Apple Cider Vinegar for the Prevention of Urinary Lithiasis (APUL)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Apple Cider Vinegar for the Prevention of Urinary Lithiasis (APUL)

Conditions
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Kidney Stones, Urolithiasis, Hypocitraturia

Intervention / Treatment
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* Dietary Supplement: Apple Cider Vinegar
* Dietary Supplement: Other Beverage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Prospective randomized sample of 36 patients, in a nested cross over design.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apple Cider Vinegar + Coconut Water<br>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. | Dietary Supplement: Apple Cider Vinegar<br>* Will drinking apple cider vinegar increase urinary citrate levels to a greater degree than other beverages and which beverages produce the most significant effects compared against one another.<br>|
| Experimental: Apple Cider Vinegar + Citric Soda<br>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. | Dietary Supplement: Apple Cider Vinegar<br>* Will drinking apple cider vinegar increase urinary citrate levels to a greater degree than other beverages and which beverages produce the most significant effects compared against one another.<br>|
| Experimental: Apple Cider Vinegar + Lemonade<br>Patients will drink apple cider vinegar for 7 days. After a washout period of 2 weeks, patients will then drink lemonade for 7 days. | Dietary Supplement: Apple Cider Vinegar<br>* Will drinking apple cider vinegar increase urinary citrate levels to a greater degree than other beverages and which beverages produce the most significant effects compared against one another.<br>|
| Experimental: Coconut Water + Apple Cider Vinegar<br>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. | Dietary Supplement: Apple Cider Vinegar<br>* Will drinking apple cider vinegar increase urinary citrate levels to a greater degree than other beverages and which beverages produce the most significant effects compared against one another.<br>|
| Experimental: Coconut Water + Citric Soda<br>Patients will drink coconut water for 7 days. After a washout period of 2 weeks, patients will then drink citric soda for 7 days. | Dietary Supplement: Other Beverage<br>* To what degree do other high citrate beverages impact urinary citrate output.<br>|
| Experimental: Coconut Water + Lemonade<br>Patients will drink coconut water for 7 days. After a washout period of 2 weeks, patients will then drink lemonade for 7 days. | Dietary Supplement: Other Beverage<br>* To what degree do other high citrate beverages impact urinary citrate output.<br>|
| Experimental: Citric Soda + Apple Cider Vinegar<br>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. | Dietary Supplement: Apple Cider Vinegar<br>* Will drinking apple cider vinegar increase urinary citrate levels to a greater degree than other beverages and which beverages produce the most significant effects compared against one another.<br>Dietary Supplement: Other Beverage<br>* To what degree do other high citrate beverages impact urinary citrate output.<br>|
| Experimental: Citric Soda + Coconut Water<br>Patients will drink citric soda for 7 days. After a washout period of 2 weeks, patients will then drink coconut water for 7 days. | Dietary Supplement: Other Beverage<br>* To what degree do other high citrate beverages impact urinary citrate output.<br>|
| Experimental: Citric Soda + Lemonade<br>Patients will drink citric soda for 7 days. After a washout period of 2 weeks, patients will then drink lemonade for 7 days. | Dietary Supplement: Other Beverage<br>* To what degree do other high citrate beverages impact urinary citrate output.<br>|
| Experimental: Lemonade + Apple Cider Vinegar<br>Patients will drink lemonade for 7 days. After a washout period of 2 weeks, patients will then drink apple cider vinegar for 7 days. | Dietary Supplement: Apple Cider Vinegar<br>* Will drinking apple cider vinegar increase urinary citrate levels to a greater degree than other beverages and which beverages produce the most significant effects compared against one another.<br>|
| Experimental: Lemonade + Coconut Water<br>Patients will drink lemonade for 7 days. After a washout period of 2 weeks, patients will then drink coconut water for 7 days. | Dietary Supplement: Other Beverage<br>* To what degree do other high citrate beverages impact urinary citrate output.<br>|
| Experimental: Lemonade + Citric Soda<br>Patients will drink lemonade for 7 days. After a washout period of 2 weeks, patients will then drink citric soda for 7 days. | Dietary Supplement: Other Beverage<br>* To what degree do other high citrate beverages impact urinary citrate output.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apple Cider Vinegar Urinary Citrate Increase | Determine the change in urinary citrate levels due to the addition of apple cider vinegar to the diet | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apple Cider Vinegar and urinary pH | Determine the effect of apple cider vinegar on urinary pH | 1 week | 
| Apple Cider Vinegar Against Other Beverages | Compare the effect of apple cider vinegar on urinary citrate with that of known citrate-rich beverages (lemonade, citrus based soda, coconut water) | 4 weeks | 
| Palatability Evaluation | Compare the palatability of apple cider vinegar and other known citrate-rich beverages (lemonade, citrus based soda, coconut water). Patients will keep daily log whwere they can free write any side effects (from palatability perspective and otherwise). At the end of the study a 2 question survery (Likert scale format) will be filled in which participants will answer the liklihood of their willingness to consume the beverage daily for the prevention of kidney stones. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney Stones, Urolithiasis, Hypocitraturia, Apple Cider Vinegar