Effect Study of Marine Protein Hydrolysates to Prevent Loss of Muscle Mass and Physical Function in Frail Elderly

NCT02890290 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2019-08-28

No results posted yet for this study

Summary

The purpose of this study is to determine whether a marine protein hydrolysate given as a supplement can prevent age related loss of muscle mass and loss of physical function in frail elderly. The study will recruit elderly living at home with help from municipal health care services, and a secondary goal of the study is to describe food habits, seafood intake and nutritional status in this group of patients.

Edit: the recruitment procedure was changed in august 2017, to include elderly without help from municipal health care services. Participants are now recruited trough media and organizations for elderly, and these changes in recruitment procedure was approved by the ethics committee august 2017.

Conditions

Interventions

DIETARY_SUPPLEMENT

Marine Protein hydrolysate

The participants will take the supplement in form of tablets and will be instructed to take five tablets twice a day, preferably in relation to meals, however, not the dinner meal. Each tablet contains 300 mg of marine protein hydrolysates (Nx6.25). The tablets are produced by Flexipharma AS.

DIETARY_SUPPLEMENT

Placebo

Placebo tablets will be made based on gum arabicum. The tablets are produced by Flexipharma AS.

Sponsors & Collaborators

  • Molde University College

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2019-07-31
Completion
2019-07-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02890290 on ClinicalTrials.gov