Effect of Immuno-nutrition on Systemic Inflammation in People Receiving Haemodialysis: a Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Kidney Disease Requiring Chronic Dialysis
- Sponsor
- University of Nottingham
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- C Reactive Protein - Marker of Systemic Inflammation
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
C Reactive Protein - Marker of Systemic Inflammation
Time Frame: 6 weeks
C reactive protein levels in mg/L using a high-sensitive laboratory test
Interleukin-6 - Marker of Systemic Inflammation
Time Frame: 6 weeks
Interleukin-6 levels in pg/ml using enzyme-linked immunosorbent assay
Interleukin-8 - Marker of Systemic Inflammation
Time Frame: 6 weeks
Interleukin-8 levels in pg/ml using enzyme-linked immunosorbent assay
Secondary Outcomes
- Skeletal Muscle Mass(6 weeks)
- Energy Intake(6 weeks)
- Protein Intake(6 weeks)
- Handgrip Strength - a Measure of Muscle Strength(6 weeks)