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

Naval Medical Center

Status: Unknown

Conditions: Kidney Stones, Urolithiasis, Hypocitraturia

Treatments: Dietary Supplement: Apple Cider Vinegar; Dietary Supplement: Other Beverage

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04073719

NMCSD.2019.0026

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 12 patient groups

Apple Cider Vinegar + Coconut Water

Experimental group

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.

Treatment:

Dietary Supplement: Apple Cider Vinegar

Apple Cider Vinegar + Citric Soda

Experimental group

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.

Treatment:

Dietary Supplement: Apple Cider Vinegar

Apple Cider Vinegar + Lemonade

Experimental group

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.

Treatment:

Dietary Supplement: Apple Cider Vinegar

Coconut Water + Apple Cider Vinegar

Experimental group

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.

Treatment:

Dietary Supplement: Apple Cider Vinegar

Coconut Water + Citric Soda

Experimental group

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.

Treatment:

Dietary Supplement: Other Beverage

Coconut Water + Lemonade

Experimental group

Description:

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

Treatment:

Dietary Supplement: Other Beverage

Citric Soda + Apple Cider Vinegar

Experimental group

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.

Treatment:

Dietary Supplement: Other Beverage

Dietary Supplement: Apple Cider Vinegar

Citric Soda + Coconut Water

Experimental group

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.

Treatment:

Dietary Supplement: Other Beverage

Citric Soda + Lemonade

Experimental group

Description:

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

Treatment:

Dietary Supplement: Other Beverage

Lemonade + Apple Cider Vinegar

Experimental group

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.

Treatment:

Dietary Supplement: Apple Cider Vinegar

Lemonade + Coconut Water

Experimental group

Description:

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

Treatment:

Dietary Supplement: Other Beverage

Lemonade + Citric Soda

Experimental group

Description:

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

Treatment:

Dietary Supplement: Other Beverage