Gracie Diet for Gastroesophageal Reflux Disease

  • STATUS
    Recruiting
  • End date
    Dec 1, 2023
  • participants needed
    20
  • sponsor
    Johns Hopkins University
Updated on 20 November 2021

Summary

GERD, is a common and chronic world-wide disease. Cardinal symptoms of this condition are heartburn-regurgitation, and sometimes with extra-intestinal symptoms that can affect patients' quality of life. Proton pump inhibitors (PPIs) potently inhibit gastric acid secretion and are widely used for treatment of acid-related diseases. This class of medications is the most widely used for the management of GERD. H2 Receptor Antagonists (H2RAs) are another type of medication used to of uncomplicated GERD, gastric or duodenal ulcers, gastric hypersecretion, and for mild to infrequent heartburn or indigestion. H2RAs decrease gastric acid secretion by reversibly binding to histamine H2 receptors located on gastric parietal cells, thereby inhibiting the binding and action of the endogenous ligand histamine.

Dietary modification is endorsed by the National Institutes of Health and the American College of Gastroenterology as a first-line therapy for patients with GERD. The Gracie Diet is thought to play an important role in the prevention of GERD. The concept behind this diet is that the consumption of proper food combinations promotes optimal health by preventing unhealthy chemical reactions in the digestive process such as fermentation and acidity.

This diet describes the benefits of combining different foods together and the downsides of combining others. It provides guidance on avoiding specific foods and combinations of foods that may aggravate GERD, and adopting meal spacing habits to improve overall health outcomes. The idea is that such dietary changes support more efficient digestion and encourage healthier lifestyles (i.e. smoking cessation, elimination of alcohol intake, avoidance of soda consumption and desserts). This diet also supports the acquisition of healthy eating habits characterized by higher consumption of fruits, vegetables, and whole grains, and encourages a reduction in the intake of saturated fat, sodium, added sugars, and canned foods. Limiting beverage consumption of water or fresh coconut water between meals is also encouraged. In this pilot study, the investigators hypothesized that the Gracie diet it could be an alternative option to improve GERD symptoms in those patients who do not respond to standard doses of PPI and/or H2 receptor antagonists.

Details
Condition Gastroesophageal Reflux Disease (GERD), gastro-oesophageal reflux, Gastroesophageal Reflux, gastroesophageal reflux disease, gastric reflux, esophageal reflux, gerd
Treatment Gracie Diet
Clinical Study IdentifierNCT04360252
SponsorJohns Hopkins University
Last Modified on20 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years or older at registration
Patients with ongoing symptoms of GERD: heartburn (pyrosis) mid-sternal chest pain, regurgitation of fluid or food, development of esophageal inflammation that may lead to swallowing dysfunction, or extraesophageal manifestations (i.e. cough, bronchospasms, and hoarseness)
Use of one of the following PPI medications: omeprazole, lansoprazole, pantoprazole, rabeprazole, esomeprazole or dexlansoprazole. And/or use of one of the following H2 blockers medications as well: famotidine, cimetidine, ranitidine or nizatidine
Willing to comply with the Gracie diet regimen

Exclusion Criteria

Age < than 18 years
Patients unable to speak English
Pregnancy or nursing
Complicated oropharyngeal dysphagia or other condition with risk for aspiration from oral ingestion
Exclusion of other causes of symptoms as mechanical gastrointestinal obstruction, Barrett's esophagus and cancer of the esophagus by standard radiographic or endoscopic test evidenced in the medical record chart
A prior surgery of the upper gastrointestinal tract
Failure to give informed consent
Any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study
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