Clinical trial NCT05700851: Immuno-nutrition Supplementation in Haemodialysis
Official title: Effect of Immuno-nutrition on Systemic Inflammation in People Receiving Haemodialysis: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
Keywords: Haemodialysis
Systemic inflammation
Skeletal muscle mass
Immuno-nutrition
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: University Hospitals of Derby and Burton NHS Foundation Trust
First posted: 2023-01-26
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: C Reactive Protein - Marker of Systemic Inflammation
timeFrame: 6 weeks
measure: Interleukin-6 - Marker of Systemic Inflammation
timeFrame: 6 weeks
measure: Interleukin-8 - Marker of Systemic Inflammation
timeFrame: 6 weeks
Secondary outcomes:
measure: Skeletal Muscle Mass
timeFrame: 6 weeks
measure: Energy Intake
timeFrame: 6 weeks
measure: Protein Intake
timeFrame: 6 weeks
measure: Handgrip Strength - a Measure of Muscle Strength
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Derby
country: United Kingdom
facility: Department of Renal Medicine, Royal Derby Hospital
state: Derbyshire
Study officials:
affiliation: University of Nottingham
name: Maarten Taal
role: PRINCIPAL_INVESTIGATOR
References: