Impaired Glucose Tolerance
Conditions
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.
Interventions
DIETARY_SUPPLEMENTSalmon fishmeal
Salmon fishmeal with high protein content
DIETARY_SUPPLEMENTMicrocrystalline cellulose
Microcrystalline cellulose contain no energy and is less fermented in the gut than other dietary fibers.
Sponsors
University of Oslo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2 hour postprandial blood glucose concentration | 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 | Change in blood glucose concentration from baseline and after 8 weeks between groups | Measured at baseline and after 8 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood concentration of insulin | 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 | 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 | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in blood concentration of amino acids | 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 |
| Markers related to lipid metabolism | 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) |
| Height | 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) |
| Body weight | 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) |
| Markers related to low grade inflammation, including changes in genes expression level in peripheral blood mononuclear cell (PBMCs) in circulation | 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 | 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 | 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 | 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 | 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 |
Countries
Norway
Outcome results
None listed