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

Not Applicable

Not yet recruiting

• Conditions: Frailty; Kidney Disease, Chronic; Kidney Failure

• Registration Number: NCT06343727
• Lead Sponsor: Seven Oaks Hospital Chronic Disease Innovation Centre

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-07
• Study First Submitted QC: 2024-03-26
• Study First Posted: 2024-04-03
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-08
• Last Update Posted: 2025-07-11
• Study Start: 2025-07-15
• Primary Completion: 2026-06-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Eligibility to randomization ratio	Measured at the end of 12 weeks.	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.
Recruitment rate	12 months	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
Follow up rate	Measured at the end of 12 weeks.	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.
Adherence to Intervention	Measured at the end of12 weeks	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

Secondary Outcome Measures

Name	Time	Method
Hand grip strength	Measured at the end of 12 weeks.	Measuring the amount of static force that the hand can squeeze around a dynamometer. Measured in kilograms and pounds.
Serum bicarbonate	Measured at the end of 12 weeks.	Serum bicarbonate concentration in milliequivalents per liter (mEq/L)
Calcium	Measured at the end of 12 weeks.	Total blood calcium concentration in mmol/L
Serum albumin	Measured at the end of 12 weeks.	Serum albumin is measured in grams per deciliter (g/dL)
Five rep chair stand time	Measured at the end of 12 weeks.	the amount of time it takes for a participant to get up out of a chair five times measured in seconds
Urine albumin	Measured at the end of 12 weeks.	Total urine albumin concentration in µg/min
Change in gait speed	Measured at the end of 12 weeks.	Gait speed is measured by the predetermined distance/time to walk that distance (e.g., 5m/__sec)
Tandem balance time	Measured at the end of 12 weeks.	Measured in Seconds
Potassium	Measured at the end of 12 weeks.	The total blood potassium concentration in mmol/L
HbA1c	Measured at the end of 12 weeks.	Total blood glucose concentration in mmol/L
Sodium	Measured at the end of 12 weeks.	The total sodium concentration in mmol/L
phosphorus	Measured at the end of 12 weeks.	The total blood phosphorus concentration in mmol/L
chloride	Measured at the end of 12 weeks.	Total blood chloride concentration in mmol/L

Trial Locations

Locations (2)

Seven Oaks General Hospital; 🇨🇦 Winnipeg, Manitoba, Canada

Health Science Centre; 🇨🇦 Winnipeg, Manitoba, Canada