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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Carol Johnston, PhD
- Telefoonnummer: 6024963463
- E-mail: carol.johnston@asu.edu
Studie Locaties
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Arizona
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Phoenix, Arizona, Verenigde Staten, 85004
- Werving
- Arizona Biomedical Collaborative
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Contact:
- Carol Johnston, PhD
- Telefoonnummer: 6024962539
- E-mail: carol.johnston@asu.edu
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Vinegar drink
2 tablespoons apple cider vinegar |
2 Tablespoons |
|
Placebo-vergelijker: Placebo
Vinegar tablet |
Tablet |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
heartburn symptoms
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- STUDY00025091
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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