Introduction Age-related loss of muscle mass, muscle strength and muscle function (sarcopenia) leads to a decline in physical performance, loss of independence and reduced quality of life. Nutritional supplements may delay the progression of sarcopenia. The aim of this randomised, double-blinded controlled trial including 100 participants (≥65 years) is to assess the effect of a marine protein hydrolysate (MPH) on sarcopenia-related outcomes like hand grip strength, physical performance or gait speed and to study the associations between physical performance and nutritional intake and status.
Method and analysis The intervention group (n=50) will receive 3 g of MPH per day in 12 months. The control group (n=50) receive placebo. Assessments of Short Physical Performance Battery (SPPB), hand grip strength, anthropometric measurements, nutritional status as measured by the Mini Nutritional Assessment, dietary intake, supplement use, biomarkers of protein nutrition and vitamin D, and health-related quality of life (EQ-5D), will be performed at baseline and after 6 and 12 months of intervention. Linear mixed models will be estimated to assess the effect of MPH on SPPB, hand grip strength and quality of life, as well as associations between physical performance and nutrition.
Ethics and dissemination The study has been approved by the Regional Committee in Ethics in Medical Research in Mid-Norway in September 2016 with the registration ID 2016/1152. The results will be actively disseminated through peer-reviewed journals, conference presentations, social media, broadcast media and print media.
Trial registration number NCT02890290.
- geriatric medicine
- preventive medicine
- primary care
- public health
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Contributors LAKN is responsible for the study. LAKN, AMMR, LD and IM developed the study design. JŠB planned and will perform the statistical analyses. LAKN drafted the manuscript, and AMMR, IM, LD and JŠB took part in the writing process. All authors have read and approved the final version of the manuscript.
Funding The project is funded by a general PhD grant from Molde University College. Blood analyses are funded by The Research Council of Norway, Programme for Regional R&D and Innovation (VRI). The intervention is funded by Firmenich Bjørge Biomarin AS, which provided the marine protein hydrolysate supplement and placebo preparation.
Competing interests None declared.
Patient consent Not required.
Ethics approval The study will be conducted in accordance with the Declaration of Helsinki and was approved by the Regional Committee on Ethics in Medical Research in Mid-Norway in September 2016 with the registration ID 2016/1152.
Provenance and peer review Not commissioned; externally peer reviewed.
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