Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT01009658
Status:
COMPLETED
Last Update Posted:
2015-03-26
First Post:
2009-11-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MSG and Gastrointestinal Motility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012970', 'term': 'Sodium Glutamate'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D018698', 'term': 'Glutamic Acid'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'lastUpdateSubmitDate': '2015-03-25', 'studyFirstSubmitDate': '2009-11-06', 'studyFirstSubmitQcDate': '2009-11-06', 'lastUpdatePostDateStruct': {'date': '2015-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastric emptying', 'timeFrame': '0-5 hours', 'description': 'half emptying time'}]}, 'conditionsModule': {'keywords': ['Gastrointestinal motility', 'Gastroesophageal reflux', 'Gastric emptying', 'Sodium glutamate', 'Lower esophageal sphincter'], 'conditions': ['Gastroesophageal Reflux']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to clarify the physiological function of sodium glutamate by measuring its effect on upper GI motility ( gastric emptying).', 'detailedDescription': 'Amino acids such as monosodium glutamate are known to stimulate both endocrine and exocrine secretion. In addition, there is a report that oral intake of glutamate evokes the activation of vagal afferent nerves in the rat. Thus, such amino acids are thought to be influential in the process of digestion and absorption.\n\n. To investigate the effect of monosodium glutamate on gastrointestinal motility, we planned a single-blind randomized study. The participants will take either monosodium glutamate or sodium chloride before the first examination of upper GI motility and the other agent before the second examination. The order of intake will be randomized by the envelope method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects\n* Must not have digestive symptoms\n* Must not eat within six hours of study participation\n\nExclusion Criteria:\n\n* Regular medications for the gastrointestinal tract\n* Previous Helicobacter pylori infection\n* Previous abdominal surgery'}, 'identificationModule': {'nctId': 'NCT01009658', 'briefTitle': 'MSG and Gastrointestinal Motility', 'organization': {'class': 'OTHER', 'fullName': 'Gunma University'}, 'officialTitle': 'Effect of Monosodium Glutamate on Upper Gastrointestinal Tract Motility', 'orgStudyIdInfo': {'id': 'GU-696'}, 'secondaryIdInfos': [{'id': 'GU-CT 696'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MSG first', 'interventionNames': ['Dietary Supplement: Monosodium glutamate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'NaCl first', 'interventionNames': ['Dietary Supplement: Sodium chloride']}], 'interventions': [{'name': 'Monosodium glutamate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral intake of 2.0 g of monosodium glutamate on the examination day and 0.6 g of sodium chloride on the other examination day.', 'armGroupLabels': ['MSG first']}, {'name': 'Sodium chloride', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral intake of 0.6 g of sodium chloride on the examination day and 2.0 g of monosodium glutamate on the other examination day.', 'armGroupLabels': ['NaCl first']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3718511', 'city': 'Maebashi', 'state': 'Gunma', 'country': 'Japan', 'facility': 'Gunma university hospital', 'geoPoint': {'lat': 36.4, 'lon': 139.08333}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gunma University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Hiroko Hosaka', 'investigatorAffiliation': 'Gunma University'}}}}