The Effect of Apple Cider Vinegar Supplementation on 24-hour Urine Chemistry in Adults
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Luke Reynolds
- Phone Number: 7137926105
- Email: lukereynolds@bsd.uchicago.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- The University of Chicago
-
Contact:
- Luke Reynolds
- Phone Number: 713-792-6105
- Email: lukereynolds@bsd.uchicago.edu
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Controls: Adults above the age of 18.
- Kidney stone patients: Adults above the age of 18.
- History of majority (>50%) calcium oxalate kidney stones
Exclusion Criteria:
- Anyone with a history of calcium phosphate stones (>50% calcium phosphate), uric acid stones, struvite stones, recent urinary tract instrumentation (<30 days), or recurrent urinary tract infections.
- Any individual who has had ACV outside of normal consumption in the prior month will be excluded.
- Any individual who has a history of a negative reaction (increased acid reflux, allergy) to ACV will also be excluded.
- Any individual with chronic kidney disease, underlying acid base disorder will also be excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: kidney stone patients and healthy participants
Each participant will be asked to complete a basic metabolic panel prior to initiating the study to ensure that no baseline metabolic derangements exist.
On day 1, participants will complete a 24-hour urine collection and 48-hour food diary at home.
Participants will then consume an ACV gummy containing 60 meq daily for 14 consecutive days.
|
Goli Apple Cider Vinegar gummies
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measure changes in citrate in urine.
Time Frame: From Enrollment to 2 weeks
|
to evaluate the effect of short-term daily apple cider vinegar (ACV) supplementation on urine chemistry.
|
From Enrollment to 2 weeks
|
|
Measure changes in Urine PH
Time Frame: From enrollment to 2 weeks
|
to evaluate the effect of short-term daily apple cider vinegar (ACV) supplementation on urine chemistry.
|
From enrollment to 2 weeks
|
|
Measure changes in calcium in urine.
Time Frame: from enrollment to 2 weeks
|
to evaluate the effect of short-term daily apple cider vinegar (ACV) supplementation on urine chemistry.
|
from enrollment to 2 weeks
|
|
Measure changes in calcium oxalate in urine
Time Frame: From Enrollment to 2 weeks
|
to evaluate the effect of short-term daily apple cider vinegar (ACV) supplementation on urine chemistry.
|
From Enrollment to 2 weeks
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Luke Reynolds, The University of Chicago Medical Center
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Male Urogenital Diseases
- Calculi
- Pathological Conditions, Anatomical
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urolithiasis
- Urinary Calculi
- Nephrolithiasis
- Pathological Conditions, Signs and Symptoms
- Kidney Calculi
Other Study ID Numbers
Other Study ID Numbers
- IRB25-0715
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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