A High Protein Egg White Pudding for People With Kidney Failure (HiPE KF)
- Conditions
- FrailtyKidney Disease, ChronicKidney Failure
- Interventions
- Dietary Supplement: Egg white protein pudding
- Registration Number
- NCT06343727
- Lead Sponsor
- Seven Oaks Hospital Chronic Disease Innovation Centre
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 54
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description : Standard dietary supplement Egg white protein pudding Participants will receive Ensure Plus at the end of their dialysis treatments 3-days per week. Egg white protein pudding Egg white protein pudding Participants will receive egg white pudding at the end of their dialysis treatments 3-days per week.
- Primary Outcome Measures
Name Time Method Weekly recruitment rate 12 months Number of new participants per weeks of active recruitment
Eligibility to randomization ratio Measured at the end of 12 weeks. A ratio of eligibility to randomization expressed as percentage will be collected at 12 months to investigate egg pudding intervention feasibility.
Adherence to Egg pudding Measured at the end of12 weeks Adherence to egg white product intervention calculated by consumption of \>75% dispensed egg white protein products.
- Secondary Outcome Measures
Name Time Method chloride Measured at the end of 12 weeks. Total blood chloride concentration in mmol/L
Hand grip strength 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.
Serum bicarbonate Measured at the end of 12 weeks. Serum bicarbonate concentration in milliequivalents per liter (mEq/L)
Calcium Measured at the end of 12 weeks. Total blood calcium concentration in mmol/L
Serum albumin Measured at the end of 12 weeks. Serum albumin is measured in grams per deciliter (g/dL)
Five rep chair stand time 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
Urine albumin Measured at the end of 12 weeks. Total urine albumin concentration in µg/min
Change in gait speed Measured at the end of 12 weeks. Gait speed is measured by the predetermined distance/time to walk that distance (e.g., 5m/__sec)
Tandem balance time Measured at the end of 12 weeks. Measured in Seconds
Potassium Measured at the end of 12 weeks. The total blood potassium concentration in mmol/L
HbA1c Measured at the end of 12 weeks. Total blood glucose concentration in mmol/L
Sodium Measured at the end of 12 weeks. The total sodium concentration in mmol/L
phosphorus Measured at the end of 12 weeks. The total blood phosphorus concentration in mmol/L