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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03764423
Other study ID # 901420
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 14, 2018
Est. completion date November 1, 2019

Study information

Verified date September 2021
Source University of Oslo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date November 1, 2019
Est. primary completion date November 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Salmon fishmeal
Salmon fishmeal with high protein content
Microcrystalline cellulose
Microcrystalline cellulose contain no energy and is less fermented in the gut than other dietary fibers.

Locations

Country Name City State
Norway University of Oslo Oslo Post Box 1046, Blindern

Sponsors (1)

Lead Sponsor Collaborator
University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Other Markers related to lipid metabolism Blood concentrations of i.e. triglycerides, total-, LDL- and HDL- cholesterol, free fatty acids and lipoprotein subclasses (lipidomics) Changes in blood concentrations of markers related to lipid metabolism from baseline and after 8 weeks intervensjon
Other Markers related to low grade inflammation, including changes in genes expression level in peripheral blood mononuclear cell (PBMCs) in circulation Blood concentrations of i.e. CRP, IL-6 Changes in blood concentrations of markers related to inflammation from baseline and after 8 weeks between groups
Other Markers related to appetite Blood concentrations of gut hormones, i.e. PYY, amylin, leptin Changes in blood concentrations of markers related to appetite from baseline and after 8 weeks between groups
Other Changes in PBMC wholegenome transcriptome and untargeted metabolomics Blood or urine transcriptome and metabolomics Changes in blood concentration of PBMC wholegenome transcriptome and untargeted metabolomics from baseline and after 8 weeks whithin and between groups
Other Changes in markers related to gut microbiota Faecal short-chain fatty acids, bacteria type and diversity Changes in markers related to gut microbiota between groups from baseline and after 8 weeks intervensjon
Other Changes in blood concentration of micronutrients related to fishintake Blood concentrations of i.e. vitamin D, Zn, Se and iodine Changes in blood concentrations of micronutrients related to fishintake between groups from baseline and after 8 weeks intervensjon
Other Changes in blood concentration of amino acids Blood concentrations of different aminoacids such as i.e valine, isoleucine, leucine Changes in blood concentrations of amino acids between groups postprandially, and between baseline and 8 weeks of intervention
Other Body weight Bodyweight (kg) will be used to calculate i.e BMI (kg/m2) Change between groups from baseline and after 8 weeks intervensjon will be calculated
Other Height Height (m) will be used to calculate i.e. BMI (kg/m2) Change between groups from baseline and after 8 weeks intervensjon will be calculated
Primary 2 hour postprandial blood glucose concentration Glucose concentration measured before and after a standard glucose tolerance test at baseline and after 8 weeks Change in 2 hour blood glucose concentration from baseline and after 8 weeks between groups
Primary Fasting blood glucose concentration Measured at baseline and after 8 weeks. Change in blood glucose concentration from baseline and after 8 weeks between groups
Secondary Blood concentration of insulin Blood concentration measured fasting and 2 hours after an oral glucose tolerance test Changes in blood insulin concentration from baseline and after 8 weeks between groups
Secondary HOMA-IR 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 Changes in HOMAR-IR from baseline and after 8 weeks between groups
Secondary Blood concentration of HbA1c Blood concentration measured fasting Changes in blood HbA1c concentration from baseline and after 8 weeks between groups
Secondary Blood concentration of incretins (i.e. GLP-1) Blood concentration of incretins measured fasting and 2 hours after oral glucose tolerance test Changes in blood glucose concentration of increstins from baseline and after 8 weeks between groups
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