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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04073719
Recruitment Status : Unknown
Verified August 2019 by Christine Herforth, United States Naval Medical Center, San Diego.
Recruitment status was:  Not yet recruiting
First Posted : August 29, 2019
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
Christine Herforth, United States Naval Medical Center, San Diego

Study Description
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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.

Condition or disease Intervention/treatment Phase
Kidney Stones, Urolithiasis, Hypocitraturia Dietary Supplement: Apple Cider Vinegar Dietary Supplement: Other Beverage Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Prospective randomized sample of 36 patients, in a nested cross over design.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Apple Cider Vinegar for the Prevention of Urinary Lithiasis (APUL)
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Dietary Supplement: Apple Cider Vinegar
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.
Experimental: 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.
 Dietary Supplement: Apple Cider Vinegar
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.
Experimental: 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.
 Dietary Supplement: Apple Cider Vinegar
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.
Experimental: 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.
 Dietary Supplement: Apple Cider Vinegar
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.
Experimental: 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.
 Dietary Supplement: Other Beverage
To what degree do other high citrate beverages impact urinary citrate output.
Experimental: 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.
 Dietary Supplement: Other Beverage
To what degree do other high citrate beverages impact urinary citrate output.
Experimental: 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.
 Dietary Supplement: Apple Cider Vinegar
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.

Dietary Supplement: Other Beverage
To what degree do other high citrate beverages impact urinary citrate output.
Experimental: 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.
 Dietary Supplement: Other Beverage
To what degree do other high citrate beverages impact urinary citrate output.
Experimental: 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.
 Dietary Supplement: Other Beverage
To what degree do other high citrate beverages impact urinary citrate output.
Experimental: 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.
 Dietary Supplement: Apple Cider Vinegar
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.
Experimental: 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.
 Dietary Supplement: Other Beverage
To what degree do other high citrate beverages impact urinary citrate output.
Experimental: 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.
 Dietary Supplement: Other Beverage
To what degree do other high citrate beverages impact urinary citrate output.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Apple Cider Vinegar and urinary pH [ Time Frame: 1 week ]
    Determine the effect of apple cider vinegar on urinary pH

  2. Apple Cider Vinegar Against Other Beverages [ Time Frame: 4 weeks ]
    Compare the effect of apple cider vinegar on urinary citrate with that of known citrate-rich beverages (lemonade, citrus based soda, coconut water)

  3. Palatability Evaluation [ Time Frame: 4 weeks ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04073719


Contacts
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Contact: Christine M Herfroth, MD 6195327227 christine.m.herforth.mil@mail.mil
Contact: Jesse E Resovsky, BS 6195327226 jreso001@gmail.com

Sponsors and Collaborators
United States Naval Medical Center, San Diego
More Information
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Publications:

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Responsible Party: Christine Herforth, Urology Resident, United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier: NCT04073719    
Other Study ID Numbers: NMCSD.2019.0026
First Posted: August 29, 2019    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christine Herforth, United States Naval Medical Center, San Diego:
Kidney Stones, Urolithiasis, Hypocitraturia, Apple Cider Vinegar
Additional relevant MeSH terms:
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Kidney Calculi
Nephrolithiasis
Urolithiasis
Urinary Calculi
Lithiasis
Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Male Urogenital Diseases
Calculi
Pathological Conditions, Anatomical
Pathologic Processes
Acetic Acid
Anti-Bacterial Agents
Anti-Infective Agents