Egg White Protein Pudding for Kidney Failure

Recruiting at 1 trial location

Overseen By Tahmina Rahman, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Seven Oaks Hospital Chronic Disease Innovation Centre

Disqualifiers: Egg allergy, Renal transplant, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

54 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether an egg white protein pudding can benefit people with kidney failure who are on dialysis. Researchers aim to determine if this pudding can improve blood protein levels, similar to standard supplements like Ensure Plus. Participants will receive either the egg white pudding or Ensure Plus after their dialysis sessions three times a week for 12 weeks. This trial suits individuals who have been undergoing hemodialysis for over three months, have low blood protein levels, and have no egg allergies. As an unphased trial, it provides a unique opportunity to explore a potentially beneficial dietary option for enhancing protein levels.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that egg whites can be a safe choice for people with kidney problems. In healthy individuals, studies have found that egg white protein is as easy to digest as chicken protein. Experiences with dialysis patients suggest that a liquid egg white product is usually well-tolerated as a protein substitute for one meal a day. This indicates that egg white protein pudding might be a safe option for those on dialysis. While no specific negative effects have been reported, using egg whites in kidney diets appears promising for maintaining stable protein levels. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard dietary supplements often used for kidney failure, such as Ensure Plus, egg white protein pudding introduces a novel approach by delivering high-quality protein in a palatable form at the end of dialysis sessions. Researchers are excited because egg whites offer a rich source of protein with minimal phosphorus, a significant advantage for kidney patients who need to manage their phosphorus intake. This treatment might improve nutrition without the phosphorus-related complications that can arise with other protein sources, making it a potentially safer and more effective option for kidney health.

What evidence suggests that this trial's treatments could be effective for kidney failure?

Research shows that egg whites are an excellent protein source for people with chronic kidney disease (CKD). Studies have found that replacing meat with egg whites can lower phosphorus levels in dialysis patients, which is crucial because high phosphorus can be harmful in CKD. Egg whites also provide calories, helping meet the higher energy needs of those with kidney failure. Early research suggests that egg white protein can maintain or improve protein levels in the blood, similar to other nutritional supplements. In this trial, participants will receive either egg white protein pudding or Ensure Plus at the end of their dialysis treatments. These benefits make egg white protein pudding a promising option for improving health in dialysis patients with kidney failure. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with kidney failure on dialysis, specifically those who have low serum albumin levels (<35 g/L) and have been receiving in-center hemodialysis for over 3 months. Participants should not anticipate changes in their dialysis approach or plan to move away from Winnipeg during the 12-week study period.

Inclusion Criteria

I am willing and able to agree to participate in the trial.

I won't change my dialysis type or move from Winnipeg for the next 12 weeks.

My blood protein level is below 35 g/L.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either egg white pudding or Ensure Plus at the end of their dialysis treatments 3-days per week for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Egg White Protein Pudding
• Ensure Plus

Trial Overview The trial compares two protein supplements: an experimental egg white protein pudding versus a standard supplement, Ensure Plus. It aims to see if the pudding is feasible as a supplement, can improve serum albumin levels, and affect frailty measures along with dietary intakes and blood/urine analytes.

How Is the Trial Designed?

Group I: Egg white protein pudding Experimental Treatment 2 Interventions

Participants will receive egg white pudding at the end of their dialysis treatments 3-days per week.

Group II: : Standard dietary supplement Active Control 2 Interventions

Participants will receive Ensure Plus at the end of their dialysis treatments 3-days per week.

Who Is Running the Clinical Trial?

Seven Oaks Hospital Chronic Disease Innovation Centre

Lead Sponsor

Trials

4

Recruited

210+

Manitoba Egg Farmers

Collaborator

Trials

1

Recruited

50+

University of Manitoba

Collaborator

Trials

628

Recruited

209,000+

Citations

1. ctv.veeva.com ctv.veeva.com/study/a-high-protein-egg-white-pudding-for-people-with-kidney-failure-hipe-kf

A High Protein Egg White Pudding for People With Kidney ... The goal of this clinical trial is to compare protein supplements in patients with kidney failure on dialysis. The main questions it aims to ...

2. withpower.com withpower.com/trial/phase-chronic-kidney-disease-ckd-4-2024-6d007

Egg White Protein Pudding for Kidney Failure 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6315879/

Egg Intake in Chronic Kidney Disease - PMC Whole eggs provide a nutrient-dense source of calories to meet the increased energy demands of CKD patients.

4. davita.com davita.com/diet-nutrition/articles/using-egg-whites-to-keep-protein-up-and-control-phosphorus/

Using Egg Whites to Keep Protein Up and Control ... Overall, Lynn found that 92 percent of dialysis patients in the study decreased their phosphorus levels when they substituted liquid egg white for meat in one ...

5. clinconnect.io clinconnect.io/trials/NCT06343727

A High Protein Egg White Pudding for People With Kidney This clinical trial, called the HiPE KF study, is looking into the effects of a high protein egg white pudding on people with kidney failure who are on dialysis ...

6. trial.medpath.com trial.medpath.com/clinical-trial/270ab2f84fb03926/high-protein-egg-white-pudding-kidney-failure

A High Protein Egg White Pudding for People With Kidney ... * To determine the effects of the egg white protein pudding on frailty measures, dietary intakes and analytes in the blood and urine.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/20649063/

Renal response to egg white protein loading in healthy ... Conclusion: In normal subjects, egg white protein stimulated as high renal response as chicken protein when challenged with the same amount of protein.