Immuno-nutrition Supplementation in Haemodialysis
- Conditions
- Chronic Kidney Disease Requiring Chronic Dialysis
- Registration Number
- NCT05700851
- Lead Sponsor
- University of Nottingham
- 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
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- 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
Trial Locations
- Locations (1)
Department of Renal Medicine, Royal Derby Hospital
🇬🇧Derby, Derbyshire, United Kingdom
Department of Renal Medicine, Royal Derby Hospital🇬🇧Derby, Derbyshire, United Kingdom