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

The University of Alabama at Birmingham

Status: Enrolling

Conditions: Kidney Stone

Treatments: Other: Western-Style Diet; Other: DASH-Style Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT06210009

IRB-300012217

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 19 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 2 patient groups

DASH-Style Diet

Experimental group

Description:

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.

Treatment:

Other: DASH-Style Diet

Western-Style Diet

Other group

Description:

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.

Treatment:

Other: Western-Style Diet