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

University of North Carolina, Chapel Hill40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Gastroesophageal Reflux Disease Overweight Acid Reflux Disease

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in distal esophageal acid exposure after initiating a very low carbohydrate diet compared to the decrease seen after initiating a low fat diet

Time frame: Baseline, 10 days after baseline, and at 25 days after baseline.

Secondary Outcomes

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.

Time frame: Baseline, 10 days after baseline, and at 25 days after baseline