The Effects of Modifying Amount and Type of Dietary Carbohydrate on Esophageal Acid Exposure Time and Esophageal Reflux Symptoms: A Randomized Controlled Trial.

"CONFLICTS OF INTEREST Guarantor of the article: Heidi J. Silver, RD, MS, PhD. Specific author contributions: H.J.S. and K.D.N.: study concept, study design, and funding. T.O., K.L.K., and H.J.S.: protocol implementation. C.G., T.O., and K.L.K.: data acquisition and database entry. C.G. and H.J.S.: statistical analysis. C.G. and H.J.S.: manuscript development. C.G., T.O., M.F.V., K.D.N., and H.J.S.: manuscript revisions and final draft. Financial support: This study was funded by VA Merit Award #CX001009-05. Potential competing interests: None to report. Trail registration:ClinicalTrials.gov NCT02384551.Study HighlightsWHAT IS KNOWN✓ Gastroesophageal reflux disease (GERD) is the most frequent and most costly gastrointestinal disorder.✓ Dietary recommendations are a component of first-line treatment.✓ Dietary recommendations typically focus on avoiding or eliminating foods that are perceived to trigger symptoms.✓ Objective scientific evidence on the impact of foods and nutrients remains lacking.WHAT IS NEW HERE✓ This is the first randomized controlled parallel-group study to determine the effects of both the amount and type of carbohydrate on symptomatic GERD.✓ Ambulatory 24-hour pH monitoring shows that modifying the type of carbohydrate consumed, simple sugars, reduces total acid exposure time and total number of reflux episodes.✓ Subjective ratings of GERD symptoms, including heartburn and reflux, were also significantly improved by reducing dietary carbohydrate amount and type (simple sugars).✓ Providing guidance on reducing intake of carbohydrates is a feasible and pragmatic dietary strategy to include in the management of symptomatic GERD."

"Financial support: This study was funded by VA Merit Award #CX001009-05."

"Subjects were recruited from the Tennessee Valley Healthcare System (TVHS, Department of Veterans Affairs, Nashville, TN) on responding to flyers posted in the TVHS primary care outpatient clinics or a study-specific advertisement aired weekly on the internal TVHS television system. In addition, an institutional review board-approved HIPAA waiver allowed the VA Informatics and Computing Infrastructure to generate lists of patients receiving proton pump inhibitor (PPI) prescriptions (omeprazole or pantoprazole) from the TVHS outpatient pharmacy within the previous 6 months. To be included, veterans had GERD diagnosis documented in the electronic medical record on assessment of the classic GERD symptoms (heartburn and regurgitation) by their attending physician and PPI prescription from the TVHS outpatient pharmacy for ≥ 3 months before enrollment. In addition, subjects were older than 21 years and had BMI between 25.0 and 45.0 kg/m2. Exclusion criteria were as follows: diagnosed with type 1 diabetes, esophageal stricture, extraesophageal GERD, Barrett's esophagus, gastroparesis or esophageal motility disorders, esophageal adenocarcinoma or other cancer, or a history of esophageal or bariatric surgery. Potential subjects were also excluded if they had a hiatal hernia of >5 cm, had food allergies or dietary restrictions, had gastrointestinal malabsorption, had alcohol consumption averaging >2 drinks/day during the 3 months before enrollment, or were pregnant or lactating. This study was registered on ClinicalTrials.gov (NCT02384551) and approved by the TVHS (IRB#676769-14) and the Vanderbilt University Medical Center (IRB#141715) Institutional Review Boards, and all subjects signed written informed consent. All authors had access to the data and approved the final manuscript."