A High Protein Egg White Pudding for People With Kidney Failure (HiPE KF)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Egg white protein pudding, : Ensure Plus.
- Who it may be relevant to
- Registry conditions: Kidney Failure, Frailty, Kidney Disease, Chronic. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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 - Dietary supplement : Ensure Plus
Will consume one Ensure Plus at the end of their dialysis treatments 3-days per week for 12 weeks
Primary outcome measures
- Eligibility to randomization ratio [Time frame: Measured at the end of 12 weeks.]
- Recruitment rate [Time frame: 12 months]
- Follow up rate [Time frame: Measured at the end of 12 weeks.]
- Adherence to Intervention [Time frame: Measured at the end of12 weeks]
Secondary outcome measures (12)
- Hand grip strength [Time frame: Measured at the end of 12 weeks.]
- Change in gait speed [Time frame: Measured at the end of 12 weeks.]
- Five rep chair stand time [Time frame: Measured at the end of 12 weeks.]
- Tandem balance time [Time frame: Measured at the end of 12 weeks.]
- Serum albumin [Time frame: Measured at the end of 12 weeks.]
- Serum bicarbonate [Time frame: Measured at the end of 12 weeks.]
- Calcium [Time frame: Measured at the end of 12 weeks.]
- chloride [Time frame: Measured at the end of 12 weeks.]
- phosphorus [Time frame: Measured at the end of 12 weeks.]
- Potassium [Time frame: Measured at the end of 12 weeks.]
- Sodium [Time frame: Measured at the end of 12 weeks.]
- HbA1c [Time frame: Measured at the end of 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Canada · 2 centers
- Seven Oaks General Hospital — Winnipeg
- Health Science Centre — Winnipeg
Identifiers
NCT: NCT06343727 · HS25870 (H2023:026)