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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Carol Johnston, PhD
- Numéro de téléphone: 6024963463
- E-mail: carol.johnston@asu.edu
Lieux d'étude
-
-
Arizona
-
Phoenix, Arizona, États-Unis, 85004
- Recrutement
- Arizona Biomedical Collaborative
-
Contact:
- Carol Johnston, PhD
- Numéro de téléphone: 6024962539
- E-mail: carol.johnston@asu.edu
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Vinegar drink
2 tablespoons apple cider vinegar |
2 Tablespoons |
|
Comparateur placebo: Placebo
Vinegar tablet |
Tablet |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
heartburn symptoms
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- STUDY00025091
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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