RECRUITING

Protein Sources Urinary Stone Risk

Conditions

Kidney Stone Prevention Nephrolithiasis Kidney stones Protein

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

The Effect of Protein Sources on Urinary Stone Risk

Quick Facts

Study Start:2022-10-30

Study Completion:2023-07-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05460247

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Willing and able to complete the study 2. Healthy with no personal or family history of kidney stones	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)

Inclusion Criteria

Exclusion Criteria

1. Willing and able to complete the study
2. Healthy with no personal or family history of kidney stones

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)

Contacts and Locations

Study Contact

Linda Black

CONTACT

3143936572

Blackl@wustl.edu

Study Locations (Sites)

Washington University

Saint Louis, Missouri, 63110

United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-30

Study Completion Date2023-07-30

Study Record Updates

Study Start Date2022-10-30

Study Completion Date2023-07-30

Terms related to this study

Keywords Provided by Researchers

Nephrolithiasis
Kidney stones
Protein

Additional Relevant MeSH Terms

Kidney Stone Prevention