Protein Sources Urinary Stone Risk

Sponsor

Washington University School of Medicine (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05460247

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Stone Prevention	Dietary Supplement: Protein	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

14 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

The Effect of Protein Sources on Urinary Stone Risk

Anticipated Study Start Date :

Jul 30, 2022

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jul 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pea protein diet	Dietary Supplement: Protein Participants will receive a diet supplemented by the above protein
Experimental: Whey protein diet	Dietary Supplement: Protein Participants will receive a diet supplemented by the above protein
Experimental: Soy protein	Dietary Supplement: Protein Participants will receive a diet supplemented by the above protein
Experimental: Rice protein	Dietary Supplement: Protein Participants will receive a diet supplemented by the above protein

Outcome Measures

Primary Outcome Measures

Urinary stone risk [3 months after beginning study]
24 hour urine panel and supersaturation for Calcium Oxalate and Uric Acid
Calcium Oxalate Inhibitor activity [3-6 months after beginning study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Washington University School of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Washington University School of Medicine

ClinicalTrials.gov Identifier:

NCT05460247

Other Study ID Numbers:

Proteinsourcesv1

First Posted:

Jul 15, 2022

Last Update Posted:

Jul 15, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Washington University School of Medicine

24 hour urine, Nephrolithiasis

Additional relevant MeSH terms:

Kidney Calculi

Urinary Calculi

Urolithiasis

Study Results

No Results Posted as of Jul 15, 2022