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Whey Protein Supplement for Kidney Failure

N/A
Waitlist Available
Led By Jeanette M Andrade, PhD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years old or older
No chewing/swallowing difficulties
Must not have
CKD patient stages 1-4
CKD patient undergoing hemodialysis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months of the study
Awards & highlights
No Placebo-Only Group

Summary

This trial investigates how whey protein isolate supplements might affect protein status & quality of life over 6 months. Eligible participants sign a consent form & are given supplements to take with water.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include digestive discomfort due to increased protein intake such as bloating or gas. Since it's a nutritional supplement, severe side effects are unlikely but individual reactions can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
Select...
I have no issues with chewing or swallowing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My kidney disease is between stages 1 to 4.
Select...
I am a patient with chronic kidney disease receiving hemodialysis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months of the study
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months of the study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Serum albumin
Secondary study objectives
Total protein
mid-arm muscle circumference
normalized protein catabolic rate (nPCR)

Side effects data

From 2012 Phase 1 & 2 trial • 208 Patients • NCT00421408
29%
Mild to moderate gastro-intestinal upset
2%
Skin disorders
2%
Vertigo
2%
Arthritis
2%
Shingles
1%
Dry mouth
1%
Basal squamous cells removed from right cheek
1%
Increased duration of heart palpitations
1%
Car accident
1%
Outpatient hernia surgery
1%
Hyperglycemia
1%
Anemia
1%
Bruise and bleeding post blood draw
1%
Kidney stone
1%
Bursa removed from right knee
1%
Pain
1%
Broken bone
1%
Asthmatic bronchitis
1%
Hernia surgery
1%
Colon resection
1%
Acute pancreatitits
1%
Hip replacement
1%
Fluid retention
1%
Acute renal failure following cardiac cath procedure
1%
Elevated cholesterol
1%
Pain in lower left quadrant
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Carbohydrate Powder 40 g Daily
Protein Powder 40 g Daily

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Whey protein consumptionExperimental Treatment1 Intervention
Participants will receive 20g total protein of whey protein isolate in 115 mls of water to consume daily for up to 6 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Whey protein supplement
2016
Completed Phase 2
~390

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,404 Previous Clinical Trials
766,354 Total Patients Enrolled
Jeanette M Andrade, PhDPrincipal InvestigatorUniversity of Florida
2 Previous Clinical Trials
82 Total Patients Enrolled
~1 spots leftby Mar 2025
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