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

Aging Clinical Trial

— GRIPE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03529344
• Other study ID #: 2015/75
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: December 2021

Study information

• Verified date: January 2022
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Description:

Participants receive 6g per day of protein hydrolysate from blue whiting as protein powder mixed with a non-caloric juice for 6 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2021
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• Blue whiting protein hydrolysate
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Bergen

References & Publications (1)

Drotningsvik A, Oterhals Å, Flesland O, Nygård 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant compliance	Investigate the participant compliance based daily registrations by nursing home staff	6 weeks
Primary	Participant dropout rate	Number of participants that completed the intervention period	6 weeks
Secondary	Glucose regulation	Glucose concentration will be measured in fasting serum	6 weeks
Secondary	Insulin	Insulin will be measured in fasting serum/plasma	6 weeks
Secondary	C-reactive protein in serum	C-reactive protein (a marker of inflammation) will be analysed in fasting serum	6 weeks
Secondary	Interleukin-6 in serum	Interleukin-6 (a marker of inflammation) will be analysed in fasting serum	6 weeks
Secondary	Monocyte chemoattractant protein-1 in serum	Monocyte chemoattractant protein-1 (a marker of inflammation) will be analysed in fasting serum	6 weeks