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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04078958
Other study ID # 2019/875/REK sør-øst B
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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