Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 4:59 AM
Study NCT ID:
NCT03515460
Status:
COMPLETED
Last Update Posted:
2024-03-26
First Post:
2018-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Effects of Oral Carbohydrate and Fat Loads on Systemic Microvascular Endothelial Function in Healthy Individuals.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-24', 'studyFirstSubmitDate': '2018-04-20', 'studyFirstSubmitQcDate': '2018-05-02', 'lastUpdatePostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'endothelial-dependent microvascular function', 'timeFrame': 'one day', 'description': 'alterations in skin microvascular conductance using laser-based methods'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vascular endothelial function', 'systemic microvascular reactivity', 'dysglycemia', 'dyslipidemia'], 'conditions': ['Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'The present study was designed to evaluate vascular endothelial dysfunction resulting from the oral ingestion of high loads of sugar and fat meals in healthy individuals.', 'detailedDescription': 'The chronic and elevated consumption of fat and carbohydrates is associated with the initiation and the progression of cardiovascular and metabolic diseases, including diabetes, obesity and metabolic syndrome. In general, chronic diseases are related to underlying modifiable cardiovascular risk factors, including high blood pressure, high plasma lipids and glucose, physical inactivity, overweight and obesity, as well as smoking habits.\n\nVascular endothelial dysfunction is one of the earliest findings in the pathophysiology of atherosclerosis and also an important predictor of cardiovascular events. Moreover, it has already been demonstrated that acute oral ingestion of high loads of sugar and fat meals induces transient vascular endothelial dysfunction, which over time could lead to cardiovascular disease.\n\nThus, the present study aimed at investigating the individual contributions of sugar and fat ingestion on systemic microvascular endothelial reactivity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy individuals presenting body mass index between 18.5 e 24.9 kg/m2\n\nExclusion Criteria:\n\n* dysglycemia and dyslipidemia\n* overweight and obesity'}, 'identificationModule': {'nctId': 'NCT03515460', 'briefTitle': 'Acute Effects of Oral Carbohydrate and Fat Loads on Systemic Microvascular Endothelial Function in Healthy Individuals.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Institute of Cardiology, Laranjeiras, Brazil'}, 'officialTitle': 'Acute Effects of Standardized Oral Carbohydrate and Fat Loads, and the Association of Carbohydrate and Fat Loads, on Systemic Microvascular Endothelial Function in Healthy Individuals.', 'orgStudyIdInfo': {'id': 'CAAE 86854318.8.0000.5272'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sugar oral load', 'description': 'oral ingestion of a high carbohydrate meal', 'interventionNames': ['Other: sugar oral load']}, {'type': 'EXPERIMENTAL', 'label': 'fat oral load', 'description': 'oral ingestion of a high fat meal', 'interventionNames': ['Other: fat oral load']}, {'type': 'EXPERIMENTAL', 'label': 'sugar and fat oral loads', 'description': 'oral ingestion of a high carbohydrate and fat meal', 'interventionNames': ['Other: sugar and fat oral load']}], 'interventions': [{'name': 'sugar oral load', 'type': 'OTHER', 'otherNames': ['dietary intervention'], 'description': 'The individuals will receive a sugar oral load (high sugar meal)', 'armGroupLabels': ['sugar oral load']}, {'name': 'fat oral load', 'type': 'OTHER', 'otherNames': ['dietary intervention'], 'description': 'The individuals will a receive fat oral load (high fat meal)', 'armGroupLabels': ['fat oral load']}, {'name': 'sugar and fat oral load', 'type': 'OTHER', 'otherNames': ['dietary intervention'], 'description': 'The individuals will a receive sugar and fat oral load (high sugar and high fat meal)', 'armGroupLabels': ['sugar and fat oral loads']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22240-006', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'National Institute of Cardiology, Ministry of Health, Brazil', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}], 'overallOfficials': [{'name': 'EDUARDO TIBIRICA, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Cardiology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Cardiology, Laranjeiras, Brazil', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Researcher, MD, PhD', 'investigatorFullName': 'Eduardo Tibirica, MD, PhD', 'investigatorAffiliation': 'National Institute of Cardiology, Laranjeiras, Brazil'}}}}