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

NCT ID: NCT04073719

Last Updated: 2019-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2022-05-31

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.

Conditions

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Kidney Stones, Urolithiasis, Hypocitraturia

Keywords

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Kidney Stones, Urolithiasis, Hypocitraturia, Apple Cider Vinegar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Prospective randomized sample of 36 patients, in a nested cross over design.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Apple Cider Vinegar

Intervention Type DIETARY_SUPPLEMENT

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.

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.

Group Type EXPERIMENTAL

Apple Cider Vinegar

Intervention Type DIETARY_SUPPLEMENT

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.

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.

Group Type EXPERIMENTAL

Apple Cider Vinegar

Intervention Type DIETARY_SUPPLEMENT

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.

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.

Group Type EXPERIMENTAL

Apple Cider Vinegar

Intervention Type DIETARY_SUPPLEMENT

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.

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.

Group Type EXPERIMENTAL

Other Beverage

Intervention Type DIETARY_SUPPLEMENT

To what degree do other high citrate beverages impact urinary citrate output.

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.

Group Type EXPERIMENTAL

Other Beverage

Intervention Type DIETARY_SUPPLEMENT

To what degree do other high citrate beverages impact urinary citrate output.

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.

Group Type EXPERIMENTAL

Apple Cider Vinegar

Intervention Type DIETARY_SUPPLEMENT

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.

Other Beverage

Intervention Type DIETARY_SUPPLEMENT

To what degree do other high citrate beverages impact urinary citrate output.

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.

Group Type EXPERIMENTAL

Other Beverage

Intervention Type DIETARY_SUPPLEMENT

To what degree do other high citrate beverages impact urinary citrate output.

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.

Group Type EXPERIMENTAL

Other Beverage

Intervention Type DIETARY_SUPPLEMENT

To what degree do other high citrate beverages impact urinary citrate output.

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.

Group Type EXPERIMENTAL

Apple Cider Vinegar

Intervention Type DIETARY_SUPPLEMENT

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.

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.

Group Type EXPERIMENTAL

Other Beverage

Intervention Type DIETARY_SUPPLEMENT

To what degree do other high citrate beverages impact urinary citrate output.

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.

Group Type EXPERIMENTAL

Other Beverage

Intervention Type DIETARY_SUPPLEMENT

To what degree do other high citrate beverages impact urinary citrate output.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Other Beverage

To what degree do other high citrate beverages impact urinary citrate output.

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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United States Naval Medical Center, San Diego

FED

Sponsor Role lead

Responsible Party

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Christine Herforth

Urology Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Christine M Herfroth, MD

Role: CONTACT

Phone: 6195327227

Email: [email protected]

Jesse E Resovsky, BS

Role: CONTACT

Phone: 6195327226

Email: [email protected]

References

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Other Identifiers

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NMCSD.2019.0026

Identifier Type: -

Identifier Source: org_study_id