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

University of North Carolina (UNC)

Status: Completed

Conditions: Overweight; Acid Reflux Disease; Gastroesophageal Reflux Disease

Treatments: Other: Diet - very low carb or low fat

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00998244

07-0623

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

40 participants in 2 patient groups

Very Low Carbohydrate Diet

Experimental group

Description:

Very Low Carbohydrate Diet

Treatment:

Other: Diet - very low carb or low fat

Low Fat Diet

Active Comparator group

Description:

Low Fat Diet

Treatment:

Other: Diet - very low carb or low fat