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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00998244
Recruitment Status : Completed
First Posted : October 20, 2009
Last Update Posted : January 9, 2012
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Nicholas Shaheen, University of North Carolina, Chapel Hill

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Overweight Acid Reflux Disease Other: Diet - very low carb or low fat Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Crossover Study to Evaluate the Effect of a Very Low Carbohydrate Diet on Gastroesophageal Reflux Disease
Study Start Date : September 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arms and Interventions
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Arm Intervention/treatment
Experimental: Very Low Carbohydrate Diet
Very Low Carbohydrate Diet
 Other: Diet - very low carb or low fat
Diet comparison in Gastroesophageal Reflux Disease
Active Comparator: Low Fat Diet
Low Fat Diet
 Other: Diet - very low carb or low fat
Diet comparison in Gastroesophageal Reflux Disease


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00998244


Locations
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United States, North Carolina
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Takeda Pharmaceuticals North America, Inc.
Investigators
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Principal Investigator: Nicholas J Shaheen, MD, MPH University of North Carolina, Chapel Hill
More Information
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Responsible Party: Nicholas Shaheen, Professor of Medicine, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00998244    
Other Study ID Numbers: 07-0623
First Posted: October 20, 2009    Key Record Dates
Last Update Posted: January 9, 2012
Last Verified: January 2012
Keywords provided by Nicholas Shaheen, University of North Carolina, Chapel Hill:
low carbohydrate
low fat
diet
overweight
 GERD
gastroesophageal reflux disease
acid reflux
heartburn
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases