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NCT Number: NCT02384551

Dietary Carbohydrate and GERD in Veterans

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

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Key information

Conditions

Gastroesophageal Reflux Disease Body Weight Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Nashville, Tennessee, 37212-2637, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary Carbohydrate

Other

9 week menu of dietary carbohydrate modification

Primary outcomes

  1. Gastroesophageal pH

    Time frame: 24 hours

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

Secondary outcomes

  1. Gastroesophageal Reflux Disease Questionnaire (GERDQ) Score

    Time frame: 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.

  2. Gastroesophageal Scale Assessment Symptom (GSAS) Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Acronym: DietGERD

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Mar 10, 2015
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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