Recruiting

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

Sponsor:

University of Alabama at Birmingham

Code:

NCT06210009

Conditions

Kidney Stone

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

Interventions

DASH-Style Diet

Western-Style Diet

Study Details

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

Study ID

NCT06210009

Start date

Jan 6, 2025

Status verified date

Jan, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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)

Exclusion Criteria:

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
Breastfeeding
Malignancy treated in the past 12 months other than non-melanoma skin cancer

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: DASH-Style Diet

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: Western-Style Diet

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.

Interventions

DASH-Style Diet

Participants will be randomized to a DASH-style diet

Western-Style Diet

Participants will be randomized to a Western-style diet

Primary outcome measure

Difference between the two arms in supersaturation of calcium oxalate [ Time Frame: Days 6-7 of the assigned intervention ]

Central Contacts and Locations

Central contacts

Joseph Crivelli, MD

205-996-8765 crivelli@uab.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Joseph Crivelli, MD

205-996-8765 crivelli@uab.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Jan 13, 2026

Last verified

Jan, 2026

Keywords

DASH diet
Western diet

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-01-13.