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Completed

NCT Number: NCT04078958

Effects of Salmon Fishmeal Ex Vivo (FishMeal Ex Vivo)

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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Key information

Conditions

Metabolic Disease Body Weight Endocrine; Obesity Inflammation Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oslo

Oslo, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Salmon fishmeal

Dietary Supplement

Salmon fishmeal with high protein content

Whey

Dietary Supplement

Whey with high protein content

Primary outcomes

  1. Changes in the whole genome transciptome in cultured cells

    Time frame: 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

  1. Changes in histone marks on selected target genes in cultured cell lines

    Time frame: 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.

  2. Changes in insulin-stimulated glucose uptake in cultured cell lines

    Time frame: 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.

  3. Changes in cytokine secretion in cultured cell lines

    Time frame: 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.

  4. Blood concentration of insulin

    Time frame: Acute changes from baseline to 30 and 60 minutes

    Blood concentration of insulin in participants receiving whey or fishmeal.

  5. Blood concentration of glucose

    Time frame: Acute changes from baseline to 30 and 60 minutes

    Blood concentration of glucose in participants receiving whey or fishmeal.

  6. Blood concentration of triglycerides

    Time frame: Acute changes from baseline to 30 and 60 minutes

    Blood concentration of triglycerides in participants receiving whey or fishmeal.

  7. Blood concentration of cholesterol

    Time frame: Acute changes from baseline to 30 and 60 minutes

    Blood concentration of total cholesterol in participants receiving whey or fishmeal.

  8. Markers in blood related to appetite

    Time frame: 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.

  9. Markers in blood related to low grade inflammation

    Time frame: Acute changes from baseline to 30 and 60 minutes

    Blood concentration of microCRP in participants receiving whey or fishmeal.

  10. Markers in blood related to digestion of protein

    Time frame: Acute changes from baseline to 30 and/or 60 minutes

    Blood concentration of amino acids and small peptides in participants receiving whey or fishmeal.

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Registry information

Official study title

Health Effects of Salmon Fish Meal - ex Vivo Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 6, 2019
Registry last updated
Sep 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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