A High Protein Egg White Pudding for People With Kidney Failure (HiPE KF)

Seven Oaks Hospital Chronic Disease Innovation Centre

Status: Not yet enrolling

Conditions: Kidney Failure; Frailty; Kidney Disease, Chronic

Treatments: Dietary Supplement: : Ensure Plus; Dietary Supplement: Egg white protein pudding

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT06343727

HS25870 (H2023:026)

Details and patient eligibility

About

The goal of this clinical trial is to compare protein supplements in patients with kidney failure on dialysis. The main questions it aims to answer are:

• To determine whether the supplementation of egg white protein pudding in a population of individuals with kidney failure on dialysis is feasible.
• To determine whether egg white protein pudding supplementation improves serum albumin similar to other standard nutritional supplements.
• To determine the effects of the egg white protein pudding on frailty measures, dietary intakes and analytes in the blood and urine. Participants will receive either the egg white pudding (experimental) or control (Ensure plus) at the end of their dialysis treatments 3-days per week for 12 weeks.

Enrollment: 54 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant is willing and able to give informed consent for participation in the trial
• Male or female aged ≥18 years with CKD
• On chronic in-center hemodialysis for > 3 months
• Serum albumin <35 g/L
• No expected change in dialysis modality or relocation outside of Winnipeg during the intervention period (12 weeks)

Exclusion criteria

• Allergy to eggs
• History of renal transplant
• Serum albumin ≥ 35 g/L
• Bowel diseases
• Cancer
• Pregnancy
• Receiving chemotherapy treatment
• Inability to consume treatment product
• Allergy to study treatment ingredients
• Planning on starting an exercise program during the duration of the trial
• Inability to obtain written informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 2 patient groups

Egg white protein pudding

Experimental group

Description:

Participants will receive egg white pudding at the end of their dialysis treatments 3-days per week.

Treatment:

Dietary Supplement: Egg white protein pudding

Dietary Supplement: : Ensure Plus

: Standard dietary supplement

Active Comparator group

Description:

Participants will receive Ensure Plus at the end of their dialysis treatments 3-days per week.

Treatment:

Dietary Supplement: Egg white protein pudding

Dietary Supplement: : Ensure Plus