An interventional study of Dietary Carbohydrate in Gastroesophageal Reflux Disease and Obesity, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
4-Arm Diet Intervention Investigating Effects of Dietary Carbohydrate Type and Amount on gastroesophageal pH, gastroesophageal reflux disease (GERD) symptoms and medication use.
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.
1,086 studies on the registry are indexed under Gastroesophageal Reflux; 187 are open to participants now.
This study's enrollment of 150 is above the median of 72 across 724 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →VA Office of Research and Development is the lead sponsor of 1,767 studies on the registry; 394 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 183 (88%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age 21 or over BMI 30-39.9 GERD
Exclusion Criteria:
High total carbohydrate with high total simple carbohydrate diet
Other: Dietary Carbohydrate
High total carbohydrate with low total simple carbohydrate diet
Other: Dietary Carbohydrate
Low total carbohydrate with high total simple carbohydrate diet
Other: Dietary Carbohydrate
Low total carbohydrate with low total simple carbohydrate diet
Other: Dietary Carbohydrate
9 week menu of dietary carbohydrate modification
Gastroesophageal pH
ambulatory ph monitoring for percent time gastroesophageal ph \< 4 in 24 hrs
Time frame: 24 hours
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
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
| Milestone | HTHS | HTLS | LTHS | LTLS |
|---|---|---|---|---|
| Started | 35 | 40 | 36 | 39 |
| Completed | 22 | 26 | 22 | 25 |
| Not completed | 13 | 14 | 14 | 14 |
| Withdrew: Lost to follow-up | 13 | 14 | 14 | 14 |
ambulatory ph monitoring for percent time gastroesophageal ph \< 4 in 24 hrs
| percent time ph < 4 in 24 hrs | HTHS | HTLS | LTHS | LTLS |
|---|---|---|---|---|
| Gastroesophageal pH | 7.3 ± 12.1 | 6.6 ± 8.4 | 3.7 ± 4.2 | 4.9 ± 4.7 |
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.
| final score | HTHS | HTLS | LTHS | LTLS |
|---|---|---|---|---|
| Gastroesophageal Reflux Disease Questionnaire (GERDQ) Score | 5.1 ± 3.8 | 3.2 ± 3.1 | 4.5 ± 4.5 | 3.5 ± 2.9 |
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.
| total score | HTHS | HTLS | LTHS | LTLS |
|---|---|---|---|---|
| Gastroesophageal Scale Assessment Symptom (GSAS) Score | 5.6 ± 2.4 | 4.1 ± 2.0 | 5.6 ± 2.3 | 4.5 ± 2.1 |
Collected over 9 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HTHS | 0/35 (0%) | 0/35 (0%) | 0/35 (0%) |
| HTLS | 0/40 (0%) | 1/40 (2.5%) | 0/40 (0%) |
| LTHS | 0/36 (0%) | 0/36 (0%) | 0/36 (0%) |
| LTLS | 0/39 (0%) | 0/39 (0%) | 0/39 (0%) |
| Event | HTHS | HTLS | LTHS | LTLS |
|---|---|---|---|---|
| pill stuck in throatGastrointestinal disorders | 0/35 | 1/40 | 0/36 | 0/39 |
| Age, Categorical(Participants) | HTHS | HTLS | LTHS | LTLS | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 22 | 26 | 22 | 25 | 95 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | HTHS | HTLS | LTHS | LTLS | Total |
|---|---|---|---|---|---|
| Mean | 57.2 ± 11.1 | 58.4 ± 15.3 | 56.0 ± 12.8 | 59.9 ± 10.6 | 59.0 ± 12.5 |
| Sex: Female, Male(Participants) | HTHS | HTLS | LTHS | LTLS | Total |
|---|---|---|---|---|---|
| Female | 3 | 3 | 3 | 6 | 15 |
| Male | 19 | 23 | 19 | 19 | 80 |
| Race (NIH/OMB)(Participants) | HTHS | HTLS | LTHS | LTLS | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 11 | 14 | 11 | 14 | 50 |
| White | 11 | 12 | 11 | 11 | 45 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | HTHS | HTLS | LTHS | LTLS | Total |
|---|---|---|---|---|---|
| United States | 22 | 26 | 22 | 25 | 95 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Data will be provided as group data upon publication
Ran from Jan 2016 to primary completion in Jul 2022, 77 months.
Results were first posted in Sep 2024, 2 years 2 months after primary completion.
Of 180 non-industry interventional studies with no phase under Gastroesophageal Reflux, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 68. This study's 77 months is above that.
Counting every sponsor, half of 208 studies reached it within 31 months; a quarter within 12 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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