Effects of Salmon Fishmeal Ex Vivo (FishMeal Ex Vivo)

Inflammation Clinical Trial

Official title:

Health Effects of Salmon Fish Meal - ex Vivo Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04078958
• Other study ID #: 2019/875/REK sør-øst B
• Status: Completed
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: November 7, 2019

Study information

• Verified date: September 2021
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: November 7, 2019
• Est. primary completion date: November 7, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endocrine; Obesity
• Inflammation
• Metabolic Disease
• Metabolic Diseases

Intervention

Dietary Supplement:
• Salmon fishmeal
Salmon fishmeal with high protein content
• Whey
Whey with high protein content

Locations

Country	Name	City	State
Norway	University of Oslo	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	Blood concentration of insulin	Blood concentration of insulin in participants receiving whey or fishmeal.	Acute changes from baseline to 30 and 60 minutes
Secondary	Blood concentration of glucose	Blood concentration of glucose in participants receiving whey or fishmeal.	Acute changes from baseline to 30 and 60 minutes
Secondary	Blood concentration of triglycerides	Blood concentration of triglycerides in participants receiving whey or fishmeal.	Acute changes from baseline to 30 and 60 minutes
Secondary	Blood concentration of cholesterol	Blood concentration of total cholesterol in participants receiving whey or fishmeal.	Acute changes from baseline to 30 and 60 minutes
Secondary	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
Secondary	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
Secondary	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