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

NCT ID: NCT06343727

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-25

Study Completion Date

2026-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Failure Frailty Kidney Disease, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This trial is an open-label randomized controlled parallel arm feasibility trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Egg white protein pudding

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

Group Type EXPERIMENTAL

Egg white protein pudding

Intervention Type DIETARY_SUPPLEMENT

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

: Standard dietary supplement

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

Group Type ACTIVE_COMPARATOR

: Ensure Plus

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

: Ensure Plus

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Manitoba

OTHER

Sponsor Role collaborator

Manitoba Egg Farmers

UNKNOWN

Sponsor Role collaborator

Seven Oaks Hospital Chronic Disease Innovation Centre

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seven Oaks General Hospital

Winnipeg, Manitoba, Canada

Site Status RECRUITING

Health Science Centre

Winnipeg, Manitoba, Canada

Site Status NOT_YET_RECRUITING

Countries

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Canada

Central Contacts

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Navdeep Tangri, MD, PhD

Role: CONTACT

2046313834

Tahmina Rahman, MSc

Role: CONTACT

2046313834

Facility Contacts

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Navdeep Tangri, PhD, MD

Role: primary

204 631-3834

Rebecca Mollard, PhD

Role: backup

204 631-3834

Navdeep Tangri, PhD

Role: primary

204-631-3834

Rebecca Mollard, PhD

Role: backup

204-631-3834

Other Identifiers

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HS25870 (H2023:026)

Identifier Type: -

Identifier Source: org_study_id

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