NCT05460247

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 15, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

October 30, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
Last Updated

April 24, 2023

Status Verified

April 1, 2023

Enrollment Period

8 months

First QC Date

July 12, 2022

Last Update Submit

April 20, 2023

Conditions

Kidney Stone Prevention

Keywords

NephrolithiasisKidney stonesProtein

Outcome Measures

Primary Outcomes (2)

  • Urinary stone risk

    24 hour urine panel and supersaturation for Calcium Oxalate and Uric Acid

    3 months after beginning study

  • Calcium Oxalate Inhibitor activity

    mmol of Oxalate added before spontaneous precipitation

    3-6 months after beginning study

Study Arms (4)

Pea protein diet

EXPERIMENTAL
Dietary Supplement: Protein

Whey protein diet

EXPERIMENTAL
Dietary Supplement: Protein

Soy protein

EXPERIMENTAL
Dietary Supplement: Protein

Rice protein

EXPERIMENTAL
Dietary Supplement: Protein

Interventions

ProteinDIETARY_SUPPLEMENT

Participants will receive a diet supplemented by the above protein

Pea protein dietRice proteinSoy proteinWhey protein diet

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)
  • 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)
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

RECRUITING

MeSH Terms

Conditions

NephrolithiasisKidney Calculi

Interventions

Proteins

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital DiseasesUrinary CalculiCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Central Study Contacts

Linda Black

CONTACT

3143936572Blackl@wustl.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2022

First Posted

July 15, 2022

Study Start

October 30, 2022

Primary Completion

June 30, 2023

Study Completion

July 30, 2023

Last Updated

April 24, 2023

Record last verified: 2023-04

Locations

US(1)