Nashville, Tennessee 37212


Purpose:

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


Study summary:

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.


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


Study is Available At:


Original ID:

CLNB-006-14S


NCT ID:

NCT02384551


Secondary ID:


Study Acronym:

DietGERD


Brief Title:

Dietary Carbohydrate and GERD in Veterans


Official Title:

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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

21 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

VA Office of Research and Development


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

200


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Kevin D Niswender, MD PhD
Principal Investigator
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Primary Contact:Heidi J Silver, PhD
(615) 875-9355
heidi.j.silver@vumc.org
Backup Contact:Kevin D Niswender, MD PhD
(615) 936-0500
Kevin.Niswender@va.gov

Study Dates

Start Date:January 25, 2016
Completion Date:December 31, 2020
Completion Type:Anticipated
Primary Completion Date:January 31, 2020
Primary Completion Type:Anticipated
Verification Date:December 2019
Last Changed Date:December 12, 2019
First Received Date:March 4, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:GERD symptoms
Time Frame:9 weeks
Safety Issues:False
Description:GERD symptoms measured weekly for 9 weeks using Gastroesophageal Reflux Disease Questionnaire (GERDQ)
Outcome Type:Secondary Outcome
Measure:GERD medication use
Time Frame:9 weeks
Safety Issues:False
Description:Weekly measure of type, amount and dose of GERD medication use
Outcome Type:Secondary Outcome
Measure:GERD symptoms
Time Frame:9 weeks
Safety Issues:False
Description:GERD symptoms measured weekly for 9 weeks using Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS)
Outcome Type:Primary Outcome
Measure:Gastroesophageal pH
Time Frame:24 hours
Safety Issues:False
Description:ambulatory ph monitoring for gastroesophageal ph, number and frequency of reflux episodes

Study Interventions

Intervention Type:Other
Name:Dietary Carbohydrate
Description:9 week menu of dietary carbohydrate modification
Arm Name:HTHS

Study Arms

Study Arm Type:Active Comparator
Arm Name:HTHS
Description:High total carbohydrate with high total simple carbohydrate diet
Study Arm Type:Experimental
Arm Name:HTLS
Description:High total carbohydrate with low total simple carbohydrate diet
Study Arm Type:Experimental
Arm Name:LTHS
Description:Low total carbohydrate with low total simple carbohydrate diet
Study Arm Type:Experimental
Arm Name:LTLS
Description:Low total carbohydrate with low total simple carbohydrate diet

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:VA Office of Research and Development

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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