Gastroesophageal RefluxNCT04360252
Gracie Diet for Gastroesophageal Reflux Disease
A study testing Gracie Diet in people with Gastroesophageal Reflux and GERD, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastroesophageal Reflux, GERD
- What is being tested?
- Gracie Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2020to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
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.
Read the 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
- Being tested
- Gracie Diet
- Keywords
- GERD, Diet, Reflux
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gracie DietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Gracie Diet | Experimental | Patients will have a nutritional consultation and will follow the Gracie diet for a month. Receives: Other: Gracie Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in University of California Scleroderma Clinical Trial Consortium Gastrointestinal Tract (UCLA SCTC GIT 2.0) score
The effect of the Gracie Diet in GERD symptoms by changes in the UCLA SCTC GIT 2.0 score.
The UCLA-SCTC GIT 2.0 is a multi-item instrument that measures GI symptoms and the impact on health related quality of life. Includes 34 questions in 7 domains (reflux, distension, soilage, diarrhea, social function, emotional wellbeing and constipation) during a 7 day recall period. Each domain is weighted and scored, and a total score is then calculated.
Measured: Baseline, week 2 and week 4
Change in Patient Reported Outcomes Measurement Information System (PROMIS) scale score
The effect of the Gracie Diet in GERD symptoms by changes in the PROMIS Scale score. This questionnaire has items that measure the frequency, severity, impact, and bother of cardinal GERD symptoms, including heartburn and regurgitation, using a seven-day recall period. The questionnaire consists of 13 questions, and in each question, the answers are scored from 0 to 5.
Measured: Baseline, week 2 and week 4
Change in the Reflux Symptoms Index (RSI) score
The effect of the Gracie Diet in GERD symptoms by changes in the RSI score. The RSI is a nine-item questionnaire assessing symptom severity, and designed to assess the severity of symptoms related to laryngopharyngeal reflux. Normative data suggests that a RSI of greater than or equal to 13 is clinically significant. Therefore a RSI > 13 may be indicative of significant reflux disease.
Measured: Baseline, week 2 and week 4
Change in the Health-related Quality Of Life scale for GERD (GERD-HRQL) score
The effect of Gracie Diet in GERD symptoms by changes in the score of the GERD - HRQL. The GERD-HRQL was developed to survey symptomatic outcomes and therapeutic effects in patients with GERD. The scale has 11 items, which focus on heartburn symptoms, dysphagia, medication effects and the patient's present health condition. The GERD-HRQL takes approximately one minute to complete. Each item is scored from 0 to 5, with a higher score indicating a better QOL.
Measured: Baseline, week 2 and week 4
Change in the Gracie Diet adherence as assessed by a patient diary inventory
Assess adherence to diet through the use of a diary where the patient can track the food eaten during the day.
Measured: Daily up to 4 weeks
Change in GERD medication
The effect of Gracie Diet in medication intake through a review of the medication list, dose and intake frequency.
Measured: Baseline, week 2 and week 4
Secondary outcomes (1)
Change in Body Mass Index (BMI)
The effect of Gracie Diet in the BMI (kg/m^2). BMI is a person's weight in kilograms divided by the square of height in meters. The range values are Below 18.5 Underweight 18.5 - 24.9 Normal or Healthy Weight 25.0 - 29.9 Overweight 30.0 or higher Obese
Measured: Baseline, week 2 and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start13 Nov 2020
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Bulat, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360252
- Sponsor's protocol ID
- IRB00248899
- Status last verified
- Jan 2026
- First submitted
- 20 Apr 2020
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gracie Diet for Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT04360252
- Acronym / sponsor ID
- IRB00248899
- Conditions
- Gastroesophageal Reflux, GERD
- Keywords
- GERD, Diet, Reflux
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 13 Nov 2020 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gracie Diet | Experimental | Other: Gracie DietPatients will have a nutritional consultation and will follow the Gracie diet for a month. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gracie DietThe 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. | Other | Gracie Diet |
Primary outcome
Change in University of California Scleroderma Clinical Trial Consortium Gastrointestinal Tract (UCLA SCTC GIT 2.0) score
Time frame: Baseline, week 2 and week 4
The effect of the Gracie Diet in GERD symptoms by changes in the UCLA SCTC GIT 2.0 score. The UCLA-SCTC GIT 2.0 is a multi-item instrument that measures GI symptoms and the impact on health related quality of life. Includes 34 questions in 7 domains (reflux, distension, soilage, diarrhea, social function, emotional wellbeing and constipation) during a 7 day recall period. Each domain is weighted and scored, and a total score is then calculated.
Change in Patient Reported Outcomes Measurement Information System (PROMIS) scale score
Time frame: Baseline, week 2 and week 4
The effect of the Gracie Diet in GERD symptoms by changes in the PROMIS Scale score. This questionnaire has items that measure the frequency, severity, impact, and bother of cardinal GERD symptoms, including heartburn and regurgitation, using a seven-day recall period. The questionnaire consists of 13 questions, and in each question, the answers are scored from 0 to 5.
Change in the Reflux Symptoms Index (RSI) score
Time frame: Baseline, week 2 and week 4
The effect of the Gracie Diet in GERD symptoms by changes in the RSI score. The RSI is a nine-item questionnaire assessing symptom severity, and designed to assess the severity of symptoms related to laryngopharyngeal reflux. Normative data suggests that a RSI of greater than or equal to 13 is clinically significant. Therefore a RSI > 13 may be indicative of significant reflux disease.
Change in the Health-related Quality Of Life scale for GERD (GERD-HRQL) score
Time frame: Baseline, week 2 and week 4
The effect of Gracie Diet in GERD symptoms by changes in the score of the GERD - HRQL. The GERD-HRQL was developed to survey symptomatic outcomes and therapeutic effects in patients with GERD. The scale has 11 items, which focus on heartburn symptoms, dysphagia, medication effects and the patient's present health condition. The GERD-HRQL takes approximately one minute to complete. Each item is scored from 0 to 5, with a higher score indicating a better QOL.
Change in the Gracie Diet adherence as assessed by a patient diary inventory
Time frame: Daily up to 4 weeks
Assess adherence to diet through the use of a diary where the patient can track the food eaten during the day.
Change in GERD medication
Time frame: Baseline, week 2 and week 4
The effect of Gracie Diet in medication intake through a review of the medication list, dose and intake frequency.
1 secondary outcome
Change in Body Mass Index (BMI)
Time frame: Baseline, week 2 and week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Bulat, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gracie Diet in people with Gastroesophageal Reflux and GERD, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in University of California Scleroderma Clinical Trial Consortium Gastrointestinal Tract (UCLA SCTC GIT 2.0) score (time frame: Baseline, week 2 and week 4). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.