Back to resultsA Study on the Effects on Glucose Regulation, Inflammation and Serum Lipids After Fish Protein Supplementation in Elderly (GRIPE) (GRIPE)
Primary Purpose
Muscle Weakness, Muscle Loss, Blood Sugar; High
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Blue whiting protein hydrolysate
Placebo Comparator: Control
Sponsored by
About this trial
This is an interventional treatment trial for Muscle Weakness
Eligibility Criteria
Inclusion Criteria:
- >60 years
- both genders
- nursing home resident
Exclusion Criteria:
- life expectancy < 6 months
- severe cognitive impairment
- allergies towards fish, milk, egg
- weight loss >5% last 3 months
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Blue whiting protein hydrolysate
Placebo Comparator: Control
Arm Description
Dietary Supplement: Blue whiting protein hydrolysate 6g protein per day for 6wk
Control group will receive non-caloric juice without protein supplementation
Outcomes
Primary Outcome Measures
Participant compliance
Investigate the participant compliance based daily registrations by nursing home staff
Participant dropout rate
Number of participants that completed the intervention period
Secondary Outcome Measures
Glucose regulation
Glucose concentration will be measured in fasting serum
Insulin
Insulin will be measured in fasting serum/plasma
C-reactive protein in serum
C-reactive protein (a marker of inflammation) will be analysed in fasting serum
Interleukin-6 in serum
Interleukin-6 (a marker of inflammation) will be analysed in fasting serum
Monocyte chemoattractant protein-1 in serum
Monocyte chemoattractant protein-1 (a marker of inflammation) will be analysed in fasting serum
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03529344
Brief Title
A Study on the Effects on Glucose Regulation, Inflammation and Serum Lipids After Fish Protein Supplementation in Elderly (GRIPE)
Acronym
GRIPE
Official Title
A 6-week Pilot Study to Investigate the Effects of Protein Hydrolysate From Blue Whiting on Glucose Regulation, Inflammation and Serum Lipids in Elderly Nursing Home Residents From Western Norway
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bergen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The elderly population have and increased risk of loss of both muscle mass and function and is therefore recommended a higher protein intake than the healthy adult population. These age-related changes in muscle function may be explained by chronic low-grade inflammation and insulin resistance. Despite the recommendation of a higher protein intake, little is known about how different protein sources may affect the metabolic health in this population. Analysis of amino acid composition show that fish can be a good protein source for humans. Many fish species are today used as feed ingredients, rather than a protein source for humans. A few studies conducted in humans and rats show that proteins from fish may improve glucose tolerance, reduce inflammation and improve lipid metabolism, indicating that proteins from fish may not only serve as a valuable nutrient but could also hold specific health promoting properties.
The present study will investigate the effects of a protein hydrolysate from blue whiting, a fish species normally used to produce fish meal for aquaculture industry, on glucose homeostasis, inflammation and serum lipids in elderly nursing home residents.
Detailed Description
Participants receive 6g per day of protein hydrolysate from blue whiting as protein powder mixed with a non-caloric juice for 6 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness, Muscle Loss, Blood Sugar; High, Inflammation, Aging
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Blue whiting protein hydrolysate
Arm Type
Active Comparator
Arm Description
Dietary Supplement: Blue whiting protein hydrolysate 6g protein per day for 6wk
Arm Title
Placebo Comparator: Control
Arm Type
Placebo Comparator
Arm Description
Control group will receive non-caloric juice without protein supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
Blue whiting protein hydrolysate
Intervention Description
Dietary Supplement: Blue whiting protein hydrolysate 6g protein per day for 6wk
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Comparator: Control
Intervention Description
Control group will receive non-caloric juice without protein supplementation
Primary Outcome Measure Information:
Title
Participant compliance
Description
Investigate the participant compliance based daily registrations by nursing home staff
Time Frame
6 weeks
Title
Participant dropout rate
Description
Number of participants that completed the intervention period
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Glucose regulation
Description
Glucose concentration will be measured in fasting serum
Time Frame
6 weeks
Title
Insulin
Description
Insulin will be measured in fasting serum/plasma
Time Frame
6 weeks
Title
C-reactive protein in serum
Description
C-reactive protein (a marker of inflammation) will be analysed in fasting serum
Time Frame
6 weeks
Title
Interleukin-6 in serum
Description
Interleukin-6 (a marker of inflammation) will be analysed in fasting serum
Time Frame
6 weeks
Title
Monocyte chemoattractant protein-1 in serum
Description
Monocyte chemoattractant protein-1 (a marker of inflammation) will be analysed in fasting serum
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
>60 years
both genders
nursing home resident
Exclusion Criteria:
life expectancy < 6 months
severe cognitive impairment
allergies towards fish, milk, egg
weight loss >5% last 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oddrun A Gudbrandsen, PhD
Organizational Affiliation
University of Bergen
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
30858985
Citation
Drotningsvik A, Oterhals A, Flesland O, Nygard O, Gudbrandsen OA. Fish protein supplementation in older nursing home residents: a randomised, double-blind, pilot study. Pilot Feasibility Stud. 2019 Feb 26;5:35. doi: 10.1186/s40814-019-0421-x. eCollection 2019.
Results Reference
result
Learn more about this trial
A Study on the Effects on Glucose Regulation, Inflammation and Serum Lipids After Fish Protein Supplementation in Elderly (GRIPE)
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