Nutrition and physical performance in older people-effects of marine protein hydrolysates to prevent decline in physical performance: a randomised controlled trial protocol.

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.