Dietary Carbohydrate and GERD in Veterans (DietGERD)

VA Office of Research and Development

Status: Completed

Conditions: Gastroesophageal Reflux Disease; Obesity

Treatments: Other: Dietary Carbohydrate

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02384551

CLNB-006-14S

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

150 participants in 4 patient groups

HTHS

Active Comparator group

Description:

High total carbohydrate with high total simple carbohydrate diet

Treatment:

Other: Dietary Carbohydrate

HTLS

Experimental group

Description:

High total carbohydrate with low total simple carbohydrate diet

Treatment:

Other: Dietary Carbohydrate

LTHS

Experimental group

Description:

Low total carbohydrate with high total simple carbohydrate diet

Treatment:

Other: Dietary Carbohydrate

LTLS

Experimental group

Description:

Low total carbohydrate with low total simple carbohydrate diet

Treatment:

Other: Dietary Carbohydrate