Immuno-nutrition Supplementation in Haemodialysis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Immuno-nutrition 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
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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Systemic inflammation [0 and 6 weeks]
Change in C reactive protein in mg/L using a high-sensitive laboratory test
- Systemic inflammation [0 and 6 weeks]
Change in interleukin-6, interleukin-8, interleukin-10 and tumor necrosis factor-alpha in pg/ml using enzyme-linked immunosorbent assays (ELISA)
Secondary Outcome Measures
- Haemoglobin and protein status [0 and 6 weeks]
Change in haemoglobin, serum albumin and total protein in g/L using standard biochemistry and haematology testing
- Creatinine [0 and 6 weeks]
Change in serum creatinine in micromoles/L using standard biochemistry testing
- Urea, electrolytes, minerals and lipid profile. [0 and 6 weeks]
Change in serum urea, potassium, phosphate, calcium, sodium, total cholesterol and triglycerides in mmol/L using standard biochemistry testing
- Body mass index [0 and 6 weeks]
Change in body mass index in kg/m2 using weight and height for calculation
- Body lean mass [0 and 6 weeks]
Change in skeletal muscle mass, fat-free mass and soft lean mass in kg assessed with the InBody 770 Multi-Frequency Bioimpedance Analysis machine
- Body fat mass [0 and 6 weeks]
Change in body fat mass in kg and % assessed with the InBody 770 Multi-Frequency Bioimpedance Analysis machine
- Energy intake [0 and 6 weeks]
Change in energy intake in kcal/day assessed with 3-day food diaries and analysed using the diet software Nutritics
- Protein and fat intake [0 and 6 weeks]
Change in protein and fat intake in g/day with 3-day food diaries and analysed using the diet software Nutritics
- Muscle strength [0 and 6 weeks]
Change in muscle strength in kg assessed with handgrip strength
- Skin autofluorescence [0 and 6 weeks]
Change in skin autofluorescence levels in arbitrary units assessed with a validated Autofluorescence Reader
Eligibility Criteria
Criteria
Inclusion Criteria:
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CRP level >5.0 mg/L.
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At least three haemodialysis sessions per week for ≥3 hours using a biocompatible dialyser.
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Able to give informed consent.
Exclusion Criteria:
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Treatment with drugs that cause immunosuppression.
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Non-English speakers or those with special communication needs.
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Pregnancy, breast feeding or intending pregnancy.
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Expected survival <6 months.
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Hospitalisation at the time of screening.
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Known intolerance or allergy to ONS (or isolated ingredients).
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Pre-dialysis serum potassium >5.0 mmol/L.
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Unable to provide informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Renal Medicine, Royal Derby Hospital | Derby | Derbyshire | United Kingdom | DE22 3NE |
Sponsors and Collaborators
- University of Nottingham
- University Hospitals of Derby and Burton NHS Foundation Trust
Investigators
- Principal Investigator: Maarten Taal, University of Nottingham
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21085
- 309937