Whey Protein Supplement for Kidney Failure

No longer recruiting at 1 trial location

Overseen By Jeanette M Andrade, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Pregnant, Lactating, Protein supplements, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the effects of a daily whey protein supplement on protein levels and quality of life in individuals with stage 5 Chronic Kidney Disease undergoing peritoneal dialysis. Participants will consume a specific amount of whey protein mixed with water daily for six months. The trial evaluates whether this supplement helps maintain healthy protein levels and enhances overall well-being. Suitable candidates have stage 5 Chronic Kidney Disease, have been on peritoneal dialysis for at least three months, and have no dietary restrictions or food allergies. As an unphased trial, this study offers participants the chance to contribute to valuable research that could improve the quality of life for others with similar conditions.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that you cannot use other protein supplements during the trial.

What prior data suggests that this whey protein supplement is safe for kidney failure patients?

Research has shown that whey protein supplements are generally safe for use. One study examined the effects of protein powders, including whey protein, on the kidneys and found no harm to kidney health. Another review found no major changes in kidney function when comparing different groups using protein supplements.

However, some safety information remains incomplete. While many people use whey protein without issues, individual reactions can vary. Before joining a trial or starting a new supplement, consulting a healthcare provider is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for kidney failure, which often involve medications and dialysis, the whey protein supplement being studied is derived from whey protein isolate. Researchers are excited about it because whey protein is a natural source of high-quality protein that may help improve nutritional status and muscle health without the need for invasive procedures. This supplement is unique as it provides a simple, daily dietary addition that could support kidney function and overall health in a more holistic way.

What evidence suggests that whey protein supplement might be an effective treatment for kidney failure?

Research has shown that whey protein supplements can benefit people with kidney problems, especially those on hemodialysis. One study found that special whey protein supplements for kidney health improved patients' nutrition, as evidenced by better protein levels and overall health indicators. Another study demonstrated that these supplements help maintain muscle mass, crucial for health in kidney failure. In this trial, participants will receive a daily dose of whey protein isolate to assess its effects on kidney health. While whey protein is generally safe, monitoring intake is important to avoid extra strain on the kidneys. Overall, whey protein supplements are considered beneficial for improving nutrition in people with kidney failure. ^{2 6 7 8 9}

Who Is on the Research Team?

Jeanette M Andrade, PhD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

Adults over 18 with stage 5 chronic kidney disease (CKD) who have been on peritoneal dialysis for at least three months. Participants must be able to sign consent, have no dietary restrictions, food allergies, or issues with chewing/swallowing. Pregnant or lactating individuals and those using other protein supplements are excluded.

Inclusion Criteria

I have been diagnosed with stage 5 kidney disease for at least 3 months.

Can provide signed informed consent

I have no issues with chewing or swallowing.

Exclusion Criteria

Use of other protein supplement

Pregnant/lactating as either self-reported or determined by the medical director

My kidney disease is between stages 1 to 4.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3 months

Treatment

Participants receive 20g total protein of whey protein isolate in 115 mls of water daily

6 months

Monthly visits for blood collection and measurements

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Whey protein supplement

Trial Overview

The trial is testing if a whey protein isolate supplement can improve the protein status in adults undergoing peritoneal dialysis. Over six months, participants' blood will be checked monthly for certain proteins and their body measurements taken to see any changes in nutrition and quality of life.

How Is the Trial Designed?

Group I: Whey protein consumption Experimental Treatment 1 Intervention

Participants will receive 20g total protein of whey protein isolate in 115 mls of water to consume daily for up to 6 months

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Citations

1.

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2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2405457718302651

Clinical efficacy and feasibility of whey protein isolates ...

Kidney Disease Outcomes Quality Initiative. Kt/V. Dialysis adequacy ... Effects of renal-specific oral supplementation in malnourished hemodialysis patients.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7212094/

Oral protein‐based supplements versus placebo or no ...

tw. Chronic Kidney Disease/. Kidney Failure/. Chronic Kidney Failure/ ... Use of a renal-specific oral supplement by haemodialysis patients with low protein ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10079511/

Efficacy and safety assessment of protein supplement

Changes in kidney function test parameters between groups. Laboratory ... Plant protein are linked with benefits for health and physical function.

5.

systematicreviewsjournal.biomedcentral.com

systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-019-1039-z

Effectiveness of whey protein supplements on the serum ...

Hydrolysed whey protein reduces muscle damage ... Acute kidney injury due to rhabdomyolysis and renal replacement therapy: a critical review.

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0378427425018314

P06-11 Investigation of the Effects of Protein Powders on ...

... safety, particularly in relation to kidney function and possible contamination with heavy metals. ... Renal toxicity parameters included urine pH, protein ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10994440/

Citizens protein project: A self-funded, transparent, and ...

... renal and liver damage, and malignancy. The presence of arsenic ... diseases, impaired brain development and functioning, and kidney and liver ...

8.

health.clevelandclinic.org

health.clevelandclinic.org/is-whey-protein-good-for-you

Is Whey Protein Good for You?

... safety data is lacking. Person holding bottle of vitamins, reading the ... DiseaseLungOral HealthParentingPregnancy & ChildbirthRecipes ...

9.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06154161

Examining the Impact of High-protein Oral Supplement on ...

Protein Deficiency. Deficiency Diseases. Malnutrition. Nutrition Disorders. Nutritional and Metabolic Diseases. Renal Insufficiency. Protein-Energy Malnutrition ...