Protein Sources Urinary Stone Risk

NCT ID: NCT05460247

Last Updated: 2023-04-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-30
• Study Completion Date: 2023-07-30

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.

Conditions

Kidney Stone Prevention

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pea protein diet

Group Type: EXPERIMENTAL

Protein

Intervention Type: DIETARY_SUPPLEMENT

Participants will receive a diet supplemented by the above protein

Whey protein diet

Group Type: EXPERIMENTAL

Protein

Intervention Type: DIETARY_SUPPLEMENT

Participants will receive a diet supplemented by the above protein

Soy protein

Group Type: EXPERIMENTAL

Protein

Intervention Type: DIETARY_SUPPLEMENT

Participants will receive a diet supplemented by the above protein

Rice protein

Group Type: EXPERIMENTAL

Protein

Intervention Type: DIETARY_SUPPLEMENT

Participants will receive a diet supplemented by the above protein

Interventions

Protein

Participants will receive a diet supplemented by the above protein

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Washington University

St Louis, Missouri, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Linda Black

Role: CONTACT

Blackl@wustl.edu

3143936572

Facility Contacts

Daniel Wong, MD

Role: primary

Other Identifiers

Proteinsourcesv1

Identifier Type: -

Identifier Source: org_study_id