Immuno-nutrition Supplementation in Haemodialysis

NCT05700851 | Completed Results

• 2 other identifiers: 21085309937
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis

Keywords

Haemodialysis; Systemic inflammation; Skeletal muscle mass; Immuno-nutrition

Outcome Measures

Primary Outcomes (3)

• C Reactive Protein - Marker of Systemic Inflammation

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

  6 weeks

• Interleukin-6 - Marker of Systemic Inflammation

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

  6 weeks

• Interleukin-8 - Marker of Systemic Inflammation

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

  6 weeks

Secondary Outcomes (4)

• Skeletal Muscle Mass

  6 weeks

• Energy Intake

  6 weeks

• Protein Intake

  6 weeks

• Handgrip Strength - a Measure of Muscle Strength

  6 weeks

Study Arms (1)

Immuno-nutrition

OTHER

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

Interventions

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.

Also known as: Oral Impact®, Nestlé

Immuno-nutrition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nottingham: lead
• University Hospitals of Derby and Burton NHS Foundation Trust: collaborator

Study Sites (1)

Department of Renal Medicine, Royal Derby Hospital

Derby, Derbyshire, DE22 3NE, United Kingdom

Location

Results Point of Contact

• Title: Prof. Maarten Taal
• Organization: University of Nottingham

m.taal@nottingham.ac.uk

01332224618

Study Officials

• Maarten Taal

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2022
• First Posted: January 26, 2023
• Study Start: September 27, 2022
• Primary Completion: December 9, 2022
• Study Completion: December 9, 2022
• Last Updated: December 6, 2024
• Results First Posted: December 6, 2024

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)