Clinical trial NCT06210009: Effect of a DASH-Style Diet on Urinary Risk Factors for Kidney Stone Disease
Official title: Effect of a DASH-Style Diet on Urinary Risk Factors for Kidney Stone Disease: A Randomized Controlled Trial (CARDIA Ancillary Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Stone
Keywords: DASH diet
Western diet
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference between the two arms in supersaturation of calcium oxalate
timeFrame: Days 6-7 of the assigned intervention
Secondary outcomes:
measure: Difference between the two arms in supersaturation of calcium oxalate between the baseline and intervention periods
timeFrame: Days 6-7 of the assigned intervention
measure: Difference between the two arms in supersaturation of uric acid
timeFrame: Days 6-7 of the assigned intervention
measure: Difference between the two arms in supersaturation of calcium phosphate
timeFrame: Days 6-7 of the assigned intervention
measure: Difference between the two arms in urine volume
timeFrame: Days 6-7 of the assigned intervention
measure: Difference between the two arms in urine calcium
timeFrame: Days 6-7 of the assigned intervention
measure: Difference between the two arms in urine oxalate
timeFrame: Days 6-7 of the assigned intervention
measure: Difference between the two arms in urine citrate
timeFrame: Days 6-7 of the assigned intervention
measure: Difference between the two arms in urine uric acid
timeFrame: Days 6-7 of the assigned intervention
measure: Difference between the two arms in urine pH
timeFrame: Days 6-7 of the assigned intervention
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References: