A High Protein Egg White Pudding for People With Kidney Failure (HiPE KF)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSeven Oaks Hospital Chronic Disease Innovation Centre
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Allergy to eggs
History of renal transplant
Serum albumin ≥ 35 g/L
Bowel diseases
Trial design
Design model
Parallel
Treatments tested in this trial
Egg white protein pudding
Dietary supplementWill consume one egg white protein pudding at the end of their dialysis treatments 3-days per week for 12 weeks
: Ensure Plus
Dietary supplementWill consume one Ensure Plus at the end of their dialysis treatments 3-days per week for 12 weeks
Treatment groups
54 Participants
are divided into 2 treatment groupsGroup A: Egg white protein puddingExperimental treatment 1 intervention
Group B: : Standard dietary supplementActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Eligibility to randomization ratio
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.
Time frame
Measured at the end of 12 weeks.2
Recruitment rate
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
Time frame
12 months3
Follow up rate
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.
Time frame
Measured at the end of 12 weeks.4
Adherence to Intervention
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
Time frame
Measured at the end of12 weeksSecondary outcomes
1
Hand grip strength
Measuring the amount of static force that the hand can squeeze around a dynamometer. Measured in kilograms and pounds.
Time frame
Measured at the end of 12 weeks.2
Change in gait speed
Gait speed is measured by the predetermined distance/time to walk that distance (e.g., 5m/\_\_sec)
Time frame
Measured at the end of 12 weeks.3
Five rep chair stand time
the amount of time it takes for a participant to get up out of a chair five times measured in seconds
Time frame
Measured at the end of 12 weeks.4
Tandem balance time
Measured in Seconds
Time frame
Measured at the end of 12 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Seven Oaks Hospital Chronic Disease Innovation Centre
Lead sponsor
University of Manitoba
Collaborator
Manitoba Egg Farmers
Collaborator
Source ClinicalTrials.gov