Clinical trial NCT04073719: Apple Cider Vinegar for the Prevention of Urinary Lithiasis (APUL)
Official title: Apple Cider Vinegar for the Prevention of Urinary Lithiasis (APUL)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Stones, Urolithiasis, Hypocitraturia
Keywords: Kidney Stones, Urolithiasis, Hypocitraturia, Apple Cider Vinegar
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
First posted: 2019-08-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Prospective randomized sample of 36 patients, in a nested cross over design.
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess whether certain beverages can increase urinary citrate levels in healthy individuals with no history of kidney disease.

Detailed description: Higher urinary citrate levels have been shown to decrease one's risk of developing kidney stones. The study will compare apple cider vinegar, coconut water, diet citric soda and lemonade and determine which is superior at raising citrate levels. Research participants will consume two of the four drinks, each for 7 day periods, according to a prescribed regimen. Throughout the course of the study, participants will periodically provide blood draws for metabolic panels, as well as 24-hour urine samples to measure citrate levels. There will be 12 study arms, accounting for the permutations of two drinks for each patients out of four possibilities. 3 participants per arm is the goal, for a total of 36, but the recruitment aim is 50 participants, to account for dropout and noncompliance.

Eligibility criteria: Inclusion Criteria:

* Male and female volunteers 18-65 years old

Exclusion Criteria:

* History of peptic ulcer disease or gastroparesis
* Pregnant females
* History of chronic kidney disease
* History of urolithiasis
* Currently taking medications that interfere with urinary electrolyte excretion (thiazide and loop diuretics)javascript:document.
* History of Diabetes

Primary outcomes:
measure: Apple Cider Vinegar Urinary Citrate Increase
timeFrame: 1 week
Secondary outcomes:
measure: Apple Cider Vinegar and urinary pH
timeFrame: 1 week
measure: Apple Cider Vinegar Against Other Beverages
timeFrame: 4 weeks
measure: Palatability Evaluation
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References:
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