Effect of immuno-nutrition on markers of sarcopenia and systemic inflammation in a haemodialysis population: a feasibility randomised controlled trial
Renal failure
This is a feasibility study that will be conducted in the Royal Derby Hospital renal dialysis unit and Lichfield dialysis centre. Participants will be randomly assigned (similar to picking names from a hat) to the intervention group (“immuno-nutrition”) or the usual care group (standard food supplement). Both groups will take one supplement daily for 24 weeks. Potential participants will be identified by members of the usual healthcare team (which may include members of the research team). Then, a member of the research team will meet with potential participants in person (during their haemodialysis session) to provide the initial details of the study and participant information sheet (PIS). Participants will then be given at least 48 hours to consider whether they wish to participate before being re-contacted by a member of the research team (i.e., during the participant’s next haemodialysis session). If participants wish to take part in the study, a member of the research team will discuss the PIS further if needed and give participants the opportunity to ask questions. Once participants have agreed to take part in the study, the usual care group will take daily one bottle (125 ml) of Fortisip Compact Protein® (standard food supplement) for 24 weeks, and the intervention group will take daily one sachet (74 g) dissolved in 125 ml of water of an immuno-nutrition supplement (Oral Impact®, Nestle) for 24 weeks. Participants in both groups will continue to receive individualised dietetic advice delivered by the NHS renal dietitians who are members of the participants’ usual clinical care team. Consumption of both food supplements will be supervised during haemodialysis sessions (thrice weekly) and self-reported (written and counting returned sachets/bottles) on non-dialysis days to assess adherence. Participants will receive precise instructions on how and when to take the supplements with close monitoring by the research team to encourage adherence. Before par
1. Aged >=18 years (no upper age limit) 2. Dialysis regime of >=3 haemodialysis sessions/week for >=3 hours using biocompatible dialysers 3. Able to give informed consent
1. Treatment with immunosuppressant drugs 2. Body mass index (BMI) >35 kg/m² 3. Pregnancy, breastfeeding or intending pregnancy 4. Expected survival <6 months (prognosis assessed and determined by an experienced consultant nephrologist) 5. Hospitalisation at time of screening 6. Known intolerance/allergy to either supplement (or isolated ingredients) 7. Pre-dialysis serum potassium >5.3 mmol/l