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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
  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: Double Blind (Subject, 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:

MedlinePlus related topics: GERD Heartburn
U.S. FDA Resources

Further study details as provided by 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. ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: October 2, 2009
Last Updated: January 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
low carbohydrate
low fat
diet
overweight
 GERD
gastroesophageal reflux disease
acid reflux
heartburn

Additional relevant MeSH terms:
Gastroesophageal Reflux
Overweight
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013