Dietary Carbohydrate and GERD in Veterans

Obesity Clinical Trial

— DietGERD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02384551
• Other study ID #: CLNB-006-14S
• Status: Completed
• Phase: N/A
• Start date: January 25, 2016
• Est. completion date: July 1, 2022

Study information

• Verified date: November 2022
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease
• Obesity

Intervention

Other:
• Dietary Carbohydrate
9 week menu of dietary carbohydrate modification

Locations

Country	Name	City	State
United States	Tennessee Valley Healthcare System Nashville Campus, Nashville, TN	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gu C, Olszewski T, King KL, Vaezi MF, Niswender KD, Silver HJ. The Effects of Modifying Amount and Type of Dietary Carbohydrate on Esophageal Acid Exposure Time and Esophageal Reflux Symptoms: A Randomized Controlled Trial. Am J Gastroenterol. 2022 Oct 1; — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gastric hormones	Plasma/serum measure of glucose, insulin, gastrin, glucagon, active ghrelin and active GLP-1	24 hour period
Primary	Gastroesophageal pH	ambulatory ph monitoring for gastroesophageal ph, number and frequency of reflux episodes	24 hours
Secondary	GERD symptoms	GERD symptoms measured weekly for 9 weeks using Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS)	9 weeks
Secondary	GERD medication use	Weekly measure of type, amount and dose of GERD medication use	9 weeks
Secondary	GERD symptoms	GERD symptoms measured weekly for 9 weeks using Gastroesophageal Reflux Disease Questionnaire (GERDQ)	9 weeks