Gracie Diet for Acid Reflux

Overseen By Pankaj Pasricha, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must be taking: PPI, H2 blockers

Disqualifiers: Pregnancy, Barrett's esophagus, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether dietary changes can improve symptoms of gastroesophageal reflux disease (GERD), which includes heartburn and chest pain. Participants will stop using certain acid-reducing medications and follow the Gracie Diet for eight weeks. The trial will collect data on how these dietary changes affect symptoms and overall quality of life related to GERD. Individuals with ongoing GERD symptoms who currently use medications like omeprazole or famotidine and are open to trying a new diet might be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore innovative dietary approaches to managing GERD symptoms.

Will I have to stop taking my current medications?

Yes, participants will need to stop taking their current PPI (proton pump inhibitor) or H2 receptor antagonist medications and follow the Gracie Diet for 8 weeks.

What prior data suggests that the Gracie Diet is safe for treating GERD symptoms?

Research shows that specific safety information for the Gracie Diet is not available. However, as a diet plan, it primarily involves consuming certain foods rather than medications, suggesting it is likely safe for most people.

Studies on similar diets, such as low-carb diets, have shown they can improve symptoms of acid reflux (GERD) without causing harm. Another study found that high-fiber diets reduced reflux symptoms in patients. These findings suggest that dietary changes can be a safe way to manage GERD symptoms.

Consult a healthcare provider before starting a new diet, especially if there are health concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for acid reflux, which often involve medications like proton pump inhibitors or antacids, the Gracie Diet focuses on dietary changes to manage symptoms. Researchers are excited about this approach because it aims to address the root causes of acid reflux by optimizing digestion and food combinations, potentially reducing the need for medications. The Gracie Diet emphasizes natural food pairings and timing, which could offer a holistic and sustainable way to control acid reflux symptoms without the side effects associated with long-term medication use.

What evidence suggests that the Gracie Diet might be an effective treatment for GERD?

Research has shown that the Gracie Diet might help manage symptoms of gastroesophageal reflux disease (GERD). In one study with 98 veterans, reducing simple sugars in their diet significantly decreased acid reflux symptoms. Another review found that low-carbohydrate diets led to noticeable improvements in GERD. A different study examined how dietary changes affect esophageal acid and found that eating fewer carbs reduced reflux episodes. These findings suggest that the Gracie Diet, which involves dietary changes, could be a promising way to manage GERD symptoms without medication. Participants in this trial will follow the Gracie Diet to evaluate its effectiveness in managing GERD symptoms. ^{1 2 3 4 6}

Who Is on the Research Team?

Robert Bulat, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with ongoing GERD symptoms like heartburn and regurgitation, who are already taking PPIs or H2 blockers. It's not for those who can't speak English, have had upper GI surgery, are pregnant/nursing, or have other conditions that might affect their participation.

Inclusion Criteria

I am currently taking a PPI or H2 blocker medication.

Willing to comply with the Gracie diet regimen

I experience symptoms like heartburn, chest pain, or difficulty swallowing due to GERD.

Exclusion Criteria

Pregnancy or nursing

I have had surgery on my upper stomach area before.

Failure to give informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are taken off PPI and placed on the Gracie Diet for 8 weeks to assess its effect on GERD symptoms

8 weeks

Weekly check-ins (virtual or in-person)

Follow-up

Participants are monitored for changes in GERD symptoms and quality of life after the treatment phase

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Gracie Diet

Trial Overview The Gracie Diet is being tested as a potential alternative to improve GERD symptoms in patients unresponsive to standard doses of PPIs and/or H2 receptor antagonists. The diet focuses on food combinations to prevent digestive issues like fermentation and acidity.

How Is the Trial Designed?

Group I: Gracie Diet Experimental Treatment 1 Intervention

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

Gracie Diet is already approved in United States for the following indications:

Approved in United States as Gracie Diet for:

• Gastroesophageal Reflux Disease (GERD)

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Published Research Related to This Trial

The report from the Life Sciences Research Office's Select Committee emphasizes the need for improved safety evaluations of generally recognized as safe (GRAS) substances, based on a decade of experience in assessing food safety.

Key recommendations include phasing out the GRAS list, modifying the Delaney Clause, and enhancing testing protocols for human and animal studies to better understand the safety and potential health impacts of food ingredients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insights on food safety evaluation: a synopsis. Senti, FR.[2019]

The Korea Food & Drug Administration (KFDA) established an adverse event (AE) monitoring system for dietary supplements, collecting 1430 AE reports from 2006 to 2008, with 222 providing complete case details for analysis.

The monitoring identified a potential signal linking dietary fiber to vomiting, but due to insufficient data, the KFDA could not confirm a causal relationship, indicating the need for further investigation into this concern.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The state of adverse event reporting and signal generation of dietary supplements in Korea. Park, KS., Kwon, O.[2010]

A review of 117 adverse drug reactions (ADRs) related to avocado-soybean unsaponifiables (ASU) in France revealed that 35.9% of these reactions were serious, leading to hospitalization, but no deaths were reported.

The most common ADRs included skin reactions (32.5%), liver issues (16.2%), and gastrointestinal problems (12%), with symptoms often resolving quickly after stopping ASU, indicating a need for careful monitoring despite the low incidence of reported ADRs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Post-marketing safety profile of avocado-soybean unsaponifiables]. Olivier, P., Montastruc, JL.[2023]

A 9-week randomized controlled trial with 98 veterans showed that modifying carbohydrate intake, particularly reducing simple sugars, significantly decreased esophageal acid exposure time and the number of reflux episodes in patients with gastroesophageal reflux disease (GERD).

Participants reported improved symptoms, including reduced heartburn frequency and severity, indicating that dietary changes can be an effective strategy for managing GERD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Modifying Amount and Type of Dietary Carbohydrate on Esophageal Acid Exposure Time and Esophageal Reflux Symptoms: A Randomized Controlled Trial. Gu, C., Olszewski, T., King, KL., et al.[2023]

Weight loss and elevating the head of the bed are effective lifestyle modifications for managing gastroesophageal reflux disease (GERD), as they improve esophageal pH profiles and symptoms based on evidence from clinical trials.

There is no evidence that quitting tobacco or alcohol, or making dietary changes, leads to significant improvements in GERD symptoms or esophageal function, highlighting the limited efficacy of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are lifestyle measures effective in patients with gastroesophageal reflux disease? An evidence-based approach. Kaltenbach, T., Crockett, S., Gerson, LB.[2022]

This systematic review analyzed 25 studies on the impact of diet on gastroesophageal reflux disease (GERD), revealing that high-fat diets, carbonated beverages, citrus products, and spicy, salty, and fried foods are linked to an increased risk of GERD.

The review included various study types, such as case-control, cross-sectional, and prospective studies, highlighting the need for further research to clarify the dietary factors contributing to GERD risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Intake in Relation to the Risk of Reflux Disease: A Systematic Review. Heidarzadeh-Esfahani, N., Soleimani, D., Hajiahmadi, S., et al.[2022]

The Expert Panel of the Flavor and Extract Manufacturers Association has reaffirmed the Generally Recognized as Safe (GRAS) status of aliphatic acyclic and alicyclic terpenoid tertiary alcohols based on their safety evaluation, which included factors like metabolism and toxicology.

These flavor ingredients were found to be rapidly absorbed and excreted by humans and animals, with a significant margin of safety between estimated intake levels and no-observed-adverse effect levels, indicating they pose minimal health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GRASr2 evaluation of aliphatic acyclic and alicyclic terpenoid tertiary alcohols and structurally related substances used as flavoring ingredients. Marnett, LJ., Cohen, SM., Fukushima, S., et al.[2018]

A low-fat, low-quick-release sugar, high-protein, alkaline, and plant-based diet significantly improved symptoms in 74% of patients with laryngopharyngeal reflux (LPR) after 6 weeks, indicating its efficacy as a treatment option.

The study involved 50 patients and showed that symptom improvement continued for some patients up to 12 weeks, suggesting that dietary changes can be a cost-effective alternative therapy for LPR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is Diet Sufficient as Laryngopharyngeal Reflux Treatment? A Cross-Over Observational Study. Lechien, JR., Crevier-Buchman, L., Distinguin, L., et al.[2022]

A study analyzing 64 reports involving 71 patients found that liver dysfunction symptoms were primarily associated with the use of health foods alongside high-risk medications like antiepileptics and antineoplastics.

There is a lack of detailed information in journal articles regarding the specific ingredients of health foods, which complicates the understanding of potential interactions with conventional drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Notable Adverse Events Associated with Concomitant Use of Health Foods and Drugs Derived from the Analysis of HFNet Data on the Safety and Effectiveness of Health Foods]. Kojima, A., Sato, Y., Chiba, T., et al.[2019]

Gastroesophageal reflux disease (GERD) is linked to dietary factors, with certain foods like fatty foods, coffee, chocolate, and alcohol increasing reflux symptoms, while a Mediterranean diet and very low carbohydrate diet may help protect against it.

Timing of meals is crucial; having a short interval between eating and sleeping can worsen reflux, so it's recommended to have dinner at least four hours before bedtime.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food and Gastroesophageal Reflux Disease. Surdea-Blaga, T., Negrutiu, DE., Palage, M., et al.[2022]

In a pilot study involving 43 participants with medically-diagnosed GERD, prebiotic sugarcane flour significantly reduced symptoms like heartburn and regurgitation compared to a placebo after three weeks of treatment.

The study found that the intervention group experienced a mean decrease in heartburn symptoms by 2.2 points and total symptom scores by 3.7 points, indicating that sugarcane flour may be an effective dietary intervention for managing GERD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-Heartburn Effects of Sugar Cane Flour: A Double-Blind, Randomized, Placebo-Controlled Study. Beckett, JM., Singh, NK., Phillips, J., et al.[2021]

In a study of 217 subjects, those with gastroesophageal reflux disease (GERD) consumed significantly more fat and carbohydrates at lunch compared to controls, suggesting that high fat intake may worsen GERD symptoms.

Conversely, a higher percentage of energy from protein and greater protein intake at evening snacks were associated with a lower likelihood of GERD, indicating that dietary protein may help mitigate symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total diet, individual meals, and their association with gastroesophageal reflux disease. Ebrahimi-Mameghani, M., Sabour, S., Khoshbaten, M., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04360252?tab=history&a=3

Gracie Diet for Gastroesophageal Reflux Disease 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 ...

2. withpower.com withpower.com/trial/phase-esophagitis-peptic-10-2020-307eb

Gracie Diet for Acid Reflux A 9-week randomized controlled trial with 98 veterans showed that modifying carbohydrate intake, particularly reducing simple sugars, significantly decreased ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04360252/gracie-diet-for-gastroesophageal-reflux-disease

Gracie Diet for Gastroesophageal Reflux Disease The goal of this clinical trial is to learn if dietary changes can help improve gastroesophageal reflux disease (GERD) symptoms.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10857327/

A Systematic Review and Meta-Analysis of Intervention ... Low-carbohydrate diets showed a significant improvement in GERD-related outcomes, while a slow eating speed did not result in a reduction in reflux events.

5. journals.lww.com journals.lww.com/ajg/fulltext/2022/10000/the_effects_of_modifying_amount_and_type_of.24.aspx

The Effects of Modifying Amount and Type of Dietary... The primary outcomes were esophageal acid exposure time (AET) and total number of reflux episodes derived from 24-hour ambulatory pH monitoring. Secondary ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2772572323000961

Role of Nutrition in Gastroesophageal Reflux, Irritable ... In a study of 36 patients with nonerosive reflux disease, those consuming high-fiber diets had reduced reflux symptoms without an effect on objective measures ...