Dietary Carbohydrate and GERD in Veterans

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gastroesophageal Reflux Disease, Obesity

Intervention / Treatment
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* Other: Dietary Carbohydrate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GERD, diet, carbohydrate, obesity