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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:
ClinicalTrials.gov Identifier:
NCT00998244
First Posted: October 20, 2009
Last Update Posted: January 9, 2012
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.
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Nicholas Shaheen, University of North Carolina, Chapel Hill
  Purpose
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 Intervention
Gastroesophageal Reflux Disease Overweight Acid Reflux Disease Other: Diet - very low carb or low fat

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Nicholas Shaheen, University of North Carolina, Chapel Hill:

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 [ Time Frame: Baseline, 10 days after baseline, and at 25 days after baseline. ]

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. [ Time Frame: Baseline, 10 days after baseline, and at 25 days after baseline ]

Enrollment: 40
Study Start Date: September 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
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
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
Principal Investigator: Nicholas J Shaheen, MD, MPH University of North Carolina, Chapel Hill
  More Information

Responsible Party: Nicholas Shaheen, Professor of Medicine, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00998244     History of Changes
Other Study ID Numbers: 07-0623
First Submitted: October 2, 2009
First Posted: October 20, 2009
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:
Overweight
Gastroesophageal Reflux
Body Weight
Signs and Symptoms
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases