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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00998244

Enrollment

Registered

2009-10-20

Start date

2009-09-30

Completion date

2011-12-31

Last updated

2012-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acid Reflux Disease, Gastroesophageal Reflux Disease, Overweight

Keywords

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

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.

Interventions

OTHERDiet - very low carb or low fat

Diet comparison in Gastroesophageal Reflux Disease

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026