Impaired Glucose Tolerance Clinical Trial
— FishMealOfficial title:
Health Effects of Salmon Fishmeal in Humans With Impaired Glucose Tolerance
Verified date | September 2021 |
Source | University of Oslo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Norway | University of Oslo | Oslo | Post Box 1046, Blindern |
Lead Sponsor | Collaborator |
---|---|
University of Oslo |
Norway,
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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