Gracie Diet for Acid Reflux

Overseen by Robert Bulat, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Johns Hopkins University

Must be taking: PPI, H2 blockers

Disqualifiers: Pregnancy, Barrett's esophagus, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial is testing the Gracie Diet, which involves specific food combinations and meal spacing, to help people with GERD who don't get better with usual medications. The diet aims to improve digestion and reduce symptoms by preventing bad chemical reactions in the stomach.

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 data supports the effectiveness of the Gracie Diet treatment for acid reflux?

There is evidence that certain dietary changes, like reducing high-fat foods and quick-release sugars, can help manage acid reflux symptoms. Additionally, a study showed that sugarcane flour, which may be similar to components of the Gracie Diet, significantly reduced symptoms of acid reflux. ^{1 2 3 4 5}

Is the Gracie Diet safe for humans?

There is no specific safety data available for the Gracie Diet itself, but general safety evaluations of dietary supplements and food ingredients suggest that they are generally safe when used as intended. However, interactions with medications and individual sensitivities should be considered. ^{6 7 8 9 10}

How does the Gracie Diet treatment for acid reflux differ from other treatments?

The Gracie Diet is unique because it focuses on specific food combinations and meal timing to manage acid reflux, unlike other treatments that may rely on medications to reduce stomach acid. This diet emphasizes avoiding high-fat, spicy, and acidic foods, which are known to trigger reflux symptoms, and promotes a balanced intake of proteins and carbohydrates. ^{3 4 5 11 12}

Research Team

Robert Bulat, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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 am 18 years old or older.

Exclusion Criteria

Pregnancy or nursing

I have had surgery on my upper stomach area before.

My symptoms are not due to GI obstruction, Barrett's esophagus, or esophageal cancer.

Trial Timeline

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)

Treatment Details

Interventions

• Gracie Diet (Behavioural Intervention)

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.

Participant Groups

Group I: Gracie Diet Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Theodore DeWeese

Johns Hopkins University

Chief Executive Officer since 2023

MD from an unspecified institution

Allen Kachalia

Johns Hopkins University

Chief Medical Officer since 2023

MD from an unspecified institution

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

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]

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 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]

References

1. United States 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Are lifestyle measures effective in patients with gastroesophageal reflux disease? An evidence-based approach. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Is Diet Sufficient as Laryngopharyngeal Reflux Treatment? A Cross-Over Observational Study. [2022]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Dietary Intake in Relation to the Risk of Reflux Disease: A Systematic Review. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Anti-Heartburn Effects of Sugar Cane Flour: A Double-Blind, Randomized, Placebo-Controlled Study. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

The state of adverse event reporting and signal generation of dietary supplements in Korea. [2010]

7. Japan 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]. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

GRASr2 evaluation of aliphatic acyclic and alicyclic terpenoid tertiary alcohols and structurally related substances used as flavoring ingredients. [2018]

9. Netherlands pubmed.ncbi.nlm.nih.gov

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

10. France pubmed.ncbi.nlm.nih.gov

[Post-marketing safety profile of avocado-soybean unsaponifiables]. [2023]

11. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Food and Gastroesophageal Reflux Disease. [2022]

12. Iran pubmed.ncbi.nlm.nih.gov

Total diet, individual meals, and their association with gastroesophageal reflux disease. [2022]