Immuno-nutrition Supplementation in Haemodialysis

Chronic Kidney Disease Requiring Chronic Dialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05700851
• Other study ID #: 21085
• Secondary ID: 309937
• Status: Completed
• Phase: N/A
• Start date: September 27, 2022
• Est. completion date: December 9, 2022

Study information

• Verified date: January 2023
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 9, 2022
• Est. primary completion date: December 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease Requiring Chronic Dialysis
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Department of Renal Medicine, Royal Derby Hospital	Derby	Derbyshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Nottingham	University Hospitals of Derby and Burton NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systemic inflammation	Change in C reactive protein in mg/L using a high-sensitive laboratory test	0 and 6 weeks
Primary	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	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
Secondary	Creatinine	Change in serum creatinine in micromoles/L using standard biochemistry testing	0 and 6 weeks
Secondary	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
Secondary	Body mass index	Change in body mass index in kg/m2 using weight and height for calculation	0 and 6 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Muscle strength	Change in muscle strength in kg assessed with handgrip strength	0 and 6 weeks
Secondary	Skin autofluorescence	Change in skin autofluorescence levels in arbitrary units assessed with a validated Autofluorescence Reader	0 and 6 weeks