DietGERD: Dietary Carbohydrate and GERD in Veterans

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Active, not recruiting
CT.gov ID
NCT02384551
Collaborator
(none)
90
1
4
77.2
1.2

Study Details

Study Description

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
  • Other: Dietary Carbohydrate
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
90 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 :
Jan 25, 2016
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Gastroesophageal pH [24 hours]

    ambulatory ph monitoring for gastroesophageal ph, number and frequency of reflux episodes

Secondary Outcome Measures

  1. GERD symptoms [9 weeks]

    GERD symptoms measured weekly for 9 weeks using Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS)

  2. GERD medication use [9 weeks]

    Weekly measure of type, amount and dose of GERD medication use

  3. GERD symptoms [9 weeks]

    GERD symptoms measured weekly for 9 weeks using Gastroesophageal Reflux Disease Questionnaire (GERDQ)

Other Outcome Measures

  1. Gastric hormones [24 hour period]

    Plasma/serum measure of glucose, insulin, gastrin, glucagon, active ghrelin and active GLP-1

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tennessee Valley Healthcare System Nashville Campus, Nashville, TN Nashville Tennessee United States 37212-2637

Sponsors and Collaborators

  • VA Office of Research and Development

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT02384551
Other Study ID Numbers:
  • CLNB-006-14S
First Posted:
Mar 10, 2015
Last Update Posted:
Jan 28, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 28, 2022