recruit a sufficient number of participants
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- The Fisheries and Aquaculture Industry Research Fund
- Study start
- Aug 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (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 seen 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 improve metabolic health in children aged 9-12 years as well when replacing processed food. The hypothesis is that increased intake of unprocessed fish or meat will improve metabolic health in children as measured by glucose tolerance, lipid metabolism and inflammatory markers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Salmon Group | – | Other: Salmon GroupParticipants will eat 75 - 150 grams of salmon for dinner, three times a week for 12 weeks. |
| Cod Group | – | Other: Cod GroupParticipants will eat 75-150 grams of cod for dinner, three times a week for 12 weeks. |
| Meat Group | – | Other: Meat GroupParticipants will eat 75-150 grams of mixed meat for dinner, three times a week for 12 weeks. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Cildren aged 9-12 years are invited to participate in the study. The children must be healthy and not use prescription medications that affects lipid metabolism, glucose regulation or the immunesystem.
Key inclusion criteria (3 listed)
- overweight (iso-BMI > 25)
- 9-12 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 GroupThe children are advised to eat at least 75g of salmon per serving, but no more than 150g | Other | Salmon Group |
| Cod GroupThe children are advised to eat at least 75g of cod per serving, but no more than 150g | Other | Cod Group |
| Meat GroupThe children are advised to eat at least 75g of meat per serving, but no more than 150g | Other | Meat Group |
Primary outcome
Changes in metabolic status (glucose, lipids, inflammation)
Time frame: Baseline and end of intervention period (12 weeks)
We will investigate any changes in the metabolic status by analyzing parameters affected by changes in glucose homeostasis, lipid metabolism and inflammation.
1 secondary outcome
Body composition
Time frame: Baseline and end of intervention (12 weeks)
Results and safety
The study was stopped early (reason given: We were unable to recruit a sufficient number of participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2016.
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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?
An observational study of 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: stopped early, as of the sponsor's last update on 24 May 2016. 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 was stopped early (reason given: We were unable to recruit a sufficient number of participants). Results are not available in the source record.
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 period (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 24 May 2016.