NCT03529344

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 18, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 4, 2022

Status Verified

January 1, 2022

Enrollment Period

2.3 years

First QC Date

May 7, 2018

Last Update Submit

January 3, 2022

Conditions

Muscle WeaknessMuscle LossBlood Sugar; HighInflammationAging

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Glucose regulation

    6 weeks

  • Insulin

    6 weeks

  • C-reactive protein in serum

    6 weeks

  • Interleukin-6 in serum

    6 weeks

  • Monocyte chemoattractant protein-1 in serum

    6 weeks

Study Arms (2)

Blue whiting protein hydrolysate

ACTIVE COMPARATOR

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

Dietary Supplement: Blue whiting protein hydrolysate

Placebo Comparator: Control

PLACEBO COMPARATOR

Control group will receive non-caloric juice without protein supplementation

Dietary Supplement: Placebo Comparator: Control

Interventions

Blue whiting protein hydrolysateDIETARY_SUPPLEMENT

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

Blue whiting protein hydrolysate
Placebo Comparator: ControlDIETARY_SUPPLEMENT

Control group will receive non-caloric juice without protein supplementation

Placebo Comparator: Control

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>60 years
  • both genders
  • nursing home resident

You may not qualify if:

  • life expectancy \< 6 months
  • severe cognitive impairment
  • allergies towards fish, milk, egg
  • weight loss \>5% last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 30858985RESULT

MeSH Terms

Conditions

Muscle WeaknessMuscular AtrophyHyperglycemiaInflammation

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsAtrophyPathological Conditions, AnatomicalGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Oddrun A Gudbrandsen, PhD

    University of Bergen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 7, 2018

First Posted

May 18, 2018

Study Start

August 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2021

Last Updated

January 4, 2022

Record last verified: 2022-01