Clinical trial NCT04078958: Effects of Salmon Fishmeal Ex Vivo (FishMeal Ex Vivo)
Official title: Health Effects of Salmon Fish Meal - ex Vivo Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Disease
Inflammation
Endocrine; Obesity
Lead sponsor: University of Oslo
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 5
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in the whole genome transciptome in cultured cells
timeFrame: Acute changes from baseline to 30 and/or 60 minutes.
Secondary outcomes:
measure: Changes in histone marks on selected target genes in cultured cell lines
timeFrame: Acute changes from baseline to 30 and/or 60 minutes.
measure: Changes in insulin-stimulated glucose uptake in cultured cell lines
timeFrame: Acute changes from baseline to 30 and/or 60 minutes.
measure: Changes in cytokine secretion in cultured cell lines
timeFrame: Acute changes from baseline to 30 and/or 60 minutes.
measure: Blood concentration of insulin
timeFrame: Acute changes from baseline to 30 and 60 minutes
measure: Blood concentration of glucose
timeFrame: Acute changes from baseline to 30 and 60 minutes
measure: Blood concentration of triglycerides
timeFrame: Acute changes from baseline to 30 and 60 minutes
measure: Blood concentration of cholesterol
timeFrame: Acute changes from baseline to 30 and 60 minutes
measure: Markers in blood related to appetite
timeFrame: Acute changes from baseline to 30 and 60 minutes
measure: Markers in blood related to low grade inflammation
timeFrame: Acute changes from baseline to 30 and 60 minutes
measure: Markers in blood related to digestion of protein
timeFrame: Acute changes from baseline to 30 and/or 60 minutes
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: University of Oslo
Study officials:
affiliation: University of Oslo
name: Kirsten Holven
role: PRINCIPAL_INVESTIGATOR
References: