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Completed

NCT Number: NCT03764423

Health Effects of Salmon Fishmeal in Humans

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 the health beneficial effects of fish protein in the form of salmon fishmeal in a human intervention study with regard to metabolic risk markers.

We will include subjects with impaired glucose tolerance to a randomized controlled parallel study. The subjects will receive capsules with fishmeal or placebo.

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Key information

Conditions

Impaired Glucose Tolerance Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oslo

Oslo, Post Box 1046, Blindern, 0317, Norway

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Fasting plasma glucose ≥ 5.6 mmol/l or
  • Plasma glucose ≥ 6.5 mmol/l 2h after an OGTT or
  • HbA1c ≥ 5.8 %

Exclusion criteria

  • Diabetes (defined as p-glucose ≥ 7.0 mmol/l p-glucose ≥11,1 mmol/l 2h after OGTT or HbA1c ≥ 6.5 %)
  • High fish intake (> 450 gram/week) or fish allergy
  • Age-related elevated blood pressure (≥ 70 år: ≥ 180/110 mmHg, > 40-70: ≥ 170/100 mmHg and ≤ 40 år: ≥ 160/100 mmHg)
  • Use of prescription medicines related to diabetes, inflammation, systemic use of corticosteroids.
  • Non-stable use of lipid lowering drugs, thyroxine, blood pressure lowering drugs, drugs affecting appetite, dietary supplements (including n-3)
  • High intake of protein supplements powder
  • Pregnancy
  • Planning pregnancy or changes in body weight

Treatment and study plan

Salmon fishmeal

Dietary Supplement

Salmon fishmeal with high protein content

Other names: Fish protein

microcrystalline cellulose

Dietary Supplement

Microcrystalline cellulose contain no energy and is less fermented in the gut than other dietary fibers.

Other names: Cellulose

Primary outcomes

  1. 2 hour postprandial blood glucose concentration

    Time frame: Change in 2 hour blood glucose concentration from baseline and after 8 weeks between groups

    Glucose concentration measured before and after a standard glucose tolerance test at baseline and after 8 weeks

  2. Fasting blood glucose concentration

    Time frame: Change in blood glucose concentration from baseline and after 8 weeks between groups

    Measured at baseline and after 8 weeks.

Secondary outcomes

  1. Blood concentration of insulin

    Time frame: Changes in blood insulin concentration from baseline and after 8 weeks between groups

    Blood concentration measured fasting and 2 hours after an oral glucose tolerance test

  2. HOMA-IR

    Time frame: Changes in HOMAR-IR from baseline and after 8 weeks between groups

    Blood concentration of insulin x blood concentration of glucose will be used to calculate HOMAR-IR fasting and 2 hours after an oral glucose tolerance test

  3. Blood concentration of HbA1c

    Time frame: Changes in blood HbA1c concentration from baseline and after 8 weeks between groups

    Blood concentration measured fasting

  4. Blood concentration of incretins (i.e. GLP-1)

    Time frame: Changes in blood glucose concentration of increstins from baseline and after 8 weeks between groups

    Blood concentration of incretins measured fasting and 2 hours after oral glucose tolerance test

Other outcomes

  1. Markers related to lipid metabolism

    Time frame: Changes in blood concentrations of markers related to lipid metabolism from baseline and after 8 weeks intervensjon

    Blood concentrations of i.e. triglycerides, total-, LDL- and HDL- cholesterol, free fatty acids and lipoprotein subclasses (lipidomics)

  2. Markers related to low grade inflammation, including changes in genes expression level in peripheral blood mononuclear cell (PBMCs) in circulation

    Time frame: Changes in blood concentrations of markers related to inflammation from baseline and after 8 weeks between groups

    Blood concentrations of i.e. CRP, IL-6

  3. Markers related to appetite

    Time frame: Changes in blood concentrations of markers related to appetite from baseline and after 8 weeks between groups

    Blood concentrations of gut hormones, i.e. PYY, amylin, leptin

  4. Changes in PBMC wholegenome transcriptome and untargeted metabolomics

    Time frame: Changes in blood concentration of PBMC wholegenome transcriptome and untargeted metabolomics from baseline and after 8 weeks whithin and between groups

    Blood or urine transcriptome and metabolomics

  5. Changes in markers related to gut microbiota

    Time frame: Changes in markers related to gut microbiota between groups from baseline and after 8 weeks intervensjon

    Faecal short-chain fatty acids, bacteria type and diversity

  6. Changes in blood concentration of micronutrients related to fishintake

    Time frame: Changes in blood concentrations of micronutrients related to fishintake between groups from baseline and after 8 weeks intervensjon

    Blood concentrations of i.e. vitamin D, Zn, Se and iodine

  7. Changes in blood concentration of amino acids

    Time frame: Changes in blood concentrations of amino acids between groups postprandially, and between baseline and 8 weeks of intervention

    Blood concentrations of different aminoacids such as i.e valine, isoleucine, leucine

  8. Body weight

    Time frame: Change between groups from baseline and after 8 weeks intervensjon will be calculated

    Bodyweight (kg) will be used to calculate i.e BMI (kg/m2)

  9. Height

    Time frame: Change between groups from baseline and after 8 weeks intervensjon will be calculated

    Height (m) will be used to calculate i.e. BMI (kg/m2)

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Registry information

Official study title

Health Effects of Salmon Fishmeal in Humans With Impaired Glucose Tolerance

Acronym: FishMeal

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 5, 2018
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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