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Health Effects of Salmon Fishmeal in Humans (FishMeal)

Primary Purpose

Impaired Glucose Tolerance

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Salmon fishmeal
Microcrystalline cellulose
Sponsored by
University of Oslo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impaired Glucose Tolerance

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Oslo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Salmon fishmeal

Microcrystalline cellulose

Arm Description

7,5 g fishmeal and 7,5 g microcrytalline cellulose per day in capsules by mounth for 8 weeks

7,5 g microcrystalline cellulose per day in capsules by mounth for 8 weeks

Outcomes

Primary Outcome Measures

2 hour postprandial blood glucose concentration
Glucose concentration measured before and after a standard glucose tolerance test at baseline and after 8 weeks
Fasting blood glucose concentration
Measured at baseline and after 8 weeks.

Secondary Outcome Measures

Blood concentration of insulin
Blood concentration measured fasting and 2 hours after an oral glucose tolerance test
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
Blood concentration of HbA1c
Blood concentration measured fasting
Blood concentration of incretins (i.e. GLP-1)
Blood concentration of incretins measured fasting and 2 hours after oral glucose tolerance test

Full Information

First Posted
June 29, 2018
Last Updated
September 27, 2021
Sponsor
University of Oslo
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1. Study Identification

Unique Protocol Identification Number
NCT03764423
Brief Title
Health Effects of Salmon Fishmeal in Humans
Acronym
FishMeal
Official Title
Health Effects of Salmon Fishmeal in Humans With Impaired Glucose Tolerance
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 14, 2018 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
November 1, 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impaired Glucose Tolerance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Salmon fishmeal
Arm Type
Experimental
Arm Description
7,5 g fishmeal and 7,5 g microcrytalline cellulose per day in capsules by mounth for 8 weeks
Arm Title
Microcrystalline cellulose
Arm Type
Placebo Comparator
Arm Description
7,5 g microcrystalline cellulose per day in capsules by mounth for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Salmon fishmeal
Other Intervention Name(s)
Fish protein
Intervention Description
Salmon fishmeal with high protein content
Intervention Type
Dietary Supplement
Intervention Name(s)
Microcrystalline cellulose
Other Intervention Name(s)
Cellulose
Intervention Description
Microcrystalline cellulose contain no energy and is less fermented in the gut than other dietary fibers.
Primary Outcome Measure Information:
Title
2 hour postprandial blood glucose concentration
Description
Glucose concentration measured before and after a standard glucose tolerance test at baseline and after 8 weeks
Time Frame
Change in 2 hour blood glucose concentration from baseline and after 8 weeks between groups
Title
Fasting blood glucose concentration
Description
Measured at baseline and after 8 weeks.
Time Frame
Change in blood glucose concentration from baseline and after 8 weeks between groups
Secondary Outcome Measure Information:
Title
Blood concentration of insulin
Description
Blood concentration measured fasting and 2 hours after an oral glucose tolerance test
Time Frame
Changes in blood insulin concentration from baseline and after 8 weeks between groups
Title
HOMA-IR
Description
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
Time Frame
Changes in HOMAR-IR from baseline and after 8 weeks between groups
Title
Blood concentration of HbA1c
Description
Blood concentration measured fasting
Time Frame
Changes in blood HbA1c concentration from baseline and after 8 weeks between groups
Title
Blood concentration of incretins (i.e. GLP-1)
Description
Blood concentration of incretins measured fasting and 2 hours after oral glucose tolerance test
Time Frame
Changes in blood glucose concentration of increstins from baseline and after 8 weeks between groups
Other Pre-specified Outcome Measures:
Title
Markers related to lipid metabolism
Description
Blood concentrations of i.e. triglycerides, total-, LDL- and HDL- cholesterol, free fatty acids and lipoprotein subclasses (lipidomics)
Time Frame
Changes in blood concentrations of markers related to lipid metabolism from baseline and after 8 weeks intervensjon
Title
Markers related to low grade inflammation, including changes in genes expression level in peripheral blood mononuclear cell (PBMCs) in circulation
Description
Blood concentrations of i.e. CRP, IL-6
Time Frame
Changes in blood concentrations of markers related to inflammation from baseline and after 8 weeks between groups
Title
Markers related to appetite
Description
Blood concentrations of gut hormones, i.e. PYY, amylin, leptin
Time Frame
Changes in blood concentrations of markers related to appetite from baseline and after 8 weeks between groups
Title
Changes in PBMC wholegenome transcriptome and untargeted metabolomics
Description
Blood or urine transcriptome and metabolomics
Time Frame
Changes in blood concentration of PBMC wholegenome transcriptome and untargeted metabolomics from baseline and after 8 weeks whithin and between groups
Title
Changes in markers related to gut microbiota
Description
Faecal short-chain fatty acids, bacteria type and diversity
Time Frame
Changes in markers related to gut microbiota between groups from baseline and after 8 weeks intervensjon
Title
Changes in blood concentration of micronutrients related to fishintake
Description
Blood concentrations of i.e. vitamin D, Zn, Se and iodine
Time Frame
Changes in blood concentrations of micronutrients related to fishintake between groups from baseline and after 8 weeks intervensjon
Title
Changes in blood concentration of amino acids
Description
Blood concentrations of different aminoacids such as i.e valine, isoleucine, leucine
Time Frame
Changes in blood concentrations of amino acids between groups postprandially, and between baseline and 8 weeks of intervention
Title
Body weight
Description
Bodyweight (kg) will be used to calculate i.e BMI (kg/m2)
Time Frame
Change between groups from baseline and after 8 weeks intervensjon will be calculated
Title
Height
Description
Height (m) will be used to calculate i.e. BMI (kg/m2)
Time Frame
Change between groups from baseline and after 8 weeks intervensjon will be calculated

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsten Holven, Professor
Organizational Affiliation
University of Oslo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oslo
City
Oslo
State/Province
Post Box 1046, Blindern
ZIP/Postal Code
0317
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35362766
Citation
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.
Results Reference
derived

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Health Effects of Salmon Fishmeal in Humans

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