Protein Sources Urinary Stone Risk

Phase

N/A

Condition

Kidney Stones

Treatment

N/A

Clinical Study ID

NCT05460247

Proteinsourcesv1

Ages 18-75
All Genders
Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 tubularacidosis
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/yearproven 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 toenrollment)
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 investigatorfeels will impact participant's ability to complete study activities)

Study Design

October 30, 2022

July 30, 2023

Study 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.

Connect with a study center

Washington University
Saint Louis, Missouri 63110
United States
Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.