Gracie Diet for Gastroesophageal Reflux Disease

NCT ID: NCT04360252

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-13
• Study Completion Date: 2027-12-31

Brief Summary

The goal of this clinical trial is to learn if dietary changes can help improve gastroesophageal reflux disease (GERD) symptoms. The main question[s] it aims to answer whether the Gracie Diet is an option to treat GERD symptoms in individuals wish to discontinue standard doses of PPI and / or H2 receptor antagonists.

Participants will be taken off PPI and be placed on the Gracie Diet for 8 weeks. Information about the participants reflux symptoms and GERD health related quality of life will be collected to assess the effect of the diet.

Detailed Description

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.

Conditions

Gastroesophageal Reflux; GERD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gracie Diet

Patients will have a nutritional consultation and will follow the Gracie diet for a month.

Group Type: EXPERIMENTAL

Gracie Diet

Intervention Type: OTHER

The patient is going to have an encounter with the nutritionist (either face to face or by phone call) and she will provide patient with the requisite nutritional information and will guide patient on how to properly adhere to the diet.

The session is designed to: answer patient questions, educate patients so that patients understand the underlying nutritional concepts that the diet is based upon, support patients by empowering the patients to make healthy nutritional choices consistent with the diet, educate patients regarding the appropriate combinations of healthy foods, and help patients to develop menu samples based on the Gracie Diet when there is interest.

Interventions

Gracie Diet

The patient is going to have an encounter with the nutritionist (either face to face or by phone call) and she will provide patient with the requisite nutritional information and will guide patient on how to properly adhere to the diet.

The session is designed to: answer patient questions, educate patients so that patients understand the underlying nutritional concepts that the diet is based upon, support patients by empowering the patients to make healthy nutritional choices consistent with the diet, educate patients regarding the appropriate combinations of healthy foods, and help patients to develop menu samples based on the Gracie Diet when there is interest.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Bulat, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00248899

Identifier Type: -

Identifier Source: org_study_id