Immuno-nutrition Supplementation in Haemodialysis

Not Applicable

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Immuno-nutrition	Immuno-nutrition supplement	Participants will be advised to take daily one sachet (74 g) of the immuno-nutrition supplement (Oral Impact®, Nestle) dissolved in 125 ml of water and will be followed-up for 6 weeks. Participants will receive individualised (to patient needs and food preferences) dietetic advice formulated and delivered by an experienced renal dietitian under an honorary NHS research contract, who is a member of the research team and will be supervised by an NHS renal dietitian, aiming to achieve estimated nutritional requirements for people on haemodialysis (i.e., energy: 30-35 kcal/kg/day, and protein intake: 1.0-1.2 g/kg/day). Each dietetic advice provided to participants will also be reviewed by the NHS clinical renal dietitians who are members of the participants' usual clinical care team.

Primary Outcome Measures

Name	Time	Method
C Reactive Protein - Marker of Systemic Inflammation	6 weeks	C reactive protein levels in mg/L using a high-sensitive laboratory test
Interleukin-6 - Marker of Systemic Inflammation	6 weeks	Interleukin-6 levels in pg/ml using enzyme-linked immunosorbent assay
Interleukin-8 - Marker of Systemic Inflammation	6 weeks	Interleukin-8 levels in pg/ml using enzyme-linked immunosorbent assay

Secondary Outcome Measures

Name	Time	Method
Skeletal Muscle Mass	6 weeks	Skeletal muscle mass in kg assessed with the InBody 770 Multi-Frequency Bioimpedance Analysis equipment.
Energy Intake	6 weeks	Energy intake in kcal/kg of body weight/day assessed with 3-day food diaries and analysed using the diet software Nutritics
Protein Intake	6 weeks	Protein intake in g/kg of body weight/day assessed with 3-day food diaries and analysed using the diet software Nutritics
Handgrip Strength - a Measure of Muscle Strength	6 weeks	Handgrip strength in kg measured with the Takei 5401 handgrip digital dynamometer