Effects of Salmon Fishmeal Ex Vivo (FishMeal Ex Vivo)
Primary Purpose
Metabolic Disease, Inflammation, Endocrine; Obesity
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Salmon fishmeal
Whey
Sponsored by
About this trial
This is an interventional basic science trial for Metabolic Disease
Eligibility Criteria
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.
Sites / Locations
- University of Oslo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Salmon fishmeal
Whey
Arm Description
5 g fishmeal in capsules, single oral dose
5 g whey in capsules, single oral dose
Outcomes
Primary Outcome Measures
Changes in the whole genome transciptome in cultured cells
Changes in the whole genome transciptome of cultured cells incubated with fasting and postprandial serum from participants receiving whey or fishmeal.
Secondary Outcome Measures
Changes in histone marks on selected target genes in cultured cell lines
Changes in histone marks on selected target genes in cultured cells incubated with fasting or postprandial serum from participants receiving whey or fishmeal.
Changes in insulin-stimulated glucose uptake in cultured cell lines
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
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
Blood concentration of insulin in participants receiving whey or fishmeal.
Blood concentration of glucose
Blood concentration of glucose in participants receiving whey or fishmeal.
Blood concentration of triglycerides
Blood concentration of triglycerides in participants receiving whey or fishmeal.
Blood concentration of cholesterol
Blood concentration of total cholesterol in participants receiving whey or fishmeal.
Markers in blood related to appetite
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
Blood concentration of microCRP in participants receiving whey or fishmeal.
Markers in blood related to digestion of protein
Blood concentration of amino acids and small peptides in participants receiving whey or fishmeal.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04078958
Brief Title
Effects of Salmon Fishmeal Ex Vivo (FishMeal Ex Vivo)
Official Title
Health Effects of Salmon Fish Meal - ex Vivo Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
November 7, 2019 (Actual)
Study Completion Date
November 7, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Disease, Inflammation, Endocrine; Obesity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Salmon fishmeal
Arm Type
Experimental
Arm Description
5 g fishmeal in capsules, single oral dose
Arm Title
Whey
Arm Type
Active Comparator
Arm Description
5 g whey in capsules, single oral dose
Intervention Type
Dietary Supplement
Intervention Name(s)
Salmon fishmeal
Intervention Description
Salmon fishmeal with high protein content
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey
Intervention Description
Whey with high protein content
Primary Outcome Measure Information:
Title
Changes in the whole genome transciptome in cultured cells
Description
Changes in the whole genome transciptome of cultured cells incubated with fasting and postprandial serum from participants receiving whey or fishmeal.
Time Frame
Acute changes from baseline to 30 and/or 60 minutes.
Secondary Outcome Measure Information:
Title
Changes in histone marks on selected target genes in cultured cell lines
Description
Changes in histone marks on selected target genes in cultured cells incubated with fasting or postprandial serum from participants receiving whey or fishmeal.
Time Frame
Acute changes from baseline to 30 and/or 60 minutes.
Title
Changes in insulin-stimulated glucose uptake in cultured cell lines
Description
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.
Time Frame
Acute changes from baseline to 30 and/or 60 minutes.
Title
Changes in cytokine secretion in cultured cell lines
Description
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.
Time Frame
Acute changes from baseline to 30 and/or 60 minutes.
Title
Blood concentration of insulin
Description
Blood concentration of insulin in participants receiving whey or fishmeal.
Time Frame
Acute changes from baseline to 30 and 60 minutes
Title
Blood concentration of glucose
Description
Blood concentration of glucose in participants receiving whey or fishmeal.
Time Frame
Acute changes from baseline to 30 and 60 minutes
Title
Blood concentration of triglycerides
Description
Blood concentration of triglycerides in participants receiving whey or fishmeal.
Time Frame
Acute changes from baseline to 30 and 60 minutes
Title
Blood concentration of cholesterol
Description
Blood concentration of total cholesterol in participants receiving whey or fishmeal.
Time Frame
Acute changes from baseline to 30 and 60 minutes
Title
Markers in blood related to appetite
Description
Blood concentration of the appetite hormones, i.e. GLP-1, Leptin and GIP in participants receiving whey or fishmeal.
Time Frame
Acute changes from baseline to 30 and 60 minutes
Title
Markers in blood related to low grade inflammation
Description
Blood concentration of microCRP in participants receiving whey or fishmeal.
Time Frame
Acute changes from baseline to 30 and 60 minutes
Title
Markers in blood related to digestion of protein
Description
Blood concentration of amino acids and small peptides in participants receiving whey or fishmeal.
Time Frame
Acute changes from baseline to 30 and/or 60 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsten Holven
Organizational Affiliation
University of Oslo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oslo
City
Oslo
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Salmon Fishmeal Ex Vivo (FishMeal Ex Vivo)
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