Metabolic Disease, Inflammation, Endocrine; Obesity
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 physiological and molecular effects of fish protein in the form of salmon fishmeal compared to whey in a human intervention study with regard to carbohydrate- and fat metabolism, endocrine factors and inflammation. The investigators will include healthy subjects to a randomized controlled cross over study. The subjects will receive a single, oral dose of fishmeal or whey. Blood samples are taken before (fasting) and 30 and 60 minutes after intake. The molecular effects of fishmeal and whey are investigated ex vivo. This is done by incubating human cell lines (i.e hepatocytes, adipocytes, epithelial cells) with fasting and postprandial serum from the participants.
Interventions
DIETARY_SUPPLEMENTSalmon fishmeal
Salmon fishmeal with high protein content
DIETARY_SUPPLEMENTWhey
Whey with high protein content
Sponsors
University of Oslo
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Body mass index 18.5-24.9 kg/m2
Exclusion criteria
* Body mass index \<18.5 or \>24.9 kg/m2 * Known diabetes or high blood pressure * Pregnancy or breast feeding * Allergy or intolerance to dairy or fish/fish protein.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the whole genome transciptome in cultured cells | Acute changes from baseline to 30 and/or 60 minutes. | Changes in the whole genome transciptome of cultured cells incubated with fasting and postprandial serum from participants receiving whey or fishmeal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in insulin-stimulated glucose uptake in cultured cell lines | Acute changes from baseline to 30 and/or 60 minutes. | Changes in insulin sensitivity measured as insulin-stimulated glucose uptake of cultured cells incubated with fasting and postprandial serum from participants receiving whey or fishmeal. |
| Changes in cytokine secretion in cultured cell lines | Acute changes from baseline to 30 and/or 60 minutes. | Changes in inflammatory and endocrine factors measured as the secretion of single cytokines from cultured cells incubated with fasting and postprandial serum from participants receiving whey or fishmeal. The choice of factors will be guided by the results from the primary endpoint. |
| Blood concentration of insulin | Acute changes from baseline to 30 and 60 minutes | Blood concentration of insulin in participants receiving whey or fishmeal. |
| Blood concentration of glucose | Acute changes from baseline to 30 and 60 minutes | Blood concentration of glucose in participants receiving whey or fishmeal. |
| Changes in histone marks on selected target genes in cultured cell lines | Acute changes from baseline to 30 and/or 60 minutes. | Changes in histone marks on selected target genes in cultured cells incubated with fasting or postprandial serum from participants receiving whey or fishmeal. |
| Blood concentration of cholesterol | Acute changes from baseline to 30 and 60 minutes | Blood concentration of total cholesterol in participants receiving whey or fishmeal. |
| Markers in blood related to appetite | Acute changes from baseline to 30 and 60 minutes | Blood concentration of the appetite hormones, i.e. GLP-1, Leptin and GIP in participants receiving whey or fishmeal. |
| Markers in blood related to low grade inflammation | Acute changes from baseline to 30 and 60 minutes | Blood concentration of microCRP in participants receiving whey or fishmeal. |
| Markers in blood related to digestion of protein | Acute changes from baseline to 30 and/or 60 minutes | Blood concentration of amino acids and small peptides in participants receiving whey or fishmeal. |
| Blood concentration of triglycerides | Acute changes from baseline to 30 and 60 minutes | Blood concentration of triglycerides in participants receiving whey or fishmeal. |
Countries
Norway
Outcome results
None listed