Status:
COMPLETED
Study to Evaluate the Effect of a Very Low Carbohydrate Diet on Gastroesophageal Reflux Disease
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Takeda Pharmaceuticals North America, Inc.
Conditions:
Gastroesophageal Reflux Disease
Overweight
Eligibility:
All Genders
18-70 years
Phase:
NA
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 peopl...
Eligibility Criteria
Inclusion
- 18 to 70 years old
- BMI between 30 kg/m2 and 45 kg/m2
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00998244
Start Date
September 1 2009
End Date
December 1 2011
Last Update
January 9 2012
Active Locations (1)
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1
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514