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NCT Number: NCT06343727

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. 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.

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Key information

Conditions

Kidney Failure Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Frailty Kidney Disease, Chronic Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Science Centre, Winnipeg, Manitoba, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

: Ensure Plus

Dietary Supplement

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

Primary outcomes

  1. Eligibility to randomization ratio

    Time frame: 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.

  2. Recruitment rate

    Time frame: 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

  3. Follow up rate

    Time frame: 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.

  4. Adherence to Intervention

    Time frame: 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 outcomes

  1. Hand grip strength

    Time frame: 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.

  2. Change in gait speed

    Time frame: Measured at the end of 12 weeks.

    Gait speed is measured by the predetermined distance/time to walk that distance (e.g., 5m/__sec)

  3. Five rep chair stand time

    Time frame: 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

  4. Tandem balance time

    Time frame: Measured at the end of 12 weeks.

    Measured in Seconds

  5. Serum albumin

    Time frame: Measured at the end of 12 weeks.

    Serum albumin is measured in grams per deciliter (g/dL)

  6. Serum bicarbonate

    Time frame: Measured at the end of 12 weeks.

    Serum bicarbonate concentration in milliequivalents per liter (mEq/L)

  7. Calcium

    Time frame: Measured at the end of 12 weeks.

    Total blood calcium concentration in mmol/L

  8. chloride

    Time frame: Measured at the end of 12 weeks.

    Total blood chloride concentration in mmol/L

  9. phosphorus

    Time frame: Measured at the end of 12 weeks.

    The total blood phosphorus concentration in mmol/L

  10. Potassium

    Time frame: Measured at the end of 12 weeks.

    The total blood potassium concentration in mmol/L

  11. Sodium

    Time frame: Measured at the end of 12 weeks.

    The total sodium concentration in mmol/L

  12. HbA1c

    Time frame: Measured at the end of 12 weeks.

    Total blood glucose concentration in mmol/L

  13. Dry Weight

    Time frame: Measured at the end of 12 weeks

    Measured in kg

  14. Height

    Time frame: Measured at the end of 12 weeks

    Measured in cm

  15. Pre-dialysis Blood pressure

    Time frame: Measured at the end of 12 weeks

    Systolic and diastolic blood pressure measured in mmHg

Study contacts

Contact information is provided by the study sponsor or research team.

Navdeep Tangri, MD, PhD

CONTACT

[email protected]

2046313834

Tahmina Rahman, MSc

CONTACT

[email protected]

2046313834

Sponsors and collaborators

Lead sponsor

Seven Oaks Hospital Chronic Disease Innovation Centre

Network

Collaborators

  • Manitoba Egg Farmers
  • University of Manitoba

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 3, 2024
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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