Apple Cider Vinegar for the Prevention of Urinary Lithiasis (APUL)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 50
- Primary Endpoint
- Apple Cider Vinegar Urinary Citrate Increase
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Lemonade + Coconut Water
Patients will drink lemonade for 7 days. After a washout period of 2 weeks, patients will then drink coconut water for 7 days.
Intervention: Other Beverage (Dietary Supplement)
Lemonade + Citric Soda
Patients will drink lemonade for 7 days. After a washout period of 2 weeks, patients will then drink citric soda for 7 days.
Intervention: Other Beverage (Dietary Supplement)
Coconut Water + Citric Soda
Patients will drink coconut water for 7 days. After a washout period of 2 weeks, patients will then drink citric soda for 7 days.
Intervention: Other Beverage (Dietary Supplement)
Coconut Water + Lemonade
Patients will drink coconut water for 7 days. After a washout period of 2 weeks, patients will then drink lemonade for 7 days.
Intervention: Other Beverage (Dietary Supplement)
Citric Soda + Apple Cider Vinegar
Patients will drink citric soda for 7 days. After a washout period of 2 weeks, patients will then drink apple cider vinegar for 7 days.
Intervention: Other Beverage (Dietary Supplement)
Citric Soda + Coconut Water
Patients will drink citric soda for 7 days. After a washout period of 2 weeks, patients will then drink coconut water for 7 days.
Intervention: Other Beverage (Dietary Supplement)
Citric Soda + Lemonade
Patients will drink citric soda for 7 days. After a washout period of 2 weeks, patients will then drink lemonade for 7 days.
Intervention: Other Beverage (Dietary Supplement)
Apple Cider Vinegar + Citric Soda
Patients will drink apple cider vinegar for 7 days. After a washout period of 2 weeks, patients will then drink citric soda for 7 days.
Intervention: Apple Cider Vinegar (Dietary Supplement)
Lemonade + Apple Cider Vinegar
Patients will drink lemonade for 7 days. After a washout period of 2 weeks, patients will then drink apple cider vinegar for 7 days.
Intervention: Apple Cider Vinegar (Dietary Supplement)
Citric Soda + Apple Cider Vinegar
Patients will drink citric soda for 7 days. After a washout period of 2 weeks, patients will then drink apple cider vinegar for 7 days.
Intervention: Apple Cider Vinegar (Dietary Supplement)
Coconut Water + Apple Cider Vinegar
Patients will drink coconut water for 7 days. After a washout period of 2 weeks, patients will then drink apple cider vinegar for 7 days.
Intervention: Apple Cider Vinegar (Dietary Supplement)
Apple Cider Vinegar + Lemonade
Patients will drink apple cider vinegar for 7 days. After a washout period of 2 weeks, patients will then drink lemonade for 7 days.
Intervention: Apple Cider Vinegar (Dietary Supplement)
Apple Cider Vinegar + Coconut Water
Patients will drink apple cider vinegar for 7 days. After a washout period of 2 weeks, patients will then drink coconut water for 7 days.
Intervention: Apple Cider Vinegar (Dietary Supplement)
Outcomes
Primary Outcomes
Apple Cider Vinegar Urinary Citrate Increase
Time Frame: 1 week
Determine the change in urinary citrate levels due to the addition of apple cider vinegar to the diet
Secondary Outcomes
- Apple Cider Vinegar and urinary pH(1 week)
- Palatability Evaluation(4 weeks)
- Apple Cider Vinegar Against Other Beverages(4 weeks)
Investigators
Christine Herforth
Urology Resident
United States Naval Medical Center, San Diego