Study to Evaluate the Effect of a Very Low Carbohydrate Diet on Gastroesophageal Reflux Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to learn if a very low carbohydrate (sugar) diet or traditional low fat diet is able to reduce symptoms related to gastroesophageal reflux disease (GERD) in people who are overweight. Patients with GERD may experience all or some of the following symptoms: stomach acid or partially digested food re-entering the esophagus (which is sometimes referred to as heartburn or regurgitation) and belching. In this study, the investigators also hope to find out if acid in the esophagus is reduced more by a low carbohydrate diet than a low fat diet.

Official Title
-----------------
A Randomized, Double-Blind Crossover Study to Evaluate the Effect of a Very Low Carbohydrate Diet on Gastroesophageal Reflux Disease

Conditions
-----------------
Gastroesophageal Reflux Disease, Overweight, Acid Reflux Disease

Intervention / Treatment
-----------------
* Other: Diet - very low carb or low fat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 70 years old BMI between 30 kg/m2 and 45 kg/m2 Exclusion Criteria: Known history of Barrett's esophagus or esophageal adenocarcinoma Previous surgical anti-reflux procedure Previous weight loss surgery, including gastric bypass Diabetes Pregnancy Heart Disease Unwillingness to discontinue use of proton pump inhibitors (PPI's) or H2-receptor antagonists per study protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Very Low Carbohydrate Diet<br>Very Low Carbohydrate Diet | Other: Diet - very low carb or low fat<br>* Diet comparison in Gastroesophageal Reflux Disease<br>|
| Active Comparator: Low Fat Diet<br>Low Fat Diet | Other: Diet - very low carb or low fat<br>* Diet comparison in Gastroesophageal Reflux Disease<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in distal esophageal acid exposure after initiating a very low carbohydrate diet compared to the decrease seen after initiating a low fat diet |  | Baseline, 10 days after baseline, and at 25 days after baseline. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in serum levels of pro-inflammatory cytokines after initiating a very low carbohydrate diet compared to a traditional low fat diet as measured with blood samples. |  | Baseline, 10 days after baseline, and at 25 days after baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
low carbohydrate, low fat, diet, overweight, GERD, gastroesophageal reflux disease, acid reflux, heartburn