Dietary Carbohydrate and GERD in Veterans (DietGERD)

November 17, 2022 updated by: VA Office of Research and Development

Dietary Carbohydrate Effects on GERD in Obese Veterans: Nutritional or Hormonal?

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37212-2637
        • Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: HTHS
High total carbohydrate with high total simple carbohydrate diet
Other: Dietary Carbohydrate
9 week menu of dietary carbohydrate modification
Experimental: HTLS
High total carbohydrate with low total simple carbohydrate diet
Other: Dietary Carbohydrate
9 week menu of dietary carbohydrate modification
Experimental: LTHS
Low total carbohydrate with low total simple carbohydrate diet
Other: Dietary Carbohydrate
9 week menu of dietary carbohydrate modification
Experimental: LTLS
Low total carbohydrate with low total simple carbohydrate diet
Other: Dietary Carbohydrate
9 week menu of dietary carbohydrate modification

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastroesophageal pH
Time Frame: 24 hours
ambulatory ph monitoring for gastroesophageal ph, number and frequency of reflux episodes
24 hours

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric hormones
Time Frame: 24 hour period
Plasma/serum measure of glucose, insulin, gastrin, glucagon, active ghrelin and active GLP-1
24 hour period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Kevin D Niswender, MD PhD, Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2016

Primary Completion (Actual)

July 1, 2022

Study Completion (Actual)

July 1, 2022

Study Registration Dates

First Submitted

March 4, 2015

First Submitted That Met QC Criteria

March 4, 2015

First Posted (Estimate)

March 10, 2015

Study Record Updates

Last Update Posted (Actual)

November 22, 2022

Last Update Submitted That Met QC Criteria

November 17, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLNB-006-14S

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Data will be provided as group data upon publication

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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