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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HTHS | Active Comparator | High total carbohydrate with high total simple carbohydrate diet |
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| HTLS | Experimental | High total carbohydrate with low total simple carbohydrate diet |
|
| LTHS | Experimental | Low total carbohydrate with high total simple carbohydrate diet |
|
| LTLS | Experimental | Low total carbohydrate with low total simple carbohydrate diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Carbohydrate | Other | 9 week menu of dietary carbohydrate modification |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gastroesophageal pH | ambulatory ph monitoring for percent time gastroesophageal ph < 4 in 24 hrs | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 9 weeks |
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Inclusion Criteria:
Age 21 or over BMI 30-39.9 GERD
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin D Niswender, MD PhD | Tennessee Valley Healthcare System Nashville Campus, Nashville, TN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tennessee Valley Healthcare System Nashville Campus, Nashville, TN | Nashville | Tennessee | 37212-2637 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35973185 | Result | 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;117(10):1655-1667. doi: 10.14309/ajg.0000000000001889. Epub 2022 Jun 21. |
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Data will be provided as group data upon publication
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| ID | Title | Description |
|---|---|---|
| FG000 | HTHS | High total carbohydrate with high total simple carbohydrate diet Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification |
| FG001 | HTLS | High total carbohydrate with low total simple carbohydrate diet Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification |
| FG002 | LTHS | Low total carbohydrate with high total simple carbohydrate diet Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification |
| FG003 | LTLS | Low total carbohydrate with low total simple carbohydrate diet Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HTHS | High total carbohydrate with high total simple carbohydrate diet Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification |
| BG001 | HTLS | High total carbohydrate with low total simple carbohydrate diet Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Gastroesophageal pH | ambulatory ph monitoring for percent time gastroesophageal ph < 4 in 24 hrs | Posted | Mean | Standard Deviation | percent time ph < 4 in 24 hrs | 24 hours |
|
9 weeks
no difference
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HTHS | High total carbohydrate with high total simple carbohydrate diet Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pill stuck in throat | Gastrointestinal disorders | SNOMED CT | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heidi J Silver | VA ORD | 615-875-9355 | heidi.j.silver@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 13, 2019 | May 9, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 22, 2016 | May 9, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D004040 | Dietary Carbohydrates |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| 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. |
| 9 weeks |
| BG002 | LTHS | Low total carbohydrate with high total simple carbohydrate diet Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification |
| BG003 | LTLS | Low total carbohydrate with low total simple carbohydrate diet Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Low total carbohydrate with high total simple carbohydrate diet Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification |
| OG003 | LTLS | Low total carbohydrate with low total simple carbohydrate diet Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification |
|
|
| 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. | Posted | Mean | Standard Deviation | final score | 9 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | total score | 9 weeks |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | HTLS | High total carbohydrate with low total simple carbohydrate diet Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification | 0 | 40 | 1 | 40 | 0 | 40 |
| EG002 | LTHS | Low total carbohydrate with high total simple carbohydrate diet Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification | 0 | 36 | 0 | 36 | 0 | 36 |
| EG003 | LTLS | Low total carbohydrate with low total simple carbohydrate diet Dietary Carbohydrate: 9 week menu of dietary carbohydrate modification | 0 | 39 | 0 | 39 | 0 | 39 |
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| D004066 | Digestive System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019602 |
| Food and Beverages |