Effects of Salmon Fishmeal Ex Vivo (FishMeal Ex Vivo)

Health Effects of Salmon Fish Meal - ex Vivo Study

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Metabolic Disease; Endocrine; Obesity
• Intervention / Treatment: Dietary supplement: Salmon fishmeal; Dietary supplement: Whey

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • University of Oslo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Salmon fishmeal; 5 g fishmeal in capsules, single oral dose	Dietary supplement: Salmon fishmeal; Salmon fishmeal with high protein content
Active Comparator: Whey; 5 g whey in capsules, single oral dose	Dietary supplement: Whey; Whey with high protein content

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Oslo
• Investigators: Principal Investigator: Kirsten Holven, University of Oslo

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2019
• Primary Completion (Actual): November 7, 2019
• Study Completion (Actual): November 7, 2019

Study Registration Dates

• First Submitted: August 29, 2019
• First Submitted That Met QC Criteria: September 2, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Metabolic Diseases
• Other Study ID Numbers: 2019/875/REK sør-øst B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No