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

Not Applicable

Completed

• Conditions: Inflammation; Muscle Weakness; Muscle Loss; Blood Sugar; High; Aging
• Interventions: Dietary Supplement: Blue whiting protein hydrolysate

• Registration Number: NCT03529344
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-08
• Study First Submitted: 2018-05-07
• Study First Submitted QC: 2018-05-17
• Study First Posted: 2018-05-18
• Primary Completion: 2018-12
• Study Completion: 2021-12
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-03
• Last Update Posted: 2022-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blue whiting protein hydrolysate	Blue whiting protein hydrolysate	Dietary Supplement: Blue whiting protein hydrolysate 6g protein per day for 6wk

Primary Outcome Measures

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

Secondary Outcome Measures

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