Effects of Salmon Fishmeal Ex Vivo (FishMeal Ex Vivo)

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 physiological and molecular effects of fish protein in the form of salmon fishmeal compared to whey in a human intervention study with regard to carbohydrate- and fat metabolism, endocrine factors and inflammation. The investigators will include healthy subjects to a randomized controlled cross over study. The subjects will receive a single, oral dose of fishmeal or whey. Blood samples are taken before (fasting) and 30 and 60 minutes after intake. The molecular effects of fishmeal and whey are investigated ex vivo. This is done by incubating human cell lines (i.e hepatocytes, adipocytes, epithelial cells) with fasting and postprandial serum from the participants.

Official Title
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Health Effects of Salmon Fish Meal - ex Vivo Study

Conditions
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Metabolic Disease, Inflammation, Endocrine; Obesity

Intervention / Treatment
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* Dietary Supplement: Salmon fishmeal
* Dietary Supplement: Whey


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index 18.5-24.9 kg/m2 Exclusion Criteria: Body mass index <18.5 or >24.9 kg/m2 Known diabetes or high blood pressure Pregnancy or breast feeding Allergy or intolerance to dairy or fish/fish protein.

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Salmon fishmeal<br>5 g fishmeal in capsules, single oral dose | Dietary Supplement: Salmon fishmeal<br>* Salmon fishmeal with high protein content<br>|
| Active Comparator: Whey<br>5 g whey in capsules, single oral dose | Dietary Supplement: Whey<br>* Whey with high protein content<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the whole genome transciptome in cultured cells | Changes in the whole genome transciptome of cultured cells incubated with fasting and postprandial serum from participants receiving whey or fishmeal. | Acute changes from baseline to 30 and/or 60 minutes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in histone marks on selected target genes in cultured cell lines | Changes in histone marks on selected target genes in cultured cells incubated with fasting or postprandial serum from participants receiving whey or fishmeal. | Acute changes from baseline to 30 and/or 60 minutes. | 
| Changes in insulin-stimulated glucose uptake in cultured cell lines | Changes in insulin sensitivity measured as insulin-stimulated glucose uptake of cultured cells incubated with fasting and postprandial serum from participants receiving whey or fishmeal. | Acute changes from baseline to 30 and/or 60 minutes. | 
| Changes in cytokine secretion in cultured cell lines | Changes in inflammatory and endocrine factors measured as the secretion of single cytokines from cultured cells incubated with fasting and postprandial serum from participants receiving whey or fishmeal. The choice of factors will be guided by the results from the primary endpoint. | Acute changes from baseline to 30 and/or 60 minutes. | 
| Blood concentration of insulin | Blood concentration of insulin in participants receiving whey or fishmeal. | Acute changes from baseline to 30 and 60 minutes | 
| Blood concentration of glucose | Blood concentration of glucose in participants receiving whey or fishmeal. | Acute changes from baseline to 30 and 60 minutes | 
| Blood concentration of triglycerides | Blood concentration of triglycerides in participants receiving whey or fishmeal. | Acute changes from baseline to 30 and 60 minutes | 
| Blood concentration of cholesterol | Blood concentration of total cholesterol in participants receiving whey or fishmeal. | Acute changes from baseline to 30 and 60 minutes | 
| Markers in blood related to appetite | Blood concentration of the appetite hormones, i.e. GLP-1, Leptin and GIP in participants receiving whey or fishmeal. | Acute changes from baseline to 30 and 60 minutes | 
| Markers in blood related to low grade inflammation | Blood concentration of microCRP in participants receiving whey or fishmeal. | Acute changes from baseline to 30 and 60 minutes | 
| Markers in blood related to digestion of protein | Blood concentration of amino acids and small peptides in participants receiving whey or fishmeal. | Acute changes from baseline to 30 and/or 60 minutes |