Immuno-nutrition Supplementation in Haemodialysis

University of Nottingham

Status: Completed

Conditions: Chronic Kidney Disease Requiring Chronic Dialysis

Treatments: Dietary Supplement: Immuno-nutrition supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT05700851

21085

309937 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Immuno-nutrition

Other group

Description:

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.

Treatment:

Dietary Supplement: Immuno-nutrition supplement