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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Salmon fishmeal | Experimental | 7,5 g fishmeal and 7,5 g microcrytalline cellulose per day in capsules by mounth for 8 weeks |
|
| Microcrystalline cellulose | Placebo Comparator | 7,5 g microcrystalline cellulose per day in capsules by mounth for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salmon fishmeal | Dietary Supplement | Salmon fishmeal with high protein content |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Fasting blood glucose concentration | Measured at baseline and after 8 weeks. | Change in blood glucose concentration from baseline and after 8 weeks between groups |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| HOMA-IR |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Markers related to low grade inflammation, including changes in genes expression level in peripheral blood mononuclear cell (PBMCs) in circulation |
Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kirsten Holven, Professor | University of Oslo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oslo | Oslo | Post Box 1046, Blindern | 0317 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35362766 | Derived | Hustad KS, Ottestad I, Olsen T, Saether T, Ulven SM, Holven KB. Salmon fish protein supplement increases serum vitamin B12 and selenium concentrations: secondary analysis of a randomised controlled trial. Eur J Nutr. 2022 Sep;61(6):3085-3093. doi: 10.1007/s00394-022-02857-4. Epub 2022 Apr 1. |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D029941 | Fish Proteins |
| C109691 | microcrystalline cellulose |
| D002482 | Cellulose |
| ID | Term |
|---|---|
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005936 | Glucans |
| D001704 | Biopolymers |
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| Microcrystalline cellulose | Dietary Supplement | Microcrystalline cellulose contain no energy and is less fermented in the gut than other dietary fibers. |
|
|
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 |
| Blood concentration of HbA1c | Blood concentration measured fasting | Changes in blood HbA1c concentration from baseline and after 8 weeks between groups |
| 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 |
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| D011108 |
| Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |