N/A N=150 Randomized Single-blind Treatment

Dietary Carbohydrate and GERD in Veterans

Gastroesophageal Reflux Disease · Obesity

Bottom Line

View on ClinicalTrials.gov: NCT02384551 ↗

Enrolled (actual)

150

Serious AEs

0.7%

Results posted

Sep 2024

Primary outcome: Primary: Gastroesophageal pH — 7.3; 6.6; 3.7; 4.9 percent time ph < 4 in 24 hrs

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Dietary Carbohydrate (Other)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Jul 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Gastroesophageal pH	7.3; 6.6; 3.7; 4.9	—
SECONDARY Gastroesophageal Reflux Disease Questionnaire (GERDQ) Score	5.1; 3.2; 4.5; 3.5	—
SECONDARY Gastroesophageal Scale Assessment Symptom (GSAS) Score	5.6; 4.1; 5.6; 4.5	—

Summary

4-Arm Diet Intervention Investigating Effects of Dietary Carbohydrate Type and Amount on gastroesophageal pH, gastroesophageal reflux disease (GERD) symptoms and medication use.

Eligibility Criteria

Inclusion Criteria

Age 21 or over BMI 30-39.9 GERD

Exclusion Criteria

History of type 1 diabetes
Hernia or strictures
Gastroparesis
Extra-esophageal GERD
Barrett's esophagus or Esophageal adenocarcinoma
History of gastric or bariatric or esophageal surgery, radiation or cancer
History of gastrointestinal malabsorption
Alcohol averaging > 2 drinks per day during past 3 months
Pregnancy / Lactation

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02384551). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.