Effect of immuno-nutrition on markers of sarcopenia and systemic inflammation in a haemodialysis population: a feasibility randomised controlled trial.

Research question What is the feasibility of conducting a randomised trial of immuno-nutrition compared to conventional oral nutritional supplements (ONS) in people receiving haemodialysis, to assess the impact on markers of sarcopenia, systemic inflammation and health-related quality of life (HRQoL)? Background Sarcopenia is much more prevalent and severe in people receiving haemodialysis than the general population, and has a major impact on HRQoL, need for hospitalisation, healthcare expenditure and survival. Although the problem of sarcopenia in haemodialysis is widely acknowledged, dietetic support and conventional ONS are not effective at improving markers of sarcopenia, likely because systemic inflammation attenuates the anabolic effects of dietary protein. To address this problem, we propose to use an immuno-nutrition supplement to simultaneously reduce systemic inflammation and support nutritional intake. Objectives Primary objectives: To assess the feasibility of recruitment and randomisation to the trial, as well as adherence, safety and acceptability of the intervention. To evaluate feasibility of conducting the trial at two sites. To assess the effect of different durations of intervention to identify the optimum period for a future trial. To determine the optimal primary endpoint for a future trial. Secondary objectives: To investigate the effect of immuno-nutrition on muscle strength, body composition, physical performance, prevalence of sarcopenia, dietary intake, biochemical blood variables, inflammatory markers, and HRQoL. Methods This will be a two-centre, feasibility randomised controlled trial; participants will be randomly allocated to the control group (conventional ONS, n=35) or the intervention group (immuno-nutrition, n=35). Both groups will take one supplement dose daily for 24 weeks. We will collect feasibility outcomes including screening, eligibility, consent, approach, randomisation and completion rates. At each study visit, we will assess secondary outcomes and adherence, acceptability and safety of the intervention. Study visits will include the following assessments at baseline, 12, 18 and 24 weeks: Handgrip strength using a digital dynamometer Body composition via bioelectrical impedance analysis Physical performance using the Short Physical Performance Battery Prevalence of sarcopenia using the consensus definition from the European Working Group on Sarcopenia in Older People Dietary intake via food diaries Pre-dialysis blood samples for analysis of systemic inflammation, waste products, electrolytes, haemoglobin and proteins. HRQoL using the Kidney Disease Quality of Life 36-item short-form survey Timelines for delivery Months 0-7: obtaining study approvals and study site set up; Months 7-24: study recruitment, follow-up assessments, data input and analysis; Month 25 and post-grant: dissemination activities and writing of reports, manuscripts and future funding application. Impact and Dissemination Results will be presented at scientific conferences and submitted to peer-reviewed journals for publication. We will ask our PPIE group for advice on design and format of dissemination activities for participants and the wider patient and public body. We will also share our results with professional and patient organisations. If we confirm feasibility, we will use the data collected to design a definitive trial. If this shows clinical efficacy, immuno-nutrition can be expected to improve HRQoL, reduce hospitalisations, increase independence and consequently lower both health and social care use/costs, as well as prolong survival.