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

Primary Purpose

Kidney Stones, Urolithiasis, Hypocitraturia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Apple Cider Vinegar
Other Beverage
Sponsored by
United States Naval Medical Center, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Kidney Stones, Urolithiasis, Hypocitraturia focused on measuring Kidney Stones, Urolithiasis, Hypocitraturia, Apple Cider Vinegar

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm 9

    Arm 10

    Arm 11

    Arm 12

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Apple Cider Vinegar + Coconut Water

    Apple Cider Vinegar + Citric Soda

    Apple Cider Vinegar + Lemonade

    Coconut Water + Apple Cider Vinegar

    Coconut Water + Citric Soda

    Coconut Water + Lemonade

    Citric Soda + Apple Cider Vinegar

    Citric Soda + Coconut Water

    Citric Soda + Lemonade

    Lemonade + Apple Cider Vinegar

    Lemonade + Coconut Water

    Lemonade + Citric Soda

    Arm Description

    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.

    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.

    Patients will drink apple cider vinegar for 7 days. After a washout period of 2 weeks, patients will then drink lemonade for 7 days.

    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.

    Patients will drink coconut water for 7 days. After a washout period of 2 weeks, patients will then drink citric soda for 7 days.

    Patients will drink coconut water for 7 days. After a washout period of 2 weeks, patients will then drink lemonade for 7 days.

    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.

    Patients will drink citric soda for 7 days. After a washout period of 2 weeks, patients will then drink coconut water for 7 days.

    Patients will drink citric soda for 7 days. After a washout period of 2 weeks, patients will then drink lemonade for 7 days.

    Patients will drink lemonade for 7 days. After a washout period of 2 weeks, patients will then drink apple cider vinegar for 7 days.

    Patients will drink lemonade for 7 days. After a washout period of 2 weeks, patients will then drink coconut water for 7 days.

    Patients will drink lemonade for 7 days. After a washout period of 2 weeks, patients will then drink citric soda for 7 days.

    Outcomes

    Primary Outcome Measures

    Apple Cider Vinegar Urinary Citrate Increase
    Determine the change in urinary citrate levels due to the addition of apple cider vinegar to the diet

    Secondary Outcome Measures

    Apple Cider Vinegar and urinary pH
    Determine the effect of apple cider vinegar on urinary pH
    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)
    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.

    Full Information

    First Posted
    August 28, 2019
    Last Updated
    August 28, 2019
    Sponsor
    United States Naval Medical Center, San Diego
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04073719
    Brief Title
    Apple Cider Vinegar for the Prevention of Urinary Lithiasis (APUL)
    Acronym
    APUL
    Official Title
    Apple Cider Vinegar for the Prevention of Urinary Lithiasis (APUL)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2019 (Anticipated)
    Primary Completion Date
    May 31, 2021 (Anticipated)
    Study Completion Date
    May 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    United States Naval Medical Center, San Diego

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Kidney Stones, Urolithiasis, Hypocitraturia
    Keywords
    Kidney Stones, Urolithiasis, Hypocitraturia, Apple Cider Vinegar

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    Prospective randomized sample of 36 patients, in a nested cross over design.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Apple Cider Vinegar + Coconut Water
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Apple Cider Vinegar + Citric Soda
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Apple Cider Vinegar + Lemonade
    Arm Type
    Experimental
    Arm Description
    Patients will drink apple cider vinegar for 7 days. After a washout period of 2 weeks, patients will then drink lemonade for 7 days.
    Arm Title
    Coconut Water + Apple Cider Vinegar
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Coconut Water + Citric Soda
    Arm Type
    Experimental
    Arm Description
    Patients will drink coconut water for 7 days. After a washout period of 2 weeks, patients will then drink citric soda for 7 days.
    Arm Title
    Coconut Water + Lemonade
    Arm Type
    Experimental
    Arm Description
    Patients will drink coconut water for 7 days. After a washout period of 2 weeks, patients will then drink lemonade for 7 days.
    Arm Title
    Citric Soda + Apple Cider Vinegar
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Citric Soda + Coconut Water
    Arm Type
    Experimental
    Arm Description
    Patients will drink citric soda for 7 days. After a washout period of 2 weeks, patients will then drink coconut water for 7 days.
    Arm Title
    Citric Soda + Lemonade
    Arm Type
    Experimental
    Arm Description
    Patients will drink citric soda for 7 days. After a washout period of 2 weeks, patients will then drink lemonade for 7 days.
    Arm Title
    Lemonade + Apple Cider Vinegar
    Arm Type
    Experimental
    Arm Description
    Patients will drink lemonade for 7 days. After a washout period of 2 weeks, patients will then drink apple cider vinegar for 7 days.
    Arm Title
    Lemonade + Coconut Water
    Arm Type
    Experimental
    Arm Description
    Patients will drink lemonade for 7 days. After a washout period of 2 weeks, patients will then drink coconut water for 7 days.
    Arm Title
    Lemonade + Citric Soda
    Arm Type
    Experimental
    Arm Description
    Patients will drink lemonade for 7 days. After a washout period of 2 weeks, patients will then drink citric soda for 7 days.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Apple Cider Vinegar
    Intervention Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Other Beverage
    Intervention Description
    To what degree do other high citrate beverages impact urinary citrate output.
    Primary Outcome Measure Information:
    Title
    Apple Cider Vinegar Urinary Citrate Increase
    Description
    Determine the change in urinary citrate levels due to the addition of apple cider vinegar to the diet
    Time Frame
    1 week
    Secondary Outcome Measure Information:
    Title
    Apple Cider Vinegar and urinary pH
    Description
    Determine the effect of apple cider vinegar on urinary pH
    Time Frame
    1 week
    Title
    Apple Cider Vinegar Against Other Beverages
    Description
    Compare the effect of apple cider vinegar on urinary citrate with that of known citrate-rich beverages (lemonade, citrus based soda, coconut water)
    Time Frame
    4 weeks
    Title
    Palatability Evaluation
    Description
    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.
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Christine M Herfroth, MD
    Phone
    6195327227
    Email
    christine.m.herforth.mil@mail.mil
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jesse E Resovsky, BS
    Phone
    6195327226
    Email
    jreso001@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Apple Cider Vinegar for the Prevention of Urinary Lithiasis (APUL)

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