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

This study has been completed.
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Nicholas Shaheen, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00998244
First received: October 2, 2009
Last updated: January 6, 2012
Last verified: January 2012
History of Changes

October 2, 2009
January 6, 2012
September 2009
December 2011   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00998244 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study to Evaluate the Effect of a Very Low Carbohydrate Diet on Gastroesophageal Reflux Disease
A Randomized, Double-Blind Crossover Study to Evaluate the Effect of a Very Low Carbohydrate Diet on Gastroesophageal Reflux Disease

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Gastroesophageal Reflux Disease
  • Overweight
  • Acid Reflux Disease
Other: Diet - very low carb or low fat
Diet comparison in Gastroesophageal Reflux Disease
  • Experimental: Very Low Carbohydrate Diet
    Very Low Carbohydrate Diet
    Intervention: Other: Diet - very low carb or low fat
  • Active Comparator: Low Fat Diet
    Low Fat Diet
    Intervention: Other: Diet - very low carb or low fat
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00998244
07-0623
No
Nicholas Shaheen, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
Takeda Pharmaceuticals North America, Inc.
Principal Investigator: Nicholas J Shaheen, MD, MPH University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP