Effect of a DASH-Style Diet on Urinary Risk Factors for Kidney Stone Disease

NCT06210009 | Recruiting DMC

• 1 other identifier: IRB-300012217
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The true capacity for a healthy diet to improve urinary stone risk factors is not well-defined. The objective of this study is to measure the effect of adopting a healthy dietary pattern on kidney stone disease (KSD) risk. The working hypothesis is that a Dietary Approaches to Stop Hypertension (DASH)-style diet will improve 24-hour urine stone risk parameters. The approach to testing this hypothesis will be to randomize participants with KSD to a standardized DASH-style vs. Western-style diet for one week. The Bionutrition Unit of the Center for Clinical and Translational Science will provide all meals to participants. The rationale for this study is that by measuring the effect of a DASH-style diet on urinary stone risk parameters, a benchmark for future real-world, implementation studies will be established. Based on available evidence, this will be the first controlled diet study to assess the DASH dietary pattern for improving urinary stone risk parameters.

Conditions

Kidney Stone

Keywords

DASH diet; Western diet

Outcome Measures

Primary Outcomes (1)

• Difference between the two arms in supersaturation of calcium oxalate

  Supersaturation of calcium oxalate is an index reflecting the propensity for the formation and growth of the most common stone type (calcium oxalate), which is calculated using excretion rates including urinary volume, calcium, citrate, and oxalate.

  Days 6-7 of the assigned intervention

Secondary Outcomes (9)

• Difference between the two arms in supersaturation of calcium oxalate between the baseline and intervention periods

  Days 6-7 of the assigned intervention

• Difference between the two arms in supersaturation of uric acid

  Days 6-7 of the assigned intervention

• Difference between the two arms in supersaturation of calcium phosphate

  Days 6-7 of the assigned intervention

• Difference between the two arms in urine volume

  Days 6-7 of the assigned intervention

• Difference between the two arms in urine calcium

  Days 6-7 of the assigned intervention

Study Arms (2)

DASH-Style Diet

EXPERIMENTAL

For seven days, participants will consume a diet characterized by higher intake of fruits, vegetables, and low-fat dairy, in addition to whole grains, poultry, fish, and nuts, but smaller amounts of red meat, sweets, and sugar-containing beverages.

Other: DASH-Style Diet

Western-Style Diet

OTHER

For seven days, participants will consume a diet characterized by characterized by higher intake of red meat, sweets, and items containing added sugar, processed starches, and seed oils, in addition to lower intake of fruits, vegetables, and low-fat dairy.

Other: Western-Style Diet

Interventions

DASH-Style Diet OTHER

Participants will be randomized to a DASH-style diet

DASH-Style Diet

Western-Style Diet OTHER

Participants will be randomized to a Western-style diet

Western-Style Diet

Eligibility Criteria

• Age: 19 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Birmingham, AL area participants of the Coronary Artery Risk Development in Young Adults (CARDIA) study OR patients of the University of Alabama at Birmingham/Kirklin Clinic
• Self-reported, documented, and/or prior imaging-based diagnosis of kidney stone disease
• Age 19-89
• Any sex
• Any race
• Able to provide informed consent
• Willing to perform 24-hour urine collections
• Willing to consume meals prepared by Bionutrition Unit
• No food allergies/intolerance to any of the foods in the study menus
• Willing to stop for 7 days before and during study: Multivitamins and/or Dietary supplements (including calcium and vitamin C)

You may not qualify if:

• Dialysis
• Kidney transplant recipient
• Estimated glomerular filtration rate (eGFR) \<60 ml/min/1.73m2 based on historical laboratory measurements
• Renal tubular acidosis
• Current use of acetazolamide, topiramate, or zonisamide
• Primary hyperparathyroidism or history of parathyroidectomy
• Hyperthyroidism
• Sarcoidosis
• Primary hyperoxaluria
• Cystinuria
• Nephrotic syndrome
• Malabsorptive conditions including inflammatory bowel disease or history of malabsorptive surgery (e.g., Roux-en-Y gastric bypass, small bowel resection)
• Urinary retention requiring catheterization
• Urinary diversion
• Pregnancy

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Joseph Crivelli, MD

CONTACT

205-996-8765; crivelli@uab.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Urology

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 18, 2024
• Study Start: January 6, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

US (1)