Healthy Clinical Trial
Official title:
Title in Norwegian: Sunn og Frisk. En Studie av Helseeffekter av Fiskeinntak i Overvektige Voksne (FINS)
| NCT number | NCT02025920 |
| Other study ID # | 2013/558 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | January 2014 |
| Est. completion date | December 2019 |
| Verified date | April 2021 |
| Source | University of Bergen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 183 |
| Est. completion date | December 2019 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 20 Years to 55 Years |
| Eligibility | Inclusion Criteria: - BMI > 27 - 20-55 years - healthy Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Norway | University of Bergen | Bergen |
| Lead Sponsor | Collaborator |
|---|---|
| University of Bergen | The Fisheries and Aquaculture Industry Research Fund |
Norway,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Changes in metabolic status (glucose, lipids, inflammation) | The effects of fish intake on glucose homeostasis, lipid metabolism and inflammation will be assessed. | Baseline and end of intervention (12 weeks) | |
| Secondary | Changes in plasma concentrations of amino acids and their metabolites | Baseline and end of intervention (12 weeks) | ||
| Secondary | Changes in plasma concentrations of vitamins | Baseline and end of intervention (12 weeks) |
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