Effects of Salmon Fishmeal Ex Vivo (FishMeal Ex Vivo)

Not Applicable

Completed

• Conditions: Inflammation; Endocrine; Obesity; Metabolic Disease
• Interventions: Dietary Supplement: Salmon fishmeal; Dietary Supplement: Whey

• Registration Number: NCT04078958
• 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-29
• Study First Submitted QC: 2019-09-02
• Study First Posted: 2019-09-06
• Study Start: 2019-10-15
• Primary Completion: 2019-11-07
• Study Completion: 2019-11-07
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Salmon fishmeal	Salmon fishmeal	5 g fishmeal in capsules, single oral dose
Whey	Whey	5 g whey in capsules, single oral dose

Primary Outcome Measures

Name	Time	Method
Changes in the whole genome transciptome in cultured cells	Acute changes from baseline to 30 and/or 60 minutes.	Changes in the whole genome transciptome of cultured cells incubated with fasting and postprandial serum from participants receiving whey or fishmeal.

Secondary Outcome Measures

Name	Time	Method
Changes in cytokine secretion in cultured cell lines	Acute changes from baseline to 30 and/or 60 minutes.	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.
Changes in insulin-stimulated glucose uptake in cultured cell lines	Acute changes from baseline to 30 and/or 60 minutes.	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.
Blood concentration of glucose	Acute changes from baseline to 30 and 60 minutes	Blood concentration of glucose in participants receiving whey or fishmeal.
Blood concentration of triglycerides	Acute changes from baseline to 30 and 60 minutes	Blood concentration of triglycerides in participants receiving whey or fishmeal.
Changes in histone marks on selected target genes in cultured cell lines	Acute changes from baseline to 30 and/or 60 minutes.	Changes in histone marks on selected target genes in cultured cells incubated with fasting or postprandial serum from participants receiving whey or fishmeal.
Blood concentration of insulin	Acute changes from baseline to 30 and 60 minutes	Blood concentration of insulin in participants receiving whey or fishmeal.
Markers in blood related to appetite	Acute changes from baseline to 30 and 60 minutes	Blood concentration of the appetite hormones, i.e. GLP-1, Leptin and GIP in participants receiving whey or fishmeal.
Markers in blood related to low grade inflammation	Acute changes from baseline to 30 and 60 minutes	Blood concentration of microCRP in participants receiving whey or fishmeal.
Markers in blood related to digestion of protein	Acute changes from baseline to 30 and/or 60 minutes	Blood concentration of amino acids and small peptides in participants receiving whey or fishmeal.
Blood concentration of cholesterol	Acute changes from baseline to 30 and 60 minutes	Blood concentration of total cholesterol in participants receiving whey or fishmeal.

Trial Locations

Locations (1)

University of Oslo; 🇳🇴 Oslo, Norway