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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Frailty; Kidney Disease, Chronic; Kidney Failure
• Intervention / Treatment: Dietary supplement: Egg white protein pudding; Dietary supplement: : Ensure Plus

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Navdeep Tangri, MD, PhD; Phone Number: 2046313834; Email: ntangri@sogh.mb.ca
• Study Contact Backup: Name: Dianna Dandeneau, MSc; Phone Number: 2046313834; Email: ddandeneau@sogh.mb.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Egg white protein pudding; Participants will receive egg white pudding at the end of their dialysis treatments 3-days per week.	Dietary supplement: Egg white protein pudding; Will consume one egg white protein pudding at the end of their dialysis treatments 3-days per week for 12 weeks; Dietary supplement: : Ensure Plus; Will consume one Ensure Plus at the end of their dialysis treatments 3-days per week for 12 weeks
Active Comparator: : Standard dietary supplement; Participants will receive Ensure Plus at the end of their dialysis treatments 3-days per week.	Dietary supplement: Egg white protein pudding; Will consume one egg white protein pudding at the end of their dialysis treatments 3-days per week for 12 weeks; Dietary supplement: : Ensure Plus; Will consume one Ensure Plus at the end of their dialysis treatments 3-days per week for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weekly recruitment rate	Number of new participants per weeks of active recruitment	12 months
Eligibility to randomization ratio	A ratio of eligibility to randomization expressed as percentage will be collected at 12 months to investigate egg pudding intervention feasibility.	Measured at the end of 12 weeks.
Adherence to Egg pudding	Adherence to egg white product intervention calculated by consumption of >75% dispensed egg white protein products.	Measured at the end of12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seven Oaks Hospital Chronic Disease Innovation Centre
• Collaborators: University of Manitoba; Manitoba Egg Farmers

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: February 7, 2024
• First Submitted That Met QC Criteria: March 26, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Frailty
• Other Study ID Numbers: HS25870 (H2023:026)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No