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OpenTrials
Completed

NCT Number: NCT00998244

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.

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Key information

Conditions

Gastroesophageal Reflux Disease Acid Reflux Disease Body Weight Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Heartburn Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet - very low carb or low fat

Other

Diet comparison in Gastroesophageal Reflux Disease

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Takeda Pharmaceuticals North America, Inc.

Registry information

Official study title

A Randomized, Double-Blind Crossover Study to Evaluate the Effect of a Very Low Carbohydrate Diet on Gastroesophageal Reflux Disease

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 20, 2009
Registry last updated
Jan 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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