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

August 28, 2019 updated by: Christine Herforth, United States Naval Medical Center, San Diego
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apple Cider Vinegar and urinary pH
Time Frame: 1 week
Determine the effect of apple cider vinegar on urinary pH
1 week
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)
4 weeks
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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United States Naval Medical Center, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2019

Primary Completion (Anticipated)

May 31, 2021

Study Completion (Anticipated)

May 31, 2022

Study Registration Dates

First Submitted

August 28, 2019

First Submitted That Met QC Criteria

August 28, 2019

First Posted (Actual)

August 29, 2019

Study Record Updates

Last Update Posted (Actual)

August 30, 2019

Last Update Submitted That Met QC Criteria

August 28, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMCSD.2019.0026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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