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Protein Sources Urinary Stone Risk

Primary Purpose

Kidney Stone Prevention

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Protein
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Stone Prevention focused on measuring Nephrolithiasis, Kidney stones, Protein

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Washington UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Pea protein diet

Whey protein diet

Soy protein

Rice protein

Arm Description

Outcomes

Primary Outcome Measures

Urinary stone risk
24 hour urine panel and supersaturation for Calcium Oxalate and Uric Acid
Calcium Oxalate Inhibitor activity
mmol of Oxalate added before spontaneous precipitation

Secondary Outcome Measures

Full Information

First Posted
July 12, 2022
Last Updated
April 20, 2023
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05460247
Brief Title
Protein Sources Urinary Stone Risk
Official Title
The Effect of Protein Sources on Urinary Stone Risk
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 30, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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 with respect to protein quantity and all other ingredients and will only change protein isolate source in supplemental protein shake. On days 4 and 5 of the diet, participants will be asked to collect two consecutive 24-hour urines. Between each 5-day diet phase, a flexible washout period will be allowed in which participants may eat a self-selected diet to take a break from standardized meals. Participants may resume the next phase diet on a day which is convenient for planned 24-hour urine collection at the end of that phase. The break period is to last no longer than 10 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stone Prevention
Keywords
Nephrolithiasis, Kidney stones, Protein

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pea protein diet
Arm Type
Experimental
Arm Title
Whey protein diet
Arm Type
Experimental
Arm Title
Soy protein
Arm Type
Experimental
Arm Title
Rice protein
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein
Intervention Description
Participants will receive a diet supplemented by the above protein
Primary Outcome Measure Information:
Title
Urinary stone risk
Description
24 hour urine panel and supersaturation for Calcium Oxalate and Uric Acid
Time Frame
3 months after beginning study
Title
Calcium Oxalate Inhibitor activity
Description
mmol of Oxalate added before spontaneous precipitation
Time Frame
3-6 months after beginning study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Willing and able to complete the study Healthy with no personal or family history of kidney stones Exclusion Criteria: Allergy to any protein isolates or menu items used in the study History of calcium oxalate, cysteine, uric acid, or infection stones Disorders of absorption: Celiac disease, Irritable Bowel Disease, chronic diarrhea, short gut Systemic predisposition to stones: gout, congenital hyperuricemia, chronic diarrhea, insulin resistance, neoplastic disorders, hyperparathyroidism or renal tubular acidosis Women who are currently pregnant or planning pregnancy within 2 years Renal transplant recipient Bedridden study participants (ECOG ≥ 3) Uncorrected anatomical obstruction of the urinary tract History of recurrent urinary tract infections (> 3 urinary tract infections/year proven by urine culture) Exclusions due to medication use: Chronic use of lithium Long-term glucocorticoid use (> 7.5 mg prednisone daily for > 30 days prior to enrollment) Intake of narcotic medication on a daily basis for >30 days prior to enrollment Supplemental Vitamin C (> 1 g daily) Carbonic anhydrase inhibitors (acetazolamide, topiramate, zonisamide) high dose calcium supplementation (> 1,200 mg daily) Medications that may crystallize in the urine (guaifenesin, sulfonamides, triamterene, and the protease inhibitors indinavir and nelfinavir). Non-English Speakers History of Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) Anatomical urologic abnormalities including ileal conduits, horseshoe kidney, megaureter or solitary kidney Psychiatric conditions impairing compliance with the study Vulnerable population (prisoner and/or cognitive impairment that the investigator feels will impact participant's ability to complete study activities)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Linda Black
Phone
3143936572
Email
Blackl@wustl.edu
Facility Information:
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Wong, MD

12. IPD Sharing Statement

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Protein Sources Urinary Stone Risk

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