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

NCT06343727 | Recruiting

• 1 other identifier: HS25870 (H2023:026)
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

Brief Summary

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. 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.

Conditions

Kidney Failure; Frailty; Kidney Disease, Chronic

Outcome Measures

Primary Outcomes (4)

• Eligibility to randomization ratio

  A ratio of eligibility to randomization will be collected at 12 months using pre-specified red-yellow-green progression criteria to investigate egg pudding intervention feasibility. The trial will be considered feasible if ratio falls within green zone (\>0.5). The outcome in the yellow zone (0.2-0.5) indicate that modifications to trial design may be necessary and in the red zone (\<0.2) will suggest the trial is not feasible.

  Measured at the end of 12 weeks.

• Recruitment rate

  Recruitment rate will be assessed as the number of new participants enrolled per site per month during active recruitment using the red-yellow-green progression criteria. Green: ≥ 0.75 participants/site/month - Feasible; Yellow: 0.25 - \<0.75 participants/site/month - Modification may be necessary; Red: \< 0.25 participants /site/month - Not feasible

  12 months

• Follow up rate

  Follow-up rate (% of participant outcomes) will be calculated using the red-yellow-green progression criteria. Green: \> 90% - Feasible; Yellow: (75% - 90%) -Modifications may be necessary; Red: \<75% -Not feasible.

  Measured at the end of 12 weeks.

• Adherence to Intervention

  Adherence to egg white product intervention (% of dispensed egg white protein consumed) will be calculated using red-yellow-green progression criteria. Green: \> 75% - Feasible; Yellow: 50%-75% - Modifications may be necessary; Red: \<50% - Not feasible

  Measured at the end of12 weeks

Secondary Outcomes (15)

• Hand grip strength

  Measured at the end of 12 weeks.

• Change in gait speed

  Measured at the end of 12 weeks.

• Five rep chair stand time

  Measured at the end of 12 weeks.

• Tandem balance time

  Measured at the end of 12 weeks.

• Serum albumin

  Measured at the end of 12 weeks.

Study Arms (2)

Egg white protein pudding

EXPERIMENTAL

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

Dietary Supplement: Egg white protein pudding

: Standard dietary supplement

ACTIVE COMPARATOR

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

Dietary Supplement: : Ensure Plus

Interventions

Egg white protein pudding DIETARY_SUPPLEMENT

Will consume one egg white protein pudding at the end of their dialysis treatments 3-days per week for 12 weeks

Egg white protein pudding

: Ensure Plus DIETARY_SUPPLEMENT

Will consume one Ensure Plus at the end of their dialysis treatments 3-days per week for 12 weeks

: Standard dietary supplement

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Seven Oaks Hospital Chronic Disease Innovation Centre: lead
• University of Manitoba: collaborator
• Manitoba Egg Farmers: collaborator

Study Sites (2)

Seven Oaks General Hospital

Winnipeg, Manitoba, R2V 3M3, Canada

RECRUITING

Health Science Centre

Winnipeg, Manitoba, R3A 1R9, Canada

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency; Frailty; Renal Insufficiency, Chronic

Interventions

Ensure Plus

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Chronic Disease; Disease Attributes

Central Study Contacts

Navdeep Tangri, MD, PhD

CONTACT

2046313834; ntangri@sogh.mb.ca

Tahmina Rahman, MSc

CONTACT

2046313834; trahman2@sogh.mb.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: This trial is an open-label randomized controlled parallel arm feasibility trial

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: April 3, 2024
• Study Start: July 25, 2025
• Primary Completion (Estimated): August 11, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)