Clinical trial NCT03529344: A Study on the Effects on Glucose Regulation, Inflammation and Serum Lipids After Fish Protein Supplementation in Elderly (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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Weakness
Muscle Loss
Blood Sugar; High
Inflammation
Aging
Lead sponsor: University of Bergen
Sponsor class: OTHER
First posted: 2018-05-18
Enrollment: 24
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Participant compliance
timeFrame: 6 weeks
measure: Participant dropout rate
timeFrame: 6 weeks
Secondary outcomes:
measure: Glucose regulation
timeFrame: 6 weeks
measure: Insulin
timeFrame: 6 weeks
measure: C-reactive protein in serum
timeFrame: 6 weeks
measure: Interleukin-6 in serum
timeFrame: 6 weeks
measure: Monocyte chemoattractant protein-1 in serum
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Bergen
name: Oddrun A Gudbrandsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.