Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2026-01-09 @ 10:33 AM
Study NCT ID:
NCT05116150
Status:
COMPLETED
Last Update Posted:
2021-11-10
First Post:
2021-10-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Combined Grape Seed Extract and L-citrulline Supplementation on Hemodynamic Responses in Young Males
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D056604', 'term': 'Grape Seed Extract'}], 'ancestors': [{'id': 'D010936', 'term': 'Plant Extracts'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-01', 'studyFirstSubmitDate': '2021-10-19', 'studyFirstSubmitQcDate': '2021-11-01', 'lastUpdatePostDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic blood pressure (mmHg)', 'timeFrame': '7 days', 'description': 'by sphygmomanometer'}, {'measure': 'Diastolic blood pressure (mmHg)', 'timeFrame': '7 days', 'description': 'by sphygmomanometer'}, {'measure': 'Mean arterial pressure (mmHg)', 'timeFrame': '7 days', 'description': 'calculated (MAP = (SBP-DBP)/3 + DBP'}, {'measure': 'Heart rate (bpm)', 'timeFrame': '7 days', 'description': 'measured using Physio Flow (non-invasive device)'}, {'measure': 'Stroke volume (ml)', 'timeFrame': '7 days', 'description': 'measured using Physio Flow (non-invasive device)'}, {'measure': 'Cardiac output (l/min)', 'timeFrame': '7 days', 'description': 'calculated: HR (bpm) x SV (ml)'}, {'measure': 'Total vascular conductance (ml/min/mmHg)', 'timeFrame': '7 days', 'description': 'calculated: CO (ml/min) / MAP (mmHg)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dietary Supplementation']}, 'descriptionModule': {'briefSummary': 'This study was to examine the additive benefits with combined grape seed extract (GSE) and L-citrulline supplementation on hemodynamic responses to dynamic exercise, 11 young, healthy males were recruited for this study.', 'detailedDescription': 'The investigators aimed the additive effects of combined grape seed extract (GSE) and L-citrulline supplementation on hemodynamic responses to dynamic exercise, 11 young, healthy males were recruited for this study. Effects of 7 days of combined GSE with L-citrulline supplementation on systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP), cardiac output (CO), total vascular conductance (TVC), and oxygen consumption (O2) were examined at rest and during cycling exercise.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy males\n\nExclusion Criteria:\n\n* cardiovascular and/or pulmonary disease, musculoskeletal disorders, or medications that prevent the safe completion of the exercise protocol'}, 'identificationModule': {'nctId': 'NCT05116150', 'briefTitle': 'Effects of Combined Grape Seed Extract and L-citrulline Supplementation on Hemodynamic Responses in Young Males', 'organization': {'class': 'OTHER', 'fullName': 'California Baptist University'}, 'officialTitle': 'Effects of Combined Grape Seed Extract and L-citrulline Supplementation on Hemodynamic Responses in Young Males', 'orgStudyIdInfo': {'id': '112-1819 EXP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Randomized double blind grape seed extract design', 'description': 'Grape see extract', 'interventionNames': ['Dietary Supplement: Grape seed extract', 'Dietary Supplement: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Randomized double blind placebo design', 'description': 'Placebo', 'interventionNames': ['Dietary Supplement: Grape seed extract', 'Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Grape seed extract', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Effects of 7 days of combined GSE with L-citrulline supplementation on hemodynamic responses at rest and during cycling exercise.', 'armGroupLabels': ['Randomized double blind grape seed extract design', 'Randomized double blind placebo design']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Effects of 7 days of placebo supplementation on hemodynamic responses at rest and during cycling exercise.', 'armGroupLabels': ['Randomized double blind grape seed extract design', 'Randomized double blind placebo design']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92504', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'California Baptist University', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}], 'overallOfficials': [{'name': 'Jong-Kyung Kim, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'California Baptist University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'California Baptist University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}