Ignite Creation Date:
2025-12-24 @ 11:46 PM
Ignite Modification Date:
2026-03-01 @ 9:59 AM
Study NCT ID:
NCT02384551
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2015-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dietary Carbohydrate and GERD in Veterans
Sponsor:
Organization:
Raw JSON
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'term': 'Carbohydrates'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'heidi.j.silver@vumc.org', 'phone': '615-875-9355', 'title': 'Heidi J Silver', 'organization': 'VA ORD'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '9 weeks', 'description': 'no difference', 'eventGroups': [{'id': 'EG000', 'title': 'HTHS', 'description': 'High total carbohydrate with high total simple carbohydrate diet\n\nDietary Carbohydrate: 9 week menu of dietary carbohydrate modification', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'HTLS', 'description': 'High total carbohydrate with low total simple carbohydrate diet\n\nDietary Carbohydrate: 9 week menu of dietary carbohydrate modification', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'LTHS', 'description': 'Low total carbohydrate with high total simple carbohydrate diet\n\nDietary Carbohydrate: 9 week menu of dietary carbohydrate modification', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 0, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'LTLS', 'description': 'Low total carbohydrate with low total simple carbohydrate diet\n\nDietary Carbohydrate: 9 week menu of dietary carbohydrate modification', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 0, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'pill stuck in throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SNOMED CT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Gastroesophageal pH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HTHS', 'description': 'High total carbohydrate with high total simple carbohydrate diet\n\nDietary Carbohydrate: 9 week menu of dietary carbohydrate modification'}, {'id': 'OG001', 'title': 'HTLS', 'description': 'High total carbohydrate with low total simple carbohydrate diet\n\nDietary Carbohydrate: 9 week menu of dietary carbohydrate modification'}, {'id': 'OG002', 'title': 'LTHS', 'description': 'Low total carbohydrate with high total simple carbohydrate diet\n\nDietary Carbohydrate: 9 week menu of dietary carbohydrate modification'}, {'id': 'OG003', 'title': 'LTLS', 'description': 'Low total carbohydrate with low total simple carbohydrate diet\n\nDietary Carbohydrate: 9 week menu of dietary carbohydrate modification'}], 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'spread': '12.1', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '8.4', 'groupId': 'OG001'}, {'value': '3.7', 'spread': '4.2', 'groupId': 'OG002'}, {'value': '4.9', 'spread': '4.7', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'ambulatory ph monitoring for percent time gastroesophageal ph \\< 4 in 24 hrs', 'unitOfMeasure': 'percent time ph < 4 in 24 hrs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Gastroesophageal Reflux Disease Questionnaire (GERDQ) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HTHS', 'description': 'High total carbohydrate with high total simple carbohydrate diet\n\nDietary Carbohydrate: 9 week menu of dietary carbohydrate modification'}, {'id': 'OG001', 'title': 'HTLS', 'description': 'High total carbohydrate with low total simple carbohydrate diet\n\nDietary Carbohydrate: 9 week menu of dietary carbohydrate modification'}, {'id': 'OG002', 'title': 'LTHS', 'description': 'Low total carbohydrate with high total simple carbohydrate diet\n\nDietary Carbohydrate: 9 week menu of dietary carbohydrate modification'}, {'id': 'OG003', 'title': 'LTLS', 'description': 'Low total carbohydrate with low total simple carbohydrate diet\n\nDietary Carbohydrate: 9 week menu of dietary carbohydrate modification'}], 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '3.1', 'groupId': 'OG001'}, {'value': '4.5', 'spread': '4.5', 'groupId': 'OG002'}, {'value': '3.5', 'spread': '2.9', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '9 weeks', 'description': '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.', 'unitOfMeasure': 'final score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Gastroesophageal Scale Assessment Symptom (GSAS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HTHS', 'description': 'High total carbohydrate with high total simple carbohydrate diet\n\nDietary Carbohydrate: 9 week menu of dietary carbohydrate modification'}, {'id': 'OG001', 'title': 'HTLS', 'description': 'High total carbohydrate with low total simple carbohydrate diet\n\nDietary Carbohydrate: 9 week menu of dietary carbohydrate modification'}, {'id': 'OG002', 'title': 'LTHS', 'description': 'Low total carbohydrate with high total simple carbohydrate diet\n\nDietary Carbohydrate: 9 week menu of dietary carbohydrate modification'}, {'id': 'OG003', 'title': 'LTLS', 'description': 'Low total carbohydrate with low total simple carbohydrate diet\n\nDietary Carbohydrate: 9 week menu of dietary carbohydrate modification'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '5.6', 'spread': '2.3', 'groupId': 'OG002'}, {'value': '4.5', 'spread': '2.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '9 weeks', 'description': '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.', 'unitOfMeasure': 'total score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HTHS', 'description': 'High total carbohydrate with high total simple carbohydrate diet\n\nDietary Carbohydrate: 9 week menu of dietary carbohydrate modification'}, {'id': 'FG001', 'title': 'HTLS', 'description': 'High total carbohydrate with low total simple carbohydrate diet\n\nDietary Carbohydrate: 9 week menu of dietary carbohydrate modification'}, {'id': 'FG002', 'title': 'LTHS', 'description': 'Low total carbohydrate with high total simple carbohydrate diet\n\nDietary Carbohydrate: 9 week menu of dietary carbohydrate modification'}, {'id': 'FG003', 'title': 'LTLS', 'description': 'Low total carbohydrate with low total simple carbohydrate diet\n\nDietary Carbohydrate: 9 week menu of dietary carbohydrate modification'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '36'}, {'groupId': 'FG003', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '14'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '95', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'HTHS', 'description': 'High total carbohydrate with high total simple carbohydrate diet\n\nDietary Carbohydrate: 9 week menu of dietary carbohydrate modification'}, {'id': 'BG001', 'title': 'HTLS', 'description': 'High total carbohydrate with low total simple carbohydrate diet\n\nDietary Carbohydrate: 9 week menu of dietary carbohydrate modification'}, {'id': 'BG002', 'title': 'LTHS', 'description': 'Low total carbohydrate with high total simple carbohydrate diet\n\nDietary Carbohydrate: 9 week menu of dietary carbohydrate modification'}, {'id': 'BG003', 'title': 'LTLS', 'description': 'Low total carbohydrate with low total simple carbohydrate diet\n\nDietary Carbohydrate: 9 week menu of dietary carbohydrate modification'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '95', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.2', 'spread': '11.1', 'groupId': 'BG000'}, {'value': '58.4', 'spread': '15.3', 'groupId': 'BG001'}, {'value': '56.0', 'spread': '12.8', 'groupId': 'BG002'}, {'value': '59.9', 'spread': '10.6', 'groupId': 'BG003'}, {'value': '59.0', 'spread': '12.5', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '95', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-02-13', 'size': 583437, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-05-09T16:00', 'hasProtocol': True}, {'date': '2016-02-22', 'size': 165653, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-05-09T15:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-27', 'studyFirstSubmitDate': '2015-03-04', 'resultsFirstSubmitDate': '2023-05-24', 'studyFirstSubmitQcDate': '2015-03-04', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-27', 'studyFirstPostDateStruct': {'date': '2015-03-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastroesophageal pH', 'timeFrame': '24 hours', 'description': 'ambulatory ph monitoring for percent time gastroesophageal ph \\< 4 in 24 hrs'}], 'secondaryOutcomes': [{'measure': 'Gastroesophageal Reflux Disease Questionnaire (GERDQ) Score', 'timeFrame': '9 weeks', 'description': '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.'}, {'measure': 'Gastroesophageal Scale Assessment Symptom (GSAS) Score', 'timeFrame': '9 weeks', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['GERD', 'diet', 'carbohydrate', 'obesity'], 'conditions': ['Gastroesophageal Reflux Disease', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '35973185', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '4-Arm Diet Intervention Investigating Effects of Dietary Carbohydrate Type and Amount on gastroesophageal pH, gastroesophageal reflux disease (GERD) symptoms and medication use.', 'detailedDescription': 'delayed due to COVID related research shutdown\n\nSpecific 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.\n\nAim 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.\n\nAim 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.\n\n2a: 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.\n\n2b: 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nAge 21 or over BMI 30-39.9 GERD\n\nExclusion Criteria:\n\n* History of type 1 diabetes\n* Hernia or strictures\n* Gastroparesis\n* Extra-esophageal GERD\n* Barrett's esophagus or Esophageal adenocarcinoma\n* History of gastric or bariatric or esophageal surgery, radiation or cancer\n* History of gastrointestinal malabsorption\n* Alcohol averaging \\> 2 drinks per day during past 3 months\n* Pregnancy / Lactation"}, 'identificationModule': {'nctId': 'NCT02384551', 'acronym': 'DietGERD', 'briefTitle': 'Dietary Carbohydrate and GERD in Veterans', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Dietary Carbohydrate Effects on GERD in Obese Veterans: Nutritional or Hormonal?', 'orgStudyIdInfo': {'id': 'CLNB-006-14S'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'HTHS', 'description': 'High total carbohydrate with high total simple carbohydrate diet', 'interventionNames': ['Other: Dietary Carbohydrate']}, {'type': 'EXPERIMENTAL', 'label': 'HTLS', 'description': 'High total carbohydrate with low total simple carbohydrate diet', 'interventionNames': ['Other: Dietary Carbohydrate']}, {'type': 'EXPERIMENTAL', 'label': 'LTHS', 'description': 'Low total carbohydrate with high total simple carbohydrate diet', 'interventionNames': ['Other: Dietary Carbohydrate']}, {'type': 'EXPERIMENTAL', 'label': 'LTLS', 'description': 'Low total carbohydrate with low total simple carbohydrate diet', 'interventionNames': ['Other: Dietary Carbohydrate']}], 'interventions': [{'name': 'Dietary Carbohydrate', 'type': 'OTHER', 'description': '9 week menu of dietary carbohydrate modification', 'armGroupLabels': ['HTHS', 'HTLS', 'LTHS', 'LTLS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37212-2637', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Valley Healthcare System Nashville Campus, Nashville, TN', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Kevin D Niswender, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tennessee Valley Healthcare System Nashville Campus, Nashville, TN'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be provided as group data upon publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}