Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-28 @ 6:21 PM
Study NCT ID:
NCT01122160
Status:
COMPLETED
Last Update Posted:
2013-08-23
First Post:
2010-05-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Gastric pH and Anthocyanin Absorption
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009853', 'term': 'Omeprazole'}], 'ancestors': [{'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'beverly.clevidence@ars.usda.gov', 'phone': '301-504-8367', 'title': 'Beverly Clevidence', 'organization': 'USDA'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Experimental', 'otherNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'otherNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Gastric pH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental'}, {'id': 'OG001', 'title': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.96', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '2.31', 'spread': '0.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hour prior to gastric emptying on Day 7 of the given intervention', 'unitOfMeasure': 'pH', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo First, Then Omeprazole', 'description': 'Placebo with berries (blackberries + strawberries), followed by Omeprazole with berries (blackberries + strawberries)'}, {'id': 'FG001', 'title': 'Omeprazole First, Then Placebo', 'description': 'Prilosec (omeprazole) 20.6 mg tablet with berries (blackberries + strawberries), followed by placebo with berries (blackberries + strawberries)'}], 'periods': [{'title': 'First Intervention (7 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout (7-14 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention (7 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Discrepancy between actual enrollment and number of participants in participant flow module is due to enrolled participants no longer meeting exclusion criteria (i.e., inability to swallow capsule).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'All participants received both interventions.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35', 'spread': '13.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-23', 'studyFirstSubmitDate': '2010-05-10', 'resultsFirstSubmitDate': '2012-12-17', 'studyFirstSubmitQcDate': '2010-05-10', 'lastUpdatePostDateStruct': {'date': '2013-08-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-07-23', 'studyFirstPostDateStruct': {'date': '2010-05-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastric pH', 'timeFrame': '1 hour prior to gastric emptying on Day 7 of the given intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['anthocyanin', 'omeprazole', 'Prilosec', 'gastric pH', 'proton pump inhibitor', 'PPI', 'nutrition'], 'conditions': ['Anthocyanin Metabolism']}, 'descriptionModule': {'briefSummary': 'Anthocyanins are phytonutrients that provide blue, purple and red colors to fruits and vegetables. The purpose of the study is to determine whether absorption of anthocyanins occurs in the acid pH of the stomach and to determine whether altering stomach pH by use of an over-the-counter medicine, Prilosec TM, alters absorption of anthocyanins from strawberries and blackberries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* BMI 18.5 kg/m2 to 30 kg/m2\n* Age 22 to 59 years\n\nExclusion Criteria:\n\n* Plans to have MRI analysis or other contact with MRI equipment during the study\n* Has implanted or portable electro-mechanical medical device such as a cardiac pacemaker or infusion pump\n* Suspected strictures, fistulas or physiological GI obstruction\n* Allergy to omeprazole\n* Current use of clopidogrel (Plavix) or use within the past 3 months\n* Use of warfarin, prescription antifungals/anti-yeast drugs, diazepam, and digoxin\n* Chronic daily use of nonsteroidal anti-inflammatory drugs (ibuprofen, naproxen, etc.)\n* History of bariatric or other gastric surgery\n* Frequent use of antacids\n* Use of proton pump inhibitors in past 3 months\n* History of acid reflux\n* History of gastrointestinal disorders or gastrointestinal surgery\n* History of bezoars (packed collection of partially digested or undigested material that is unable to exit the stomach)\n* Crohn's disease, diverticulitis or inflammatory bowel disease\n* Inability to swallow large pills\n* Dysphagia (Trouble or pain with swallowing food or pills)\n* Allergy to strawberries or blackberries\n* Pregnant women\n* Lactating women\n* Pregnancy in last 12 months\n* History of kidney disease\n* History of liver disease\n* History of metabolic disorder\n* History of some cancers\n* Tobacco use in past 6 months\n* Use of oral or IV antibiotics in past month\n* Use of herbal supplement in past month"}, 'identificationModule': {'nctId': 'NCT01122160', 'briefTitle': 'Gastric pH and Anthocyanin Absorption', 'organization': {'class': 'FED', 'fullName': 'USDA Beltsville Human Nutrition Research Center'}, 'officialTitle': 'Gastric pH as a Possible Determinant of Anthocyanin Absorption', 'orgStudyIdInfo': {'id': '2010-069'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Placebo with berries (blackberries + strawberries)', 'interventionNames': ['Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'omeprazole', 'description': 'Prilosec (omeprazole) 20.6 mg tablet with berries (blackberries + strawberries)', 'interventionNames': ['Drug: omeprazole']}], 'interventions': [{'name': 'omeprazole', 'type': 'DRUG', 'description': 'omeprazole 20.6 mg tablet with berries (blackberries + strawberries)', 'armGroupLabels': ['omeprazole']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Placebo with berries (blackberries + strawberries)', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20705', 'city': 'Beltsville', 'state': 'Maryland', 'country': 'United States', 'facility': "USDA's Beltsville Human Nutrition Research Center", 'geoPoint': {'lat': 39.03483, 'lon': -76.90747}}], 'overallOfficials': [{'name': 'Beverly Clevidence, Ph. D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'USDA Beltsville Human Nutrition Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'USDA Beltsville Human Nutrition Research Center', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Physiologist', 'investigatorFullName': 'Janet Novotny', 'investigatorAffiliation': 'USDA Beltsville Human Nutrition Research Center'}}}}