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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Carol Johnston, PhD
- Telefonnummer: 6024963463
- E-post: carol.johnston@asu.edu
Studiesteder
-
-
Arizona
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Phoenix, Arizona, Forente stater, 85004
- Rekruttering
- Arizona Biomedical Collaborative
-
Ta kontakt med:
- Carol Johnston, PhD
- Telefonnummer: 6024962539
- E-post: carol.johnston@asu.edu
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Vinegar drink
2 tablespoons apple cider vinegar |
2 Tablespoons |
|
Placebo komparator: Placebo
Vinegar tablet |
Tablet |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
heartburn symptoms
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STUDY00025091
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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