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Dietary Carbohydrate and GERD in Veterans (DietGERD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02384551
Recruitment Status : Recruiting
First Posted : March 10, 2015
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Obesity Other: Dietary Carbohydrate Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Dietary Carbohydrate Effects on GERD in Obese Veterans: Nutritional or Hormonal?
Actual Study Start Date : January 25, 2016
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Carbohydrates GERD

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




Primary Outcome Measures :
  1. Gastroesophageal pH [ Time Frame: 24 hours ]
    ambulatory ph monitoring for gastroesophageal ph, number and frequency of reflux episodes


Secondary Outcome Measures :
  1. GERD symptoms [ Time Frame: 9 weeks ]
    GERD symptoms measured weekly for 9 weeks using Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS)

  2. GERD medication use [ Time Frame: 9 weeks ]
    Weekly measure of type, amount and dose of GERD medication use

  3. GERD symptoms [ Time Frame: 9 weeks ]
    GERD symptoms measured weekly for 9 weeks using Gastroesophageal Reflux Disease Questionnaire (GERDQ)


Other Outcome Measures:
  1. Gastric hormones [ Time Frame: 24 hour period ]
    Plasma/serum measure of glucose, insulin, gastrin, glucagon, active ghrelin and active GLP-1



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02384551


Contacts
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Contact: Heidi J Silver, PhD (615) 875-9355 heidi.j.silver@vumc.org
Contact: Kevin D Niswender, MD PhD (615) 936-0500 Kevin.Niswender@va.gov

Locations
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United States, Tennessee
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN Recruiting
Nashville, Tennessee, United States, 37212-2637
Contact: Kevin D Niswender, MD PhD    615-936-0500    Kevin.Niswender@va.gov   
Contact: Heidi J Silver, PhD    (615) 875-9355    heidi.j.silver@vumc.org   
Principal Investigator: Kevin D Niswender, MD PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Kevin D Niswender, MD PhD Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02384551    
Other Study ID Numbers: CLNB-006-14S
First Posted: March 10, 2015    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by VA Office of Research and Development:
GERD
diet
carbohydrate
obesity
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases