Gastroesophageal Reflux Disease, Obesity
Conditions
Keywords
GERD, diet, carbohydrate, obesity
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.
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.
Interventions
OTHERDietary Carbohydrate
9 week menu of dietary carbohydrate modification
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastroesophageal pH | 24 hours | ambulatory ph monitoring for percent time gastroesophageal ph \< 4 in 24 hrs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastroesophageal Reflux Disease Questionnaire (GERDQ) Score | 9 weeks | GERD symptoms using Gastroesophageal Reflux Disease Questionnaire (GERDQ) Score, score is based on a scale, from 0-18, with higher score indicating more symptoms. There is not a measure of central tendency, just the total score as reported. |
| Gastroesophageal Scale Assessment Symptom (GSAS) Score | 9 weeks | GERD symptoms measured as Gastroesophageal Scale Assessment Symptom (GSAS) score. Scores range from 0-45, with higher scores indicating more symptoms. Not a measure of central tendency. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HTHS High total carbohydrate with high total simple carbohydrate diet
Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification | 22 |
| HTLS High total carbohydrate with low total simple carbohydrate diet
Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification | 26 |
| LTHS Low total carbohydrate with high total simple carbohydrate diet
Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification | 22 |
| LTLS Low total carbohydrate with low total simple carbohydrate diet
Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification | 25 |
| Total | 95 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 13 | 14 | 14 | 14 |
Baseline characteristics
| Characteristic | HTLS | LTHS | LTLS | HTHS | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 22 Participants | 25 Participants | 22 Participants | 95 Participants |
| Age, Continuous | 58.4 years STANDARD_DEVIATION 15.3 | 56.0 years STANDARD_DEVIATION 12.8 | 59.9 years STANDARD_DEVIATION 10.6 | 57.2 years STANDARD_DEVIATION 11.1 | 59.0 years STANDARD_DEVIATION 12.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 11 Participants | 14 Participants | 11 Participants | 50 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 11 Participants | 11 Participants | 11 Participants | 45 Participants |
| Region of Enrollment United States | 26 Participants | 22 Participants | 25 Participants | 22 Participants | 95 Participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 6 Participants | 3 Participants | 15 Participants |
| Sex: Female, Male Male | 23 Participants | 19 Participants | 19 Participants | 19 Participants | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 40 | 0 / 36 | 0 / 39 |
| other Total, other adverse events | 0 / 35 | 0 / 40 | 0 / 36 | 0 / 39 |
| serious Total, serious adverse events | 0 / 35 | 1 / 40 | 0 / 36 | 0 / 39 |
Outcome results
Primary
Gastroesophageal pH
ambulatory ph monitoring for percent time gastroesophageal ph \< 4 in 24 hrs
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HTHS | Gastroesophageal pH | 7.3 percent time ph < 4 in 24 hrs | Standard Deviation 12.1 |
| HTLS | Gastroesophageal pH | 6.6 percent time ph < 4 in 24 hrs | Standard Deviation 8.4 |
| LTHS | Gastroesophageal pH | 3.7 percent time ph < 4 in 24 hrs | Standard Deviation 4.2 |
| LTLS | Gastroesophageal pH | 4.9 percent time ph < 4 in 24 hrs | Standard Deviation 4.7 |
Secondary
Gastroesophageal Reflux Disease Questionnaire (GERDQ) Score
GERD symptoms using Gastroesophageal Reflux Disease Questionnaire (GERDQ) Score, score is based on a scale, from 0-18, with higher score indicating more symptoms. There is not a measure of central tendency, just the total score as reported.
Time frame: 9 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HTHS | Gastroesophageal Reflux Disease Questionnaire (GERDQ) Score | 5.1 final score | Standard Deviation 3.8 |
| HTLS | Gastroesophageal Reflux Disease Questionnaire (GERDQ) Score | 3.2 final score | Standard Deviation 3.1 |
| LTHS | Gastroesophageal Reflux Disease Questionnaire (GERDQ) Score | 4.5 final score | Standard Deviation 4.5 |
| LTLS | Gastroesophageal Reflux Disease Questionnaire (GERDQ) Score | 3.5 final score | Standard Deviation 2.9 |
Secondary
Gastroesophageal Scale Assessment Symptom (GSAS) Score
GERD symptoms measured as Gastroesophageal Scale Assessment Symptom (GSAS) score. Scores range from 0-45, with higher scores indicating more symptoms. Not a measure of central tendency.
Time frame: 9 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HTHS | Gastroesophageal Scale Assessment Symptom (GSAS) Score | 5.6 total score | Standard Deviation 2.4 |
| HTLS | Gastroesophageal Scale Assessment Symptom (GSAS) Score | 4.1 total score | Standard Deviation 2 |
| LTHS | Gastroesophageal Scale Assessment Symptom (GSAS) Score | 5.6 total score | Standard Deviation 2.3 |
| LTLS | Gastroesophageal Scale Assessment Symptom (GSAS) Score | 4.5 total score | Standard Deviation 2.1 |