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Completed

NCT Number: NCT05700851

Immuno-nutrition Supplementation in Haemodialysis

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.

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Key information

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Renal Medicine, Royal Derby Hospital

Derby, Derbyshire, DE22 3NE, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Immuno-nutrition supplement

Dietary 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: Oral Impact®, Nestlé

Primary outcomes

  1. C Reactive Protein - Marker of Systemic Inflammation

    Time frame: 6 weeks

    C reactive protein levels in mg/L using a high-sensitive laboratory test

  2. Interleukin-6 - Marker of Systemic Inflammation

    Time frame: 6 weeks

    Interleukin-6 levels in pg/ml using enzyme-linked immunosorbent assay

  3. Interleukin-8 - Marker of Systemic Inflammation

    Time frame: 6 weeks

    Interleukin-8 levels in pg/ml using enzyme-linked immunosorbent assay

Secondary outcomes

  1. Skeletal Muscle Mass

    Time frame: 6 weeks

    Skeletal muscle mass in kg assessed with the InBody 770 Multi-Frequency Bioimpedance Analysis equipment.

  2. Energy Intake

    Time frame: 6 weeks

    Energy intake in kcal/kg of body weight/day assessed with 3-day food diaries and analysed using the diet software Nutritics

  3. Protein Intake

    Time frame: 6 weeks

    Protein intake in g/kg of body weight/day assessed with 3-day food diaries and analysed using the diet software Nutritics

  4. Handgrip Strength - a Measure of Muscle Strength

    Time frame: 6 weeks

    Handgrip strength in kg measured with the Takei 5401 handgrip digital dynamometer

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Collaborators

  • University Hospitals of Derby and Burton NHS Foundation Trust

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 26, 2023
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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