Immuno-nutrition Supplementation in Haemodialysis

Effect of Immuno-nutrition on Systemic Inflammation in People Receiving Haemodialysis: a Pilot Study

The purpose of this pilot study is to test if an "immuno-nutrition" supplement can decrease inflammation in people on haemodialysis. This immuno-nutrition supplement is high in calories and protein like other common nutritional supplements, but also contains a unique combination of ingredients that have been shown to reduce inflammation (a problem which is caused by the body's defence [immune] system communicating that something is wrong) and improve the immune system in people with cancer. The research team hopes that this small study will help with gaining a good understanding of the effect of immuno-nutrition on inflammation in people on haemodialysis, which will guide and allow the research team to do a larger research study in the future.

Participants will be asked to take one sachet of the immuno-nutrition supplement each day for 6 weeks. The renal dietitian on the research team will provide participants with detailed oral advice on how and when to take the immuno-nutrition supplement.

Participants will need to complete 3-day food diaries at the beginning, mid-way point and end of the study.

The research team will measure weight, height, handgrip strength (a measure of muscle strength), body's composition of fat and muscle using a specialist scale, and skin autofluorescence levels (a measure of toxins called advanced glycation end-products).

The research team will collect the results of routine blood tests. The research team will also collect and store blood samples taken before and after a haemodialysis session to measure some molecules that indicate inflammation.

All of these measurements and samples will be taken at the start of the study, and after 6 weeks of taking the immuno-nutrition supplement.

Inclusion Criteria:

• CRP level >5.0 mg/L.
• At least three haemodialysis sessions per week for ≥3 hours using a biocompatible dialyser.
• Able to give informed consent.

Exclusion Criteria:

• Treatment with drugs that cause immunosuppression.
• Non-English speakers or those with special communication needs.
• Pregnancy, breast feeding or intending pregnancy.
• Expected survival <6 months.
• Hospitalisation at the time of screening.
• Known intolerance or allergy to ONS (or isolated ingredients).
• Pre-dialysis serum potassium >5.0 mmol/L.
• Unable to provide informed consent.