Protein Supplementation During Dialysis (PROSED)

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

Interventions

DIETARY_SUPPLEMENT

High Protein Diet/Modular protein supplements will be used

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

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust

  collaborator OTHER

• University Hospitals of Derby and Burton NHS Foundation Trust

  collaborator OTHER

• University of Nottingham

  lead OTHER

Principal Investigators

• Nicholas Selby, BMedSci BMBS DM · University of Nottingham

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-05

Primary Completion

2028-10-30

Completion

2029-10-30

Countries

• United Kingdom

Study Locations