Dietary Carbohydrate and GERD in Veterans
| Status: | Recruiting |
|---|---|
| Conditions: | Gastroesophageal Reflux Disease , Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology, Gastroenterology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 1/11/2019 |
| Start Date: | January 25, 2016 |
| End Date: | December 31, 2020 |
| Contact: | Heidi J Silver, PhD |
| Email: | heidi.j.silver@vumc.org |
| Phone: | (615) 875-9355 |
Dietary Carbohydrate Effects on GERD in Obese Veterans: Nutritional or Hormonal?
4-Arm Diet Intervention Investigating Effects of Dietary Carbohydrate Type and Amount on
gastroesophageal pH, gastroesophageal reflux disease (GERD) symptoms and medication use.
gastroesophageal pH, gastroesophageal reflux disease (GERD) symptoms and medication use.
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.
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.
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
We found this trial at
1
site
Nashville, Tennessee 37212
Principal Investigator: Kevin D Niswender, MD PhD
Phone: 615-936-0500
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