Immuno-nutrition Supplementation in Haemodialysis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Immuno-nutrition on Systemic Inflammation in People Receiving Haemodialysis: a Pilot Study

Conditions
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Chronic Kidney Disease Requiring Chronic Dialysis

Intervention / Treatment
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* Dietary Supplement: Immuno-nutrition supplement


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Immuno-nutrition<br>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. | Dietary Supplement: Immuno-nutrition supplement<br>* Oral Impact® is a powdered oral nutritional supplement that contains a unique combination of ingredients with immuno-modulating properties, namely omega-3 fatty acids, arginine and nucleotides, as well as soluble fibre.<br>* Other names: Oral Impact®, Nestlé;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic inflammation | Change in C reactive protein in mg/L using a high-sensitive laboratory test | 0 and 6 weeks | 
| Systemic inflammation | Change in interleukin-6, interleukin-8, interleukin-10 and tumor necrosis factor-alpha in pg/ml using enzyme-linked immunosorbent assays (ELISA) | 0 and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemoglobin and protein status | Change in haemoglobin, serum albumin and total protein in g/L using standard biochemistry and haematology testing | 0 and 6 weeks | 
| Creatinine | Change in serum creatinine in micromoles/L using standard biochemistry testing | 0 and 6 weeks | 
| Urea, electrolytes, minerals and lipid profile. | Change in serum urea, potassium, phosphate, calcium, sodium, total cholesterol and triglycerides in mmol/L using standard biochemistry testing | 0 and 6 weeks | 
| Body mass index | Change in body mass index in kg/m2 using weight and height for calculation | 0 and 6 weeks | 
| Body lean mass | Change in skeletal muscle mass, fat-free mass and soft lean mass in kg assessed with the InBody 770 Multi-Frequency Bioimpedance Analysis machine | 0 and 6 weeks | 
| Body fat mass | Change in body fat mass in kg and % assessed with the InBody 770 Multi-Frequency Bioimpedance Analysis machine | 0 and 6 weeks | 
| Energy intake | Change in energy intake in kcal/day assessed with 3-day food diaries and analysed using the diet software Nutritics | 0 and 6 weeks | 
| Protein and fat intake | Change in protein and fat intake in g/day with 3-day food diaries and analysed using the diet software Nutritics | 0 and 6 weeks | 
| Muscle strength | Change in muscle strength in kg assessed with handgrip strength | 0 and 6 weeks | 
| Skin autofluorescence | Change in skin autofluorescence levels in arbitrary units assessed with a validated Autofluorescence Reader | 0 and 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Haemodialysis, Systemic inflammation, Skeletal muscle mass, Immuno-nutrition