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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT06210009
Status
Recruiting
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Conditions

  • Kidney Stone

Eligibility Criteria

Sex
ALL
Age
19 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • DASH-Style Diet — OTHER
    Participants will be randomized to a DASH-style diet
  • Western-Style Diet — OTHER
    Participants will be randomized to a Western-style diet

Study Details

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.

Key Dates

Start date
Jan 6, 2025
Status verified
Jan 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Joseph Crivelli, MD
[email protected]
205-996-8765

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