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Health Effects of Salmon Fishmeal in Humans (FishMeal)

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ClinicalTrials.gov Identifier: NCT03764423
Recruitment Status : Recruiting
First Posted : December 5, 2018
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Kirsten Holven, University of Oslo

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 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.


Condition or disease Intervention/treatment Phase
Impaired Glucose Tolerance Dietary Supplement: Salmon fishmeal Dietary Supplement: Microcrystalline cellulose Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Health Effects of Salmon Fishmeal in Humans With Impaired Glucose Tolerance
Actual Study Start Date : September 14, 2018
Estimated Primary Completion Date : May 3, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Salmon fishmeal
7,5 g fishmeal and 7,5 g microcrytalline cellulose per day in capsules by mounth for 8 weeks
Dietary Supplement: Salmon fishmeal
Salmon fishmeal with high protein content
Other Name: Fish protein

Placebo Comparator: Microcrystalline cellulose
7,5 g microcrystalline cellulose per day in capsules by mounth for 8 weeks
Dietary Supplement: Microcrystalline cellulose
Microcrystalline cellulose contain no energy and is less fermented in the gut than other dietary fibers.
Other Name: Cellulose




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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)



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03764423


Contacts
Contact: Kirsten Holven, professor 0047 22851361 k.b.holven@medisin.uio.no

Locations
Norway
University of Oslo Recruiting
Oslo, Post Box 1046, Blindern, Norway, 0317
Contact: Kirsten Bjørklund Holven, Professor    +47 22851361    kirsten.holven@medisin.uio.no   
Sponsors and Collaborators
University of Oslo
Investigators
Principal Investigator: Kirsten Holven, Professor University of Oslo

Responsible Party: Kirsten Holven, Professor, University of Oslo
ClinicalTrials.gov Identifier: NCT03764423     History of Changes
Other Study ID Numbers: 901420
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Glucose Intolerance
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases