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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Dietary Carbohydrate and GERD in Veterans

NCT02384551

Gastroesophageal Reflux Disease Obesity

COMPLETED NA

Medical and Surgical Treatment of Esophageal Reflux

NCT00061724

Gastroesophageal Reflux

COMPLETED

Efficacy Of Hiatal Closure For GERD

NCT06280664

Gastro Esophageal Reflux

RECRUITING

Impact of Weight Loss on Gastroesophageal Reflux Disease in Overweight and Obese Subjects: a Prospective Study

NCT01574573

GERD Obesity

TERMINATED NA

FODMAPs and Refractory GERD

NCT02471989

Gastro-esophageal Reflux Disease (GERD)

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastroesophageal Reflux Disease Overweight Acid Reflux Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Very Low Carbohydrate Diet

Group Type EXPERIMENTAL

Diet - very low carb or low fat

Intervention Type OTHER

Diet comparison in Gastroesophageal Reflux Disease

Low Fat Diet

Group Type ACTIVE_COMPARATOR

Diet - very low carb or low fat

Intervention Type OTHER

Diet comparison in Gastroesophageal Reflux Disease

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Diet - very low carb or low fat

Diet comparison in Gastroesophageal Reflux Disease

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No