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A Study on the Effects on Glucose Regulation, Inflammation and Serum Lipids After Fish Protein Supplementation in Elderly (GRIPE) (GRIPE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03529344
Recruitment Status : Active, not recruiting
First Posted : May 18, 2018
Last Update Posted : March 30, 2020
Sponsor:
Information provided by (Responsible Party):
Oddrun Anita Gudbrandsen, University of Bergen

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.


Condition or disease Intervention/treatment Phase
Muscle Weakness Muscle Loss Blood Sugar; High Inflammation Aging Dietary Supplement: Blue whiting protein hydrolysate Dietary Supplement: Placebo Comparator: Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 2016
Actual Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nursing Homes

Arm Intervention/treatment
Active Comparator: Blue whiting protein hydrolysate
Dietary Supplement: Blue whiting protein hydrolysate 6g protein per day for 6wk
Dietary Supplement: Blue whiting protein hydrolysate
Dietary Supplement: Blue whiting protein hydrolysate 6g protein per day for 6wk

Placebo Comparator: Placebo Comparator: Control
Control group will receive non-caloric juice without protein supplementation
Dietary Supplement: Placebo Comparator: Control
Control group will receive non-caloric juice without protein supplementation




Primary Outcome Measures :
  1. Participant compliance [ Time Frame: 6 weeks ]
    Investigate the participant compliance based daily registrations by nursing home staff

  2. Participant dropout rate [ Time Frame: 6 weeks ]
    Number of participants that completed the intervention period


Secondary Outcome Measures :
  1. Glucose regulation [ Time Frame: 6 weeks ]
    Glucose concentration will be measured in fasting serum

  2. Insulin [ Time Frame: 6 weeks ]
    Insulin will be measured in fasting serum/plasma

  3. C-reactive protein in serum [ Time Frame: 6 weeks ]
    C-reactive protein (a marker of inflammation) will be analysed in fasting serum

  4. Interleukin-6 in serum [ Time Frame: 6 weeks ]
    Interleukin-6 (a marker of inflammation) will be analysed in fasting serum

  5. Monocyte chemoattractant protein-1 in serum [ Time Frame: 6 weeks ]
    Monocyte chemoattractant protein-1 (a marker of inflammation) will be analysed in fasting serum



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529344


Sponsors and Collaborators
University of Bergen
Investigators
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Principal Investigator: Oddrun A Gudbrandsen, PhD University of Bergen
Publications of Results:
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Responsible Party: Oddrun Anita Gudbrandsen, Principal Investigator, University of Bergen
ClinicalTrials.gov Identifier: NCT03529344    
Other Study ID Numbers: 2015/75
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Muscle Weakness
Hyperglycemia
Inflammation
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Glucose Metabolism Disorders
Metabolic Diseases