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

NCT ID: NCT03529344

Last Updated: 2022-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2021-12-31

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.

Conditions

Muscle Weakness; Muscle Loss; Blood Sugar; High; Inflammation; Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Blue whiting protein hydrolysate

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

Group Type: ACTIVE_COMPARATOR

Blue whiting protein hydrolysate

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo Comparator: Control

Control group will receive non-caloric juice without protein supplementation

Group Type: PLACEBO_COMPARATOR

Placebo Comparator: Control

Intervention Type: DIETARY_SUPPLEMENT

Control group will receive non-caloric juice without protein supplementation

Interventions

Blue whiting protein hydrolysate

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo Comparator: Control

Control group will receive non-caloric juice without protein supplementation

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Bergen

OTHER

Sponsor Role: lead

Responsible Party

Oddrun Anita Gudbrandsen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oddrun A Gudbrandsen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Bergen

References

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.

Reference Type: RESULT

PMID: 30858985 (View on PubMed)

Other Identifiers

2015/75

Identifier Type: -

Identifier Source: org_study_id