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

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Muscle Weakness; Aging; Muscle Loss; Blood Sugar; High
• Intervention / Treatment: Dietary supplement: Blue whiting protein hydrolysate; Dietary supplement: Placebo Comparator: Control

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 58 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant compliance	Investigate the participant compliance based daily registrations by nursing home staff	6 weeks
Participant dropout rate	Number of participants that completed the intervention period	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose regulation	Glucose concentration will be measured in fasting serum	6 weeks
Insulin	Insulin will be measured in fasting serum/plasma	6 weeks
C-reactive protein in serum	C-reactive protein (a marker of inflammation) will be analysed in fasting serum	6 weeks
Interleukin-6 in serum	Interleukin-6 (a marker of inflammation) will be analysed in fasting serum	6 weeks
Monocyte chemoattractant protein-1 in serum	Monocyte chemoattractant protein-1 (a marker of inflammation) will be analysed in fasting serum	6 weeks

Collaborators and Investigators

• Sponsor: University of Bergen
• Investigators: Principal Investigator: Oddrun A Gudbrandsen, PhD, University of Bergen

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: May 7, 2018
• First Submitted That Met QC Criteria: May 17, 2018
• First Posted (Actual): May 18, 2018

Study Record Updates

• Last Update Posted (Actual): January 4, 2022
• Last Update Submitted That Met QC Criteria: January 3, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Hyperglycemia; Inflammation; Muscle Weakness
• Other Study ID Numbers: 2015/75

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No