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

Not Applicable

Completed

• Conditions: Gastroesophageal Reflux Disease; Overweight; Acid Reflux Disease
• Interventions: Other: Diet - very low carb or low fat

• Registration Number: NCT00998244
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-10-02
• Study First Submitted QC: 2009-10-19
• Study First Posted: 2009-10-20
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-06
• Last Update Posted: 2012-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 18 to 70 years old
• BMI between 30 kg/m2 and 45 kg/m2

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Very Low Carbohydrate Diet	Diet - very low carb or low fat	Very Low Carbohydrate Diet
Low Fat Diet	Diet - very low carb or low fat	Low Fat Diet

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

The University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States