Clinical trial NCT06343727: A High Protein Egg White Pudding for People With Kidney Failure (HiPE KF)
Official title: A High Protein Egg White Pudding for People With Kidney Failure (HiPE KF)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Kidney Failure
Frailty
Kidney Disease, Chronic
Lead sponsor: Seven Oaks Hospital Chronic Disease Innovation Centre
Sponsor class: NETWORK
Collaborators: name: University of Manitoba
name: Manitoba Egg Farmers
First posted: 2024-04-03
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This trial is an open-label randomized controlled parallel arm feasibility tria
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Eligibility to randomization ratio
timeFrame: Measured at the end of 12 weeks.
measure: Weekly recruitment rate
timeFrame: 12 months
measure: Adherence to Egg pudding
timeFrame: Measured at the end of12 weeks
Secondary outcomes:
measure: Serum albumin
timeFrame: Measured at the end of 12 weeks.
measure: Hand grip strength
timeFrame: Measured at the end of 12 weeks.
measure: Change in gait speed
timeFrame: Measured at the end of 12 weeks.
measure: Five rep chair stand time
timeFrame: Measured at the end of 12 weeks.
measure: Tandem balance time
timeFrame: Measured at the end of 12 weeks.
measure: Serum bicarbonate
timeFrame: Measured at the end of 12 weeks.
measure: Calcium
timeFrame: Measured at the end of 12 weeks.
measure: Urine albumin
timeFrame: Measured at the end of 12 weeks.
measure: chloride
timeFrame: Measured at the end of 12 weeks.
measure: phosphorus
timeFrame: Measured at the end of 12 weeks.
measure: Potassium
timeFrame: Measured at the end of 12 weeks.
measure: Sodium
timeFrame: Measured at the end of 12 weeks.
measure: HbA1c
timeFrame: Measured at the end of 12 weeks.
Other outcomes:
Locations:
Study officials:
References: