Vinegar and Heartburn
Examining the Efficacy of Vinegar for Reducing Heartburn Symptoms Related to Gastroesophageal Reflux Disease (GERD)
In this study, a popular home remedy, vinegar, will be tested for its efficacy to relieve the discomfort of heartburn possibly by inducing the esophageal clearing mechanisms. We plan to recruit 22 individuals who report regular heartburn, but not diagnosed with erosive reflux disease, for this randomized crossover trial. Enrolled participants will identify foods that consistently cause their heartburn, and two of these foods will be prepared and consumed during their visits. Participants will arrive at the testing center on two occasions following a 4-h fast (no food or beverage except water) and consume the targeted foods in a 10-minute period. On one visit liquid vinegar will be ingested with the meal, and on the other visit (order of visits will be randomly determined) a vinegar tablet (control) will be ingested with the meal. Starting prior to food ingestion and for 2 hours post meal, symptoms will be assessed at 10-to-15-minute intervals by the participant using a validated heartburn severity scale.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Currently a great deal of research is focused on relationships between GERD, esophageal pH, esophageal clearing-content mechanisms, and the functioning of the esophageal sphincter (LES). Transient LES relaxation may also contribute to GERD. In the esophagus, both chemical and physical reactions are used to clear content from the stomach due to reflux. Saliva flow is increased when the body senses acid because saliva acts as a buffer, which neutralizes the acid through chemical reactions. The physical process of clearing acidic content occurs via esophageal emptying by peristalsis. Several studies show that, in the esophageal mucosa, there are acid sensitive receptors that sense the change in intraluminal pH and induce esophageal peristaltic contractions that are independent of swallowing. The movement of this acid-induced contraction is long in duration, high in amplitude, and low in propagation velocity. As the first randomized controlled trial examining the effect of vinegar ingestion on heartburn, this study will examine symptoms of heartburn only and not focus on mechanisms.
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Carol Johnston, PhD
- Phone Number: 6024963463
- Email: carol.johnston@asu.edu
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85004
- Recruiting
- Arizona Biomedical Collaborative
-
Contact:
- Carol Johnston, PhD
- Phone Number: 6024962539
- Email: carol.johnston@asu.edu
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- report heartburn symptoms two or more times a week for several weeks or months
- Any over the counter PPI use (proton-pump inhibitors such as Prilosec, Nexium, Prevacid) will need to be restricted for one month.
Exclusion Criteria:
- Drug use (prescription, over-the-counter, or otherwise) known to affect the stomach and digestive processes, including GLP-1 RA or GLP/GIP medications
- Medical conditions that impact normal functioning of the gastrointestinal tract (e.g., Crohn's disease, Celiac disease, short bowel syndrome, ostomy, lactose intolerance, hernia , SIBO, H. Pylori positive hasn't been cleared etc.).
- Excess alcohol use (>2 servings daily)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Vinegar drink
2 tablespoons apple cider vinegar |
2 Tablespoons |
|
Placebo Comparator: Placebo
Vinegar tablet |
Tablet |
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
heartburn symptoms
Time Frame: measured premeal and at 15 to 30 minute intervals during the 2-h postprandial period
|
validated Likert scale questionnaires |
measured premeal and at 15 to 30 minute intervals during the 2-h postprandial period
|
Collaborators and Investigators
Sponsor
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- STUDY00025091
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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