Dietary Carbohydrate and GERD in Veterans

Not Applicable

Completed

• Conditions: Gastroesophageal Reflux Disease; Obesity
• Interventions: Other: Dietary Carbohydrate

• Registration Number: NCT02384551
• Lead Sponsor: VA Office of Research and Development

Brief Summary

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

Detailed Description

delayed due to COVID related research shutdown

Specific Hypothesis: The preliminary findings suggest a physiological mechanism between dietary intake and GERD that may be related to type of dietary carbohydrate intake (complex vs simple carbohydrate). The investigators hypothesize that modifying the type of dietary carbohydrate consumed - by reducing the proportion of simple carbohydrate (sugars) consumed - will reduce or resolve GERD symptoms and medication use in obese Veterans with chronic GERD. The investigators further hypothesize that the mechanistic effects of reducing simple carbohydrate intake is related to either: a) improved dietary fiber intake and/or glycemic load, and thus, reduced amount and duration of esophageal acid exposure; and/or b) improved insulin sensitivity which would positively influence the function of key gastrointestinal hormones (ie, gastrin, glucagon, GLP-1, ghrelin11) that regulate gastric motility and/or lower esophageal sphincter function.

Aim 1: To determine effects of dietary carbohydrate consumed (amount and type) on percent time with esophageal pH \< 4.0, as well as number of reflux episodes, GERD symptoms and GERD medication use, in 200 obese Veterans who have chronic high frequency of GERD symptoms. To meet this aim the investigators will use a randomized controlled trial in which the investigators manipulate amount of total and simple dietary carbohydrate intake for duration of 9 weeks.

Aim 2: To assess associations between GERD resolution variables and factors related to potential mechanisms by which modifying dietary carbohydrate intake could resolve/reduce GERD in obese Veterans.

2a: The investigators will investigate associations related to whether the effect is nutritionally mediated by measuring change in dietary fiber load and dietary glycemic load, and thus, whether these changes are related to improved gastric acid secretion (% time pH \< 4), gastric motility, and/or the other parameters that comprise the Johnson-DeMeester score.

2b: The investigators will also investigate whether effects are associated with changes in the hormonal milieu by measuring hormonal response of gastrin, glucagon, glucagon-like peptide-1 (GLP-1), ghrelin and insulin, which could potentially influence gastric acid secretion, gastric motility and/or lower esophageal sphincter function.

Study Timeline

• Study First Submitted: 2015-03-04
• Study First Submitted QC: 2015-03-04
• Study First Posted: 2015-03-10
• Study Start: 2016-01-25
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-01
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-17
• Last Update Posted: 2022-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Age 21 or over BMI 30-39.9 GERD

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HTHS	Dietary Carbohydrate	High total carbohydrate with high total simple carbohydrate diet
HTLS	Dietary Carbohydrate	High total carbohydrate with low total simple carbohydrate diet
LTHS	Dietary Carbohydrate	Low total carbohydrate with high total simple carbohydrate diet
LTLS	Dietary Carbohydrate	Low total carbohydrate with low total simple carbohydrate diet

Primary Outcome Measures

Name	Time	Method
Gastroesophageal pH	24 hours	ambulatory ph monitoring for percent time gastroesophageal ph \< 4 in 24 hrs

Secondary Outcome Measures

Name	Time	Method
Gastroesophageal Reflux Disease Questionnaire (GERDQ) Score	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.
Gastroesophageal Scale Assessment Symptom (GSAS) Score	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.

Trial Locations

Locations (1)

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN; 🇺🇸 Nashville, Tennessee, United States