Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-27 @ 11:33 AM
Study NCT ID:
NCT03716960
Status:
COMPLETED
Last Update Posted:
2018-10-24
First Post:
2018-10-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Pumpkin Seed Oil Supplementation on Cardiovascular Function in Postmenopausal Women.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-22', 'studyFirstSubmitDate': '2018-10-20', 'studyFirstSubmitQcDate': '2018-10-20', 'lastUpdatePostDateStruct': {'date': '2018-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': '6 weeks', 'description': 'Non-invasive measures of brachial and aortic blood pressure'}, {'measure': 'Pressure Wave Reflection', 'timeFrame': '6 weeks', 'description': 'Using the augmentation index'}, {'measure': 'Arterial Stiffness', 'timeFrame': '6 weeks', 'description': 'Using the stiffness index'}, {'measure': 'Heart rate variability', 'timeFrame': '6 weeks', 'description': 'R-R intervals were collected during 6 min using a validated wireless monitor (Polar 800CX; Polar Electro OY, Kempele, Finland) via a chest strap interfaced with a PC. All R-R intervals were inspected for artifacts and premature beats.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Elevated Blood Pressure', 'Hypertension']}, 'referencesModule': {'references': [{'pmid': '31445363', 'type': 'DERIVED', 'citation': 'Wong A, Viola D, Bergen D, Caulfield E, Mehrabani J, Figueroa A. The effects of pumpkin seed oil supplementation on arterial hemodynamics, stiffness and cardiac autonomic function in postmenopausal women. Complement Ther Clin Pract. 2019 Nov;37:23-26. doi: 10.1016/j.ctcp.2019.08.003. Epub 2019 Aug 8.'}]}, 'descriptionModule': {'briefSummary': 'Postmenopausal women have a higher prevalence of cardiovascular (CV) disease than age-match men. Growing evidence from rat studies have demonstrated CV-protective effects of pumpkin seed oil (PSO).\n\nThe investigators hypothesis is that PSO would improve CV health in postmenopausal women.', 'detailedDescription': 'The purpose of the study is to examine the effects of 6 weeks of PSO on arterial and autonomic function in postmenopausal women. Specific aims of the study are to:\n\nTo investigate the extent to which PSO will improve cardiovascular disease risk factors by assessing arterial stiffness, aortic BP and wave reflection, and autonomic function (heart rate variability).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* 45 to 65 years of age\n* At least 1 year after menopause\n* BMI \\<39.9\n* Sedentary or low active (less than 2 hr per wk)\n\nExclusion Criteria:\n\n* known heart disease\n* peripheral vascular disease\n* diabetes, body mass index\n* BMI\\> 40 kg/m2\n* other chronic diseases\n* taking medications (e.g., hormone replacement therapy, beta blockers, calcium channel blockers, antidepressants and stimulants) that could affect the outcome variables\n* smokers\n* history of steady exercise or received exercise training and dietary changes in the last year'}, 'identificationModule': {'nctId': 'NCT03716960', 'briefTitle': 'The Effects of Pumpkin Seed Oil Supplementation on Cardiovascular Function in Postmenopausal Women.', 'organization': {'class': 'OTHER', 'fullName': 'Marymount University'}, 'officialTitle': 'The Effects of Pumpkin Seed Oil Supplementation on Vascular Hemodynamics, Stiffness and Cardiac Autonomic Function in Postmenopausal Women.', 'orgStudyIdInfo': {'id': '321'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pumpkin Seed Oil', 'description': 'This arm involved 6 weeks of PSO consumption. Subject were supplemented with 3 g/day of PSO which was ingested in the form of 1g capsules with each main meal of the day (breakfast, lunch and dinner). Likewise,', 'interventionNames': ['Other: Pumpkin Seed Oil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'This arm involved 6 weeks of placebo consumption. Subject consumed 1 capsule of maltodextrin with each main meal of the day to match the dose and number of capsules ingested daily by the PSO group.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Pumpkin Seed Oil', 'type': 'OTHER', 'description': 'This intervention consisted of 6 weeks of PSO consumption. Subject were supplemented with 3 g/day of PSO which was ingested in the form of 1g capsules with each main meal of the day (breakfast, lunch and dinner).', 'armGroupLabels': ['Pumpkin Seed Oil']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'This intervention consisted of 6 weeks of placebo consumption. Subject consumed 1 capsule of maltodextrin with each main meal of the day to match the dose and number of capsules ingested daily by the PSO group.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22207', 'city': 'Arlington', 'state': 'Virginia', 'country': 'United States', 'facility': 'Marymount University', 'geoPoint': {'lat': 38.88101, 'lon': -77.10428}}], 'overallOfficials': [{'name': 'Alexei Wong, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Marymount University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marymount University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Alexei Wong', 'investigatorAffiliation': 'Marymount University'}}}}