Effect of a DASH-Style Diet on Urinary Risk Factors for Kidney Stone Disease
- Conditions
- Kidney Stone
- Interventions
- Other: DASH-Style DietOther: Western-Style Diet
- Registration Number
- NCT06210009
- Lead Sponsor
- University of Alabama at Birmingham
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 48
- 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)
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DASH-Style Diet 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. Western-Style Diet 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.
- Primary Outcome Measures
Name Time Method Difference between the two arms in supersaturation of calcium oxalate Days 6-7 of the assigned intervention 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.
- Secondary Outcome Measures
Name Time Method Difference between the two arms in supersaturation of uric acid Days 6-7 of the assigned intervention Supersaturation of uric acid is an index reflecting the propensity for the formation and growth of uric acid stones.
Difference between the two arms in urine uric acid Days 6-7 of the assigned intervention High urine uric acid is a stone risk factor.
Difference between the two arms in supersaturation of calcium phosphate Days 6-7 of the assigned intervention Supersaturation of calcium phosphate is an index reflecting the propensity for the formation and growth of calcium phosphate stones.
Difference between the two arms in urine volume Days 6-7 of the assigned intervention Low urine volume is a stone risk factor.
Difference between the two arms in urine oxalate Days 6-7 of the assigned intervention High urine oxalate is a stone risk factor.
Difference between the two arms in urine citrate Days 6-7 of the assigned intervention Low urine citrate is a stone risk factor.
Difference between the two arms in urine calcium Days 6-7 of the assigned intervention High urine calcium is a stone risk factor.
Difference between the two arms in urine pH Days 6-7 of the assigned intervention Urine pH can influence stone formation and growth.
Difference between the two arms in supersaturation of calcium oxalate between the baseline and intervention periods Days 6-7 of the assigned intervention This secondary outcome will be calculated using a difference in differences approach.
Trial Locations
- Locations (1)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States