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

Frailty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06343727
• Other study ID #: HS25870 (H2023:026)
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: July 1, 2025

Study information

• Verified date: March 2024
• Source: Seven Oaks Hospital Chronic Disease Innovation Centre
• Contact: Navdeep Tangri, MD, PhD
• Phone: 2046313834
• Email: ntangri[@]sogh.mb.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 54
• Est. completion date: July 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty
• Kidney Disease, Chronic
• Kidney Diseases
• Kidney Failure
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Seven Oaks Hospital Chronic Disease Innovation Centre	Manitoba Egg Farmers, University of Manitoba

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Weekly recruitment rate	Number of new participants per weeks of active recruitment	12 months
Primary	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	Serum albumin	Serum albumin is measured in grams per deciliter (g/dL)	Measured at the end of 12 weeks.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Tandem balance time	Measured in Seconds	Measured at the end of 12 weeks.
Secondary	Serum bicarbonate	Serum bicarbonate concentration in milliequivalents per liter (mEq/L)	Measured at the end of 12 weeks.
Secondary	Calcium	Total blood calcium concentration in mmol/L	Measured at the end of 12 weeks.
Secondary	Urine albumin	Total urine albumin concentration in µg/min	Measured at the end of 12 weeks.
Secondary	chloride	Total blood chloride concentration in mmol/L	Measured at the end of 12 weeks.
Secondary	phosphorus	The total blood phosphorus concentration in mmol/L	Measured at the end of 12 weeks.
Secondary	Potassium	The total blood potassium concentration in mmol/L	Measured at the end of 12 weeks.
Secondary	Sodium	The total sodium concentration in mmol/L	Measured at the end of 12 weeks.
Secondary	HbA1c	Total blood glucose concentration in mmol/L	Measured at the end of 12 weeks.