Purpose

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.

Condition

Eligibility

Eligible Ages
Between 19 Years and 89 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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: DASH-Style Diet
    Participants will be randomized to a DASH-style diet
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.
  • Other: Western-Style Diet
    Participants will be randomized to a Western-style diet

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294
Contact:
Joseph Crivelli, MD
205-996-8765
crivelli@uab.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Joseph Crivelli, MD
205-996-8765
crivelli@uab.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.