Purpose

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

Conditions

Eligibility

Eligible Ages
Over 21 Years
Eligible Genders
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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
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

More Details

Status
Completed
Sponsor
VA Office of Research and Development

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.