Effects of Salmon Fishmeal Ex Vivo (FishMeal Ex Vivo)

NCT04078958 — Not applicable, Completed, 5 participants, University of Oslo

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Health Effects of Salmon Fish Meal - ex Vivo Study

Registry	NCT04078958
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: single, basic science
Enrollment	5 (Actual)
Sponsor	University of Oslo (Other)
Conditions	Metabolic Disease, Inflammation, Endocrine; Obesity
Interventions	Salmon fishmeal, Whey (Dietary supplement)
Dates	start 2019-10-15, primary completion 2019-11-07, completion 2019-11-07, first posted 2019-09-06, last updated 2021-09-28
Locations	1 site in Norway

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Salmon fishmeal	Experimental	Dietary Supplement: Salmon fishmeal	5 g fishmeal in capsules, single oral dose
Whey	Active comparator	Dietary Supplement: Whey	5 g whey in capsules, single oral dose

Salmon fishmeal (Dietary supplement): Salmon fishmeal with high protein content
Whey (Dietary supplement): Whey with high protein content

+Outcome measures

Primary outcomes

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 outcomes

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.
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.
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.
Blood concentration of insulin [Acute changes from baseline to 30 and 60 minutes]: Blood concentration of insulin in 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.
Blood concentration of cholesterol [Acute changes from baseline to 30 and 60 minutes]: Blood concentration of total cholesterol 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.

+Eligibility

Sex: All, ages: 20 Years to any, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
University of Oslo	Oslo	Norway

+Investigators

Kirsten Holven, Principal investigator, University of Oslo