Health Effects of Salmon Fishmeal in Humans
- Conditions
- Impaired Glucose Tolerance
- Interventions
- Dietary Supplement: Salmon fishmealDietary Supplement: Microcrystalline cellulose
- Registration Number
- NCT03764423
- Lead Sponsor
- University of Oslo
- Brief 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. 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 the health beneficial effects of fish protein in the form of salmon fishmeal in a human intervention study with regard to metabolic risk markers.
We will include subjects with impaired glucose tolerance to a randomized controlled parallel study. The subjects will receive capsules with fishmeal or placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 88
- Fasting plasma glucose ≥ 5.6 mmol/l or
- Plasma glucose ≥ 6.5 mmol/l 2h after an OGTT or
- HbA1c ≥ 5.8 %
Exclusion criteria:
- Diabetes (defined as p-glucose ≥ 7.0 mmol/l p-glucose ≥11,1 mmol/l 2h after OGTT or HbA1c ≥ 6.5 %)
- High fish intake (> 450 gram/week) or fish allergy
- Age-related elevated blood pressure (≥ 70 år: ≥ 180/110 mmHg, > 40-70: ≥ 170/100 mmHg and ≤ 40 år: ≥ 160/100 mmHg)
- Use of prescription medicines related to diabetes, inflammation, systemic use of corticosteroids.
- Non-stable use of lipid lowering drugs, thyroxine, blood pressure lowering drugs, drugs affecting appetite, dietary supplements (including n-3)
- High intake of protein supplements powder
- Pregnancy
- Planning pregnancy or changes in body weight
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Salmon fishmeal Salmon fishmeal 7,5 g fishmeal and 7,5 g microcrytalline cellulose per day in capsules by mounth for 8 weeks Microcrystalline cellulose Microcrystalline cellulose 7,5 g microcrystalline cellulose per day in capsules by mounth for 8 weeks
- Primary Outcome Measures
Name Time Method 2 hour postprandial blood glucose concentration Change in 2 hour blood glucose concentration from baseline and after 8 weeks between groups Glucose concentration measured before and after a standard glucose tolerance test at baseline and after 8 weeks
Fasting blood glucose concentration Change in blood glucose concentration from baseline and after 8 weeks between groups Measured at baseline and after 8 weeks.
- Secondary Outcome Measures
Name Time Method Blood concentration of HbA1c Changes in blood HbA1c concentration from baseline and after 8 weeks between groups Blood concentration measured fasting
Blood concentration of incretins (i.e. GLP-1) Changes in blood glucose concentration of increstins from baseline and after 8 weeks between groups Blood concentration of incretins measured fasting and 2 hours after oral glucose tolerance test
Blood concentration of insulin Changes in blood insulin concentration from baseline and after 8 weeks between groups Blood concentration measured fasting and 2 hours after an oral glucose tolerance test
HOMA-IR Changes in HOMAR-IR from baseline and after 8 weeks between groups Blood concentration of insulin x blood concentration of glucose will be used to calculate HOMAR-IR fasting and 2 hours after an oral glucose tolerance test
Trial Locations
- Locations (1)
University of Oslo
🇳🇴Oslo, Post Box 1046, Blindern, Norway