High-protein egg white pudding for people on dialysis
A High Protein Egg White Pudding for People With Kidney Failure (HiPE KF)
This trial will try whether giving an egg white protein pudding to adults on in-center hemodialysis with low albumin helps their nutrition compared with a standard supplement (Ensure Plus).
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Seven Oaks Hospital Chronic Disease Innovation Centre Research network |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Winnipeg, Manitoba and 1 other locations) |
| Trial ID | NCT06343727 on ClinicalTrials.gov |
What this trial studies
This interventional study compares an egg white protein pudding to a standard oral nutritional supplement (Ensure Plus) in adults on chronic in-center hemodialysis who have low serum albumin. Participants receive the assigned supplement at the end of their dialysis sessions three times per week for 12 weeks. The trial will test feasibility of delivering the pudding and whether it raises serum albumin similarly to Ensure Plus, with secondary measures including frailty tests, dietary intake, and blood analytes. The study is run at two Winnipeg hospitals and enrolls adults who can consent, have been on dialysis for over three months, and have serum albumin under 35 g/L.
Who should consider this trial
Good fit: Adults (≥18) on chronic in-center hemodialysis for more than three months with serum albumin below 35 g/L who can consume the product and give informed consent.
Not a fit: People with egg allergy, recent transplant history, active cancer, pregnancy, current chemotherapy, inability to eat the product, or normal serum albumin (≥35 g/L) are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the pudding could provide an affordable, egg-based protein option that improves serum albumin and physical frailty in dialysis patients.
How similar studies have performed: Oral protein supplements such as Ensure have shown modest benefits in dialysis populations in prior studies, but the specific egg white pudding formulation is a novel approach without large prior trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Winnipeg, Manitoba and 1 other locations
- Seven Oaks General Hospital — Winnipeg, Manitoba, Canada (Recruiting)
- Health Science Centre — Winnipeg, Manitoba, Canada (Recruiting)
Study contacts
- Study coordinator: Navdeep Tangri, MD, PhD
- Email: ntangri@sogh.mb.ca
- Phone: 2046313834
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.