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Dietary Carbohydrate and GERD in Veterans (DietGERD)

Primary Purpose

Gastroesophageal Reflux Disease, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary Carbohydrate
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring GERD, diet, carbohydrate, obesity

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

HTHS

HTLS

LTHS

LTLS

Arm Description

High total carbohydrate with high total simple carbohydrate diet

High total carbohydrate with low total simple carbohydrate diet

Low total carbohydrate with low total simple carbohydrate diet

Low total carbohydrate with low total simple carbohydrate diet

Outcomes

Primary Outcome Measures

Gastroesophageal pH
ambulatory ph monitoring for gastroesophageal ph, number and frequency of reflux episodes

Secondary Outcome Measures

GERD symptoms
GERD symptoms measured weekly for 9 weeks using Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS)
GERD medication use
Weekly measure of type, amount and dose of GERD medication use
GERD symptoms
GERD symptoms measured weekly for 9 weeks using Gastroesophageal Reflux Disease Questionnaire (GERDQ)

Full Information

First Posted
March 4, 2015
Last Updated
November 17, 2022
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02384551
Brief Title
Dietary Carbohydrate and GERD in Veterans
Acronym
DietGERD
Official Title
Dietary Carbohydrate Effects on GERD in Obese Veterans: Nutritional or Hormonal?
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 25, 2016 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease, Obesity
Keywords
GERD, diet, carbohydrate, obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HTHS
Arm Type
Active Comparator
Arm Description
High total carbohydrate with high total simple carbohydrate diet
Arm Title
HTLS
Arm Type
Experimental
Arm Description
High total carbohydrate with low total simple carbohydrate diet
Arm Title
LTHS
Arm Type
Experimental
Arm Description
Low total carbohydrate with low total simple carbohydrate diet
Arm Title
LTLS
Arm Type
Experimental
Arm Description
Low total carbohydrate with low total simple carbohydrate diet
Intervention Type
Other
Intervention Name(s)
Dietary Carbohydrate
Intervention Description
9 week menu of dietary carbohydrate modification
Primary Outcome Measure Information:
Title
Gastroesophageal pH
Description
ambulatory ph monitoring for gastroesophageal ph, number and frequency of reflux episodes
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
GERD symptoms
Description
GERD symptoms measured weekly for 9 weeks using Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS)
Time Frame
9 weeks
Title
GERD medication use
Description
Weekly measure of type, amount and dose of GERD medication use
Time Frame
9 weeks
Title
GERD symptoms
Description
GERD symptoms measured weekly for 9 weeks using Gastroesophageal Reflux Disease Questionnaire (GERDQ)
Time Frame
9 weeks
Other Pre-specified Outcome Measures:
Title
Gastric hormones
Description
Plasma/serum measure of glucose, insulin, gastrin, glucagon, active ghrelin and active GLP-1
Time Frame
24 hour period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin D Niswender, MD PhD
Organizational Affiliation
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212-2637
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be provided as group data upon publication
Citations:
PubMed Identifier
35973185
Citation
Gu C, Olszewski T, King KL, Vaezi MF, Niswender KD, Silver HJ. The Effects of Modifying Amount and Type of Dietary Carbohydrate on Esophageal Acid Exposure Time and Esophageal Reflux Symptoms: A Randomized Controlled Trial. Am J Gastroenterol. 2022 Oct 1;117(10):1655-1667. doi: 10.14309/ajg.0000000000001889. Epub 2022 Jun 21.
Results Reference
result

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Dietary Carbohydrate and GERD in Veterans

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