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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DASH-Style Diet | Experimental | 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. |
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| Western-Style Diet | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DASH-Style Diet | Other | Participants will be randomized to a DASH-style diet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between the two arms in supersaturation of calcium oxalate | 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. | Days 6-7 of the assigned intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between the two arms in supersaturation of calcium oxalate between the baseline and intervention periods | This secondary outcome will be calculated using a difference in differences approach. | Days 6-7 of the assigned intervention |
| Difference between the two arms in supersaturation of uric acid |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joseph Crivelli, MD | Contact | 205-996-8765 | crivelli@uab.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35294 | United States |
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Western-Style Diet |
| Other |
Participants will be randomized to a Western-style diet |
|
Supersaturation of uric acid is an index reflecting the propensity for the formation and growth of uric acid stones. |
| Days 6-7 of the assigned intervention |
| Difference between the two arms in supersaturation of calcium phosphate | Supersaturation of calcium phosphate is an index reflecting the propensity for the formation and growth of calcium phosphate stones. | Days 6-7 of the assigned intervention |
| Difference between the two arms in urine volume | Low urine volume is a stone risk factor. | Days 6-7 of the assigned intervention |
| Difference between the two arms in urine calcium | High urine calcium is a stone risk factor. | Days 6-7 of the assigned intervention |
| Difference between the two arms in urine oxalate | High urine oxalate is a stone risk factor. | Days 6-7 of the assigned intervention |
| Difference between the two arms in urine citrate | Low urine citrate is a stone risk factor. | Days 6-7 of the assigned intervention |
| Difference between the two arms in urine uric acid | High urine uric acid is a stone risk factor. | Days 6-7 of the assigned intervention |
| Difference between the two arms in urine pH | Urine pH can influence stone formation and growth. | Days 6-7 of the assigned intervention |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |