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

NCT00998244 | Completed

• 1 other identifier: 07-0623
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux Disease; Overweight; Acid Reflux Disease

Keywords

low carbohydrate; low fat; diet; overweight; GERD; gastroesophageal reflux disease; acid reflux; heartburn

Outcome Measures

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

  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.

  Baseline, 10 days after baseline, and at 25 days after baseline

Study Arms (2)

Very Low Carbohydrate Diet

EXPERIMENTAL

Very Low Carbohydrate Diet

Other: Diet - very low carb or low fat

Low Fat Diet

ACTIVE COMPARATOR

Low Fat Diet

Other: Diet - very low carb or low fat

Interventions

Diet - very low carb or low fat OTHER

Diet comparison in Gastroesophageal Reflux Disease

Low Fat Diet; Very Low Carbohydrate Diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 70 years old
• BMI between 30 kg/m2 and 45 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Takeda Pharmaceuticals North America, Inc.: collaborator

Study Sites (1)

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Overweight; Heartburn

Interventions

Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Nicholas J Shaheen, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: October 2, 2009
• First Posted: October 20, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 9, 2012

Record last verified: 2012-01

Locations

US (1)