Frailty, Kidney Disease, Chronic, Kidney Failure
Conditions
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. 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_SUPPLEMENTEgg 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
Sponsors
Seven Oaks Hospital Chronic Disease Innovation Centre
University of Manitoba
Manitoba Egg Farmers
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
This trial is an open-label randomized controlled parallel arm feasibility trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eligibility to randomization ratio | 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. |
| Recruitment rate | 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 |
| Follow up rate | 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. |
| Adherence to Intervention | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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) |
| 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 |
| Tandem balance time | Measured at the end of 12 weeks. | Measured in Seconds |
| Serum albumin | Measured at the end of 12 weeks. | Serum albumin is measured in grams per deciliter (g/dL) |
| 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 |
| chloride | Measured at the end of 12 weeks. | Total blood chloride concentration in mmol/L |
| phosphorus | Measured at the end of 12 weeks. | The total blood phosphorus concentration in mmol/L |
| Potassium | Measured at the end of 12 weeks. | The total blood potassium concentration in mmol/L |
| Sodium | Measured at the end of 12 weeks. | The total sodium concentration in mmol/L |
| HbA1c | Measured at the end of 12 weeks. | Total blood glucose concentration in mmol/L |
| Dry Weight | Measured at the end of 12 weeks | Measured in kg |
| Height | Measured at the end of 12 weeks | Measured in cm |
| Pre-dialysis Blood pressure | Measured at the end of 12 weeks | Systolic and diastolic blood pressure measured in mmHg |
Countries
Canada
Contacts
CONTACTNavdeep Tangri, MD, PhD
CONTACTTahmina Rahman, MSc
Outcome results
None listed