Muscle WeaknessGRIPENCT03529344
A Study on the Effects on Glucose Regulation, Inflammation and Serum Lipids After Fish Protein Supplementation in Elderly (GRIPE)
A study testing Blue whiting protein hydrolysate in people with Muscle Weakness and Muscle Loss, run by University of Bergen.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Muscle Weakness, Muscle Loss, Blood Sugar; High
- What is being tested?
- Blue whiting protein hydrolysate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >60 years
- both genders
- nursing home resident
Who cannot join
- life expectancy < 6 months
- severe cognitive impairment
- allergies towards fish, milk, egg
- weight loss >5% last 3 months
About this study
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
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.
Read the 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.
- Conditions
- Muscle Weakness, Muscle Loss, Blood Sugar; High, Inflammation, Aging
- Being tested
- Blue whiting protein hydrolysate, Placebo Comparator: Control
- Medical subject headings
- Muscle Weakness, Muscular Atrophy, Hyperglycemia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blue whiting protein hydrolysateDietary supplement
Dietary Supplement: Blue whiting protein hydrolysate 6g protein per day for 6wk
Placebo Comparator: ControlDietary supplement
Control group will receive non-caloric juice without protein supplementation
| Study group | Role | What they receive |
|---|---|---|
| Blue whiting protein hydrolysate | Active comparator | Dietary Supplement: Blue whiting protein hydrolysate 6g protein per day for 6wk Receives: Dietary Supplement: Blue whiting protein hydrolysate |
| Placebo Comparator: Control | Placebo comparator | Control group will receive non-caloric juice without protein supplementation Receives: Dietary Supplement: Placebo Comparator: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant compliance
Investigate the participant compliance based daily registrations by nursing home staff
Measured: 6 weeks
Participant dropout rate
Number of participants that completed the intervention period
Measured: 6 weeks
Secondary outcomes (5)
Glucose regulation
Glucose concentration will be measured in fasting serum
Measured: 6 weeks
Insulin
Insulin will be measured in fasting serum/plasma
Measured: 6 weeks
C-reactive protein in serum
C-reactive protein (a marker of inflammation) will be analysed in fasting serum
Measured: 6 weeks
Interleukin-6 in serum
Interleukin-6 (a marker of inflammation) will be analysed in fasting serum
Measured: 6 weeks
Monocyte chemoattractant protein-1 in serum
Monocyte chemoattractant protein-1 (a marker of inflammation) will be analysed in fasting serum
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study startAug 2016
- Primary completionDec 2018
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oddrun Anita Gudbrandsen, University of Bergen
- Investigators
- Oddrun A Gudbrandsen, PhD, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03529344
- Sponsor's protocol ID
- 2015/75
- Acronym
- GRIPE
- Status last verified
- Jan 2022
- First submitted
- 7 May 2018
- Last updated
- 4 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30858985
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03529344
- Acronym / sponsor ID
- GRIPE / 2015/75
- Conditions
- Muscle Weakness, Muscle Loss, Blood Sugar; High, Inflammation, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 18 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blue whiting protein hydrolysate | Active comparator | Dietary Supplement: Blue whiting protein hydrolysateDietary Supplement: Blue whiting protein hydrolysate 6g protein per day for 6wk |
| Placebo Comparator: Control | Placebo comparator | Dietary Supplement: Placebo Comparator: ControlControl group will receive non-caloric juice without protein supplementation |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >60 years
- both genders
- nursing home resident
Key exclusion criteria (4 listed)
- life expectancy < 6 months
- severe cognitive impairment
- allergies towards fish, milk, egg
- weight loss >5% last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blue whiting protein hydrolysateDietary Supplement: Blue whiting protein hydrolysate 6g protein per day for 6wk | Dietary supplement | Blue whiting protein hydrolysate |
| Placebo Comparator: ControlControl group will receive non-caloric juice without protein supplementation | Dietary supplement | Placebo Comparator: Control |
Primary outcome
Participant compliance
Time frame: 6 weeks
Investigate the participant compliance based daily registrations by nursing home staff
Participant dropout rate
Time frame: 6 weeks
Number of participants that completed the intervention period
5 secondary outcomes
Glucose regulation
Time frame: 6 weeks
Insulin
Time frame: 6 weeks
C-reactive protein in serum
Time frame: 6 weeks
Interleukin-6 in serum
Time frame: 6 weeks
Monocyte chemoattractant protein-1 in serum
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Results publication: PubMed 30858985Drotningsvik 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oddrun A Gudbrandsen, PhD principal investigator
University of Bergen
Questions about this trial
What is this clinical trial studying?
A study testing Blue whiting protein hydrolysate in people with Muscle Weakness and Muscle Loss, run by University of Bergen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant compliance (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03529344, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.