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
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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