Health Effects of Salmon Fishmeal in Humans

Study Overview
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Brief Summary
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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.

Official Title
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Health Effects of Salmon Fishmeal in Humans With Impaired Glucose Tolerance

Conditions
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Impaired Glucose Tolerance

Intervention / Treatment
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* Dietary Supplement: Salmon fishmeal
* Dietary Supplement: Microcrystalline cellulose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Salmon fishmeal<br>7,5 g fishmeal and 7,5 g microcrytalline cellulose per day in capsules by mounth for 8 weeks | Dietary Supplement: Salmon fishmeal<br>* Salmon fishmeal with high protein content<br>* Other names: Fish protein;|
| Placebo Comparator: Microcrystalline cellulose<br>7,5 g microcrystalline cellulose per day in capsules by mounth for 8 weeks | Dietary Supplement: Microcrystalline cellulose<br>* Microcrystalline cellulose contain no energy and is less fermented in the gut than other dietary fibers.<br>* Other names: Cellulose;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2 hour postprandial blood glucose concentration | Glucose concentration measured before and after a standard glucose tolerance test at baseline and after 8 weeks | Change in 2 hour blood glucose concentration from baseline and after 8 weeks between groups | 
| Fasting blood glucose concentration | Measured at baseline and after 8 weeks. | Change in blood glucose concentration from baseline and after 8 weeks between groups | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood concentration of insulin | Blood concentration measured fasting and 2 hours after an oral glucose tolerance test | Changes in blood insulin concentration from baseline and after 8 weeks between groups | 
| HOMA-IR | 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 | Changes in HOMAR-IR from baseline and after 8 weeks between groups | 
| Blood concentration of HbA1c | Blood concentration measured fasting | Changes in blood HbA1c concentration from baseline and after 8 weeks between groups | 
| Blood concentration of incretins (i.e. GLP-1) | Blood concentration of incretins measured fasting and 2 hours after oral glucose tolerance test | Changes in blood glucose concentration of increstins from baseline and after 8 weeks between groups |