[logo] HealthTree Foundation
search more_vert
close
person Sign In / Create Account
arrow_back

Go back to trials list

The Effect of Protein Sources on Urinary Stone Risk


Description

Prior studies have shown that the source of dietary protein can have a significant impact on urinary stone risk. However, whey and plant protein isolates have not been compared. This is an important distinction as protein supplements fortified foods are increasingly popular. Herein, we seek to investigate the effect of different protein supplements, in an otherwise identical diet, on urinary stone risk.Each participant will receive a pre-made diet for 5 days at a time, for a total of 4 cycles. Previous studies have shown urine values reach a constant within the first 3 days. Diet will be a constant baseline diet representative of a standard Mediterranean diet. Participants will receive this diet to eat at home for 5 days with a supplemental protein shake at each meal (3 times a day). Participants will be required to drink 2.5-3 liters of fluid daily. Caffeine may be ingested as caffeine pills. Excessive exercise will be discouraged during the treatment phase. Diet will remain constant

Trial Eligibility

Inclusion Criteria: 1. Willing and able to complete the study 2. Healthy with no personal or family history of kidney stones Exclusion Criteria: 1. Allergy to any protein isolates or menu items used in the study 2. History of calcium oxalate, cysteine, uric acid, or infection stones 3. Disorders of absorption: Celiac disease, Irritable Bowel Disease, chronic diarrhea, short gut 4. Systemic predisposition to stones: gout, congenital hyperuricemia, chronic diarrhea, insulin resistance, neoplastic disorders, hyperparathyroidism or renal tubular acidosis 5. Women who are currently pregnant or planning pregnancy within 2 years 6. Renal transplant recipient 7. Bedridden study participants (ECOG ≥ 3) 8. Uncorrected anatomical obstruction of the urinary tract 9. History of recurrent urinary tract infections (\> 3 urinary tract infections/year proven by urine culture) 10. Exclusions due to medication use: 1. Chronic use of lithium 2. Long-term glucocorticoid use (\> 7.5 mg prednisone daily for \> 30 days prior to enrollment) 3. Intake of narcotic medication on a daily basis for \>30 days prior to enrollment 4. Supplemental Vitamin C (\> 1 g daily) 5. Carbonic anhydrase inhibitors (acetazolamide, topiramate, zonisamide) 6. high dose calcium supplementation (\> 1,200 mg daily) 7. Medications that may crystallize in the urine (guaifenesin, sulfonamides, triamterene, and the protease inhibitors indinavir and nelfinavir). 11. Non-English Speakers 12. History of Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) 13. Anatomical urologic abnormalities including ileal conduits, horseshoe kidney, megaureter or solitary kidney 14. Psychiatric conditions impairing compliance with the study 15. Vulnerable population (prisoner and/or cognitive impairment that the investigator feels will impact participant's ability to complete study activities)

Study Info

Organization

Washington University School of Medicine


Primary Outcome

Urinary stone risk


Outcome Timeframe 3 months after beginning study

NCTID NCT05460247

Phases NA

Primary Purpose TREATMENT

Start Date 2022-10-30

Completion Date 2023-06-30

Enrollment Target 14

Interventions

DIETARY_SUPPLEMENT Protein

Locations Recruiting

Washington University

United States, Missouri, Saint Louis


Interested in joining this trial?

Our dedicated patient navigators are here to guide you through the validation and enrollment process with ease.

newsletter icon

Get the latest thought leadership on your Kidney Disease delivered straight to your inbox

Subscribe to the weekly newsletter for news, stories, clinical trial updates, and helpful resources and events with cancer experts.