Back to resultsStudy to Evaluate the Effect of a Very Low Carbohydrate Diet on Gastroesophageal Reflux Disease
Primary Purpose
Gastroesophageal Reflux Disease, Overweight, Acid Reflux Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diet - very low carb or low fat
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring low carbohydrate, low fat, diet, overweight, GERD, gastroesophageal reflux disease, acid reflux, heartburn
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
Sites / Locations
- The University of North Carolina at Chapel Hill
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Very Low Carbohydrate Diet
Low Fat Diet
Arm Description
Very Low Carbohydrate Diet
Low Fat Diet
Outcomes
Primary Outcome Measures
Change in distal esophageal acid exposure after initiating a very low carbohydrate diet compared to the decrease seen after initiating a low fat diet
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00998244
First Posted
October 2, 2009
Last Updated
January 6, 2012
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Takeda Pharmaceuticals North America, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00998244
Brief Title
Study to Evaluate the Effect of a Very Low Carbohydrate Diet on Gastroesophageal Reflux Disease
Official Title
A Randomized, Double-Blind Crossover Study to Evaluate the Effect of a Very Low Carbohydrate Diet on Gastroesophageal Reflux Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Takeda Pharmaceuticals North America, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease, Overweight, Acid Reflux Disease
Keywords
low carbohydrate, low fat, diet, overweight, GERD, gastroesophageal reflux disease, acid reflux, heartburn
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Very Low Carbohydrate Diet
Arm Type
Experimental
Arm Description
Very Low Carbohydrate Diet
Arm Title
Low Fat Diet
Arm Type
Active Comparator
Arm Description
Low Fat Diet
Intervention Type
Other
Intervention Name(s)
Diet - very low carb or low fat
Intervention Description
Diet comparison in Gastroesophageal Reflux Disease
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas J Shaheen, MD, MPH
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate the Effect of a Very Low Carbohydrate Diet on Gastroesophageal Reflux Disease
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