Protein Supplementation During Dialysis (PROSED)

NCT07237997 | Not Yet Recruiting DMC

• 2 other identifiers: 25032SG_AHPF_001_20221129
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

When a patient has dialysis some nutrients are lost in the process. Nutritional losses include protein, trace elements (i.e. zinc, copper and selenium) and water-soluble vitamins (Vitamins C and B). These nutrients are essential for normal body function, including a good immune system and nutritional status. For example, on average the protein losses during a dialysis session (the process where the blood is cleaned via a machine and special fluid) is equal to 6g of protein/day (which is the equivalent of the amount of protein in 1 egg). Protein needs for the general population are 0.8g protein per kg of body weight. Because people on dialysis lose protein via the dialysis, it is thought that these people need to eat more protein. Currently, in clinical practice for people receiving dialysis, the guidelines are to aim for 1.1 -1.4g of protein per kg of body weight. However, the research is old and very weak. Dialysis treatments have changed over the past 40 years, and the investigator does not know if the replacement of these nutritional losses is important to how well people do on dialysis and if they have any effect on survival. Previous research is mostly limited to haemodialysis (a type of dialysis that requires a machine which cleans the patients' blood via special filters) and peritoneal dialysis (this is a type of dialysis which happens via the patients' tummy). There is no research on the nutritional supplementation in home HD and nocturnal HD. Our research will investigate if a higher protein provision leads to a reduction is hospital admissions and improved outcomes in patients receiving dialysis.

Conditions

Dialysis Patients; Dialysis; Protein Energy Wasting; Protein Intake; High Protein Dietary Intake; Diet; Diet Therapy; Hospitalisation; Muscle Mass and Strength; Muscle Mass

Outcome Measures

Primary Outcomes (1)

• To identify how protein intake and supplements influence patients' unplanned hospitalisation rate.

  Purpose To measure the impact of different amounts of protein intake (protein in the diet) on clinical outcomes (including unplanned hospital admissions) in patients receiving the different dialysis modalities (ICHD, HHD, NHD and PD). The investigators hypothesis is that a modality-specific and high-protein supplementation regimen reduces unplanned hospitalisation rate in patients receiving dialysis (ICHD, PD, HD, NHD) compared with those without supplementation.

  2 years

Secondary Outcomes (1)

• To assess association between protein intake and patients related outcomes measures.

  2 years

Study Arms (2)

Standard Protein Arm

NO INTERVENTION

In the Standard Protein Arm, participants will aim to consume at least 1.0g of protein per kg of dry body weight.

High Protein Arm

EXPERIMENTAL

In the High Protein arm, participants will need to consume 1.4g of protein per kg of dry body weight a day and protein supplements will be used to achieve this (Renapro and Renapro shot)

Dietary Supplement: High Protein Diet/Modular protein supplements will be used

Interventions

High Protein Diet/Modular protein supplements will be used DIETARY_SUPPLEMENT

High Protein Diet/Supplements 1.4g/kg/body weight/day

High Protein Arm

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years (no upper age limit)
• Patients receiving maintenance dialysis for ≥ three months
• Ability to provide informed consent

You may not qualify if:

• Anticipated live donor kidney transplant and/or kidney recovery within the period of sample collection.
• Anticipated change of dialysis modality within the period of sample collection
• Severe malnutrition based on either:
• Renal 7-point Subjective Global Assessment (SGA) scores of 1-2
• Global Leadership Initiative Malnutrition (GLIM) Stage 2
• Protein-losing enteropathy.
• Persistent nephrotic syndrome with \>3g/day urinary protein loss.
• Active wounds or burns contributing to protein losses as judged by the investigator.
• Current active acute inflammatory illness (likely to have catabolic effect in the opinion of the investigator).
• Current malignancy based on recent (\<12 months) diagnosis and/or active treatment for malignancy and/or planned treatment for malignancy, excluding non-melanoma skin cancers.
• Pregnancy (current or planned within duration of study) or breast feeding.
• People with swallowing difficulties precluding safe ingestion (International Dysphagia Diet Standardization Initiative (IDDSI) level 0 thin fluid).
• People receiving intradialytic parenteral nutrition or intra-peritoneal amino acids, or any other forms of artificial feeding
• People prescribed levodopa
• People who are receiving chronic glucocorticoid therapy (\>10mg day prednisolone or equivalent for \>7 days within preceding 90 days).

Sponsors & Collaborators

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

Study Sites (1)

Centre for Kidney Research and Innovation (CKRI), Academic Unit for Translational Medical Sciences School of Medicine (Royal Derby Hospital Campus)

Nottingham, NG7 2QL, United Kingdom

Location

Related Publications (7)

• Sahathevan S, Khor BH, Ng HM, Gafor AHA, Mat Daud ZA, Mafra D, Karupaiah T. Understanding Development of Malnutrition in Hemodialysis Patients: A Narrative Review. Nutrients. 2020 Oct 15;12(10):3147. doi: 10.3390/nu12103147.

  PMID: 33076282 BACKGROUND

• Zazzeroni L, Pasquinelli G, Nanni E, Cremonini V, Rubbi I. Comparison of Quality of Life in Patients Undergoing Hemodialysis and Peritoneal Dialysis: a Systematic Review and Meta-Analysis. Kidney Blood Press Res. 2017;42(4):717-727. doi: 10.1159/000484115. Epub 2017 Oct 19.

  PMID: 29049991 BACKGROUND

• Mafrici B, Armstrong-Brown V. Protein-energy wasting and nutritional requirements in dialysis. Journal Kidney Care 2017 2 (2), https://doi.org/10.12968/jokc.2017.2.2.

  BACKGROUND

• Hanna RM, Ghobry L, Wassef O, Rhee CM, Kalantar-Zadeh K. A Practical Approach to Nutrition, Protein-Energy Wasting, Sarcopenia, and Cachexia in Patients with Chronic Kidney Disease. Blood Purif. 2020;49(1-2):202-211. doi: 10.1159/000504240. Epub 2019 Dec 18.

  PMID: 31851983 BACKGROUND

• Viramontes-Horner D, Pittman Z, Selby NM, Taal MW. Impact of malnutrition on health-related quality of life in persons receiving dialysis: a prospective study. Br J Nutr. 2022 Jun 14;127(11):1647-1655. doi: 10.1017/S000711452100249X. Epub 2021 Jul 5.

  PMID: 34218825 BACKGROUND

• Kittiskulnam P, Chuengsaman P, Kanjanabuch T, Katesomboon S, Tungsanga S, Tiskajornsiri K, Praditpornsilpa K, Eiam-Ong S. Protein-Energy Wasting and Mortality Risk Prediction Among Peritoneal Dialysis Patients. J Ren Nutr. 2021 Nov;31(6):679-686. doi: 10.1053/j.jrn.2020.11.007. Epub 2021 Feb 25.

  PMID: 33642190 BACKGROUND

• Sabatino A, Regolisti G, Karupaiah T, Sahathevan S, Sadu Singh BK, Khor BH, Salhab N, Karavetian M, Cupisti A, Fiaccadori E. Protein-energy wasting and nutritional supplementation in patients with end-stage renal disease on hemodialysis. Clin Nutr. 2017 Jun;36(3):663-671. doi: 10.1016/j.clnu.2016.06.007. Epub 2016 Jun 18.

  PMID: 27371993 BACKGROUND

Related Links

• Lay Summary of Research Project from Kidney Research UK: What is the impact of different types of dialysis on levels of protein?

Study Officials

• Nicholas Selby, BMedSci BMBS DM

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruno Mafrici, MSc, BSc

CONTACT

0044 +115 9691169; bruno.mafrici2@nottingham.ac.uk

Matthew Hall, MA, MBBChir, MD, FRCP

CONTACT

matthew.hall10@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an interventional pilot study of protein supplementation to test the hypothesis that a higher dietary protein intake is associated with a reduced unplanned hospitalisation admission rate over 2 years. The investigators will aim to recruit 114 participants with randomisation stratified across dialysis modalities (ICHD, CAPD, APD, HHD, NHD). Recruitment proportions will align with current dialysis populations at the study units - i.e., approximately 10-15% CAPD, 10-15% APD, 5-10% HHD, 3-5% NHD and 60-70% ICHD. Description of the intervention Once consented, participants will be randomly assigned to a high-protein group or usual care. Higher and usual protein intake targets, referred as individualised protein supplementation regimen, will be set within the limits of previously published mortality data Higher protein intake will aim to achieve 1.4g protein per kg of dry body weight per day usual protein intake will aim to achieve at least 1.0g protein per kg of dry body weight

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: November 20, 2025
• Study Start: January 5, 2026
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): October 30, 2029
• Last Updated: November 20, 2025

Record last verified: 2025-07

Locations

GB (1)