Immuno-nutrition Supplementation in Haemodialysis
Effect of Immuno-nutrition on Systemic Inflammation in People Receiving Haemodialysis: a Pilot Study
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Derbyshire
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Derby, Derbyshire, United Kingdom, DE22 3NE
- Department of Renal Medicine, Royal Derby Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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. |
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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
C Reactive Protein - Marker of Systemic Inflammation
Time Frame: 6 weeks
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C reactive protein levels in mg/L using a high-sensitive laboratory test
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6 weeks
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Interleukin-6 - Marker of Systemic Inflammation
Time Frame: 6 weeks
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Interleukin-6 levels in pg/ml using enzyme-linked immunosorbent assay
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6 weeks
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Interleukin-8 - Marker of Systemic Inflammation
Time Frame: 6 weeks
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Interleukin-8 levels in pg/ml using enzyme-linked immunosorbent assay
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6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Skeletal Muscle Mass
Time Frame: 6 weeks
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Skeletal muscle mass in kg assessed with the InBody 770 Multi-Frequency Bioimpedance Analysis equipment.
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6 weeks
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Energy Intake
Time Frame: 6 weeks
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Energy intake in kcal/kg of body weight/day assessed with 3-day food diaries and analysed using the diet software Nutritics
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6 weeks
|
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Protein Intake
Time Frame: 6 weeks
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Protein intake in g/kg of body weight/day assessed with 3-day food diaries and analysed using the diet software Nutritics
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6 weeks
|
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Handgrip Strength - a Measure of Muscle Strength
Time Frame: 6 weeks
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Handgrip strength in kg measured with the Takei 5401 handgrip digital dynamometer
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6 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maarten Taal, University of Nottingham
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21085
- 309937 (Other Identifier: IRAS ID)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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