Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-27 @ 11:12 PM
Study NCT ID:
NCT04389060
Status:
COMPLETED
Last Update Posted:
2020-05-15
First Post:
2020-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Acute Dietary Supplementation With Grape Seed Extract on Aortic Stiffness, Arterial Pressure, and Blood Vessel Dilation in Collegiate Obese Individuals at Rest
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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'], 'maskingDescription': 'Double blind, cross-over design'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-11', 'studyFirstSubmitDate': '2020-05-08', 'studyFirstSubmitQcDate': '2020-05-11', 'lastUpdatePostDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in heart rate', 'timeFrame': '2 hours after each supplementation', 'description': 'beats per minute'}, {'measure': 'change in stroke volume', 'timeFrame': '2 hours after each supplementation', 'description': 'volume per stroke'}, {'measure': 'change in cardiac output', 'timeFrame': '2 hours after each supplementation', 'description': 'total volume for a minute'}, {'measure': 'change in systolic blood pressure', 'timeFrame': '2 hours after each supplementation', 'description': 'pressure exerted during contraction'}, {'measure': 'change in diastolic blood pressure', 'timeFrame': '2 hours after each supplementation', 'description': 'pressure exerted during relaxation'}, {'measure': 'change in mean arterial pressure', 'timeFrame': '2 hours after each supplementation', 'description': 'One reported pressure (systolic blood pressure-diastolic blood pressure)/3 + diastolic blood pressure'}, {'measure': 'change in total peripheral resistance', 'timeFrame': '2 hours after each supplementation', 'description': 'One reported value (mean arterial pressure/cardiac output)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'This study investigated if elevated BP and aortic stiffness characterized in obese individuals are attenuated following acute grape seed extract supplementation. It is hypothesized that acute dietary supplementation with grape seed extract attenuates aortic stiffness, systolic blood pressure, diastolic blood pressure, mean arterial pressure, and total peripheral resistance and these effects are partially due to reductions in peripheral vasoconstriction', 'detailedDescription': 'Twenty men (obese = 10; normal body weight (NBW) = 10) participated in this study. Effects of placebo (PL: 600 mg) and GSE (600 mg) on systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), stroke volume (SV), cardiac output (Q), total peripheral resistance (TPR), and AoS were compared 2 h after ingestion of GSE or PL on different days, one week apart. Arterial blood pressure was measured using a sphygmomanometer from a brachial artery at the level of the heart on chair. HR and SV were continuously measured using a non-invasive device (Physio Flow). CO was calculated by HR X SV. TPR was calculated by MAP/CO.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '29 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obesity: body mass index (\\>30), Normal body weight: body mass index (25-29)\n\nExclusion Criteria:\n\n* cardiovascular diseases or consume any antihypertensive medication or supplementation that can affect blood pressure or aortic stiffness'}, 'identificationModule': {'nctId': 'NCT04389060', 'briefTitle': 'Effect of Acute Dietary Supplementation With Grape Seed Extract on Aortic Stiffness, Arterial Pressure, and Blood Vessel Dilation in Collegiate Obese Individuals at Rest', 'organization': {'class': 'OTHER', 'fullName': 'California Baptist University'}, 'officialTitle': 'Effects of Acute Grape Seed Extract Supplementation on Hemodynamics in Obese Males', 'orgStudyIdInfo': {'id': '081-1819-EXP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'GSE group', 'description': 'Subjects took a single dose of 600 mg GSE in capsule form through ingestion 2 hours prior to testing', 'interventionNames': ['Dietary Supplement: Grape seed extract']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Subjects took a single dose of 600 mg starch in capsule form through ingestion 2 hours prior to testing', 'interventionNames': ['Dietary Supplement: Grape seed extract']}], 'interventions': [{'name': 'Grape seed extract', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Two capsule grape seed extract (total 600 mg)', 'armGroupLabels': ['GSE group', 'Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92504', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'California Baptist University', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'California Baptist University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jong-Kyung Kim', 'investigatorAffiliation': 'California Baptist University'}}}}