NCT02384551: DietGERD

Dietary Carbohydrate and GERD in Veterans

Completed NA Results posted Last updated 19 September 2024

What this trial tests

NA trial testing Dietary Carbohydrate in Gastroesophageal Reflux Disease in 150 participants. Completed in 1 July 2022.

Timeline

25 January 2016

Primary endpoint
1 July 2022

1 July 2022

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	150
Start date	25 January 2016
Primary completion	1 July 2022
Estimated completion	1 July 2022
Sites	1 location across United States

Drugs / interventions tested

• Dietary Carbohydrate

Conditions studied

• Gastroesophageal Reflux Disease — all drugs for Gastroesophageal Reflux Disease →
• Obesity — all drugs for Obesity →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

21 and older, any sex, with Gastroesophageal Reflux Disease or Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Gastroesophageal pH Primary · 24 hours

ambulatory ph monitoring for percent time gastroesophageal ph \< 4 in 24 hrs

Group	Value	95% CI
HTHS	7.3	± 12.1
HTLS	6.6	± 8.4
LTHS	3.7	± 4.2
LTLS	4.9	± 4.7

Gastroesophageal Reflux Disease Questionnaire (GERDQ) Score Secondary · 9 weeks

GERD symptoms using Gastroesophageal Reflux Disease Questionnaire (GERDQ) Score, score is based on a scale, from 0-18, with higher score indicating more symptoms. There is not a measure of central tendency, just the total score as reported.

Group	Value	95% CI
HTHS	5.1	± 3.8
HTLS	3.2	± 3.1
LTHS	4.5	± 4.5
LTLS	3.5	± 2.9

Gastroesophageal Scale Assessment Symptom (GSAS) Score Secondary · 9 weeks

GERD symptoms measured as Gastroesophageal Scale Assessment Symptom (GSAS) score. Scores range from 0-45, with higher scores indicating more symptoms. Not a measure of central tendency.

Group	Value	95% CI
HTHS	5.6	± 2.4
HTLS	4.1	± 2.0
LTHS	5.6	± 2.3
LTLS	4.5	± 2.1

Adverse events — posted to ClinicalTrials.gov

Time frame: 9 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

HTHS

Serious: 0/35 (0%)

Deaths: 0/35

HTLS

Serious: 1/40 (3%)

Deaths: 0/40

LTHS

Serious: 0/36 (0%)

Deaths: 0/36

LTLS

Serious: 0/39 (0%)

Deaths: 0/39

Serious adverse events (1 terms)

Reaction	System	HTHS	HTLS	LTHS	LTLS
pill stuck in throat	Gastrointestinal disorders	—	—	—	—

Most-reported serious reactions: pill stuck in throat.

Data from ClinicalTrials.gov NCT02384551 adverse events section.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Effects of Modifying Amount and Type of Dietary Carbohydrate on Esophageal Acid Exposure Time and Esophageal Reflux Symptoms: A Randomized Controlled Trial.
   Gu C, Olszewski T, King KL, Vaezi MF, et al · · 2022 · cited 13× · PMID 35973185 · DOI 10.14309/ajg.0000000000001889
2. Objective ambulatory pH monitoring and subjective symptom assessment of gastroesophageal reflux disease show type of carbohydrate and type of fat matter.
   Gu C, Olszewski T, Vaezi MF, Niswender KD, et al · · 2022 · cited 4× · PMID 35663436 · DOI 10.1177/17562848221101289