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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

Tracking Information
First Submitted Date  ICMJE June 29, 2018
First Posted Date  ICMJE December 5, 2018
Last Update Posted Date December 5, 2018
Actual Study Start Date  ICMJE September 14, 2018
Estimated Primary Completion Date May 3, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2018)
  • 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
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2018)
  • 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
  • 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
  • Blood concentration of HbA1c [ Time Frame: Changes in blood HbA1c concentration from baseline and after 8 weeks between groups ]
    Blood concentration measured fasting
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 3, 2018)
  • 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)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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)
  • 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)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Health Effects of Salmon Fishmeal in Humans
Official Title  ICMJE Health Effects of Salmon Fishmeal in Humans With Impaired Glucose Tolerance
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Impaired Glucose Tolerance
Intervention  ICMJE
  • Dietary Supplement: Salmon fishmeal
    Salmon fishmeal with high protein content
    Other Name: Fish protein
  • Dietary Supplement: Microcrystalline cellulose
    Microcrystalline cellulose contain no energy and is less fermented in the gut than other dietary fibers.
    Other Name: Cellulose
Study Arms  ICMJE
  • Experimental: Salmon fishmeal
    7,5 g fishmeal and 7,5 g microcrytalline cellulose per day in capsules by mounth for 8 weeks
    Intervention: Dietary Supplement: Salmon fishmeal
  • Placebo Comparator: Microcrystalline cellulose
    7,5 g microcrystalline cellulose per day in capsules by mounth for 8 weeks
    Intervention: Dietary Supplement: Microcrystalline cellulose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 3, 2018)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2019
Estimated Primary Completion Date May 3, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Kirsten Holven, professor 0047 22851361 k.b.holven@medisin.uio.no
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03764423
Other Study ID Numbers  ICMJE 901420
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kirsten Holven, University of Oslo
Study Sponsor  ICMJE University of Oslo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kirsten Holven, Professor University of Oslo
PRS Account University of Oslo
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP