Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2025-12-27 @ 8:40 AM
Study NCT ID:
NCT01928966
Status:
WITHDRAWN
Last Update Posted:
2017-05-30
First Post:
2013-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Pumpkin Seeds on the Dietary Fatty Acid Intake and Blood Pressure in Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Advisor left the university and student moved to a clinical track', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-24', 'studyFirstSubmitDate': '2013-08-21', 'studyFirstSubmitQcDate': '2013-08-21', 'lastUpdatePostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dietary fatty acid intake', 'timeFrame': '12 weeks', 'description': 'The dietary fatty acid intake, specifically monounsaturated and polyunsaturated fatty acids, will be measured three times over the course of a twelve week period to determine if fatty acid intake changed during the intervention.'}, {'measure': 'Blood pressure', 'timeFrame': '12 weeks', 'description': 'Blood pressure will be measured at every meeting to determine if the addition of pumpkin seeds to the diet altered blood pressure.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['dietary fat', 'fat intake', 'blood pressure', 'women', 'phytoestrogen', 'pumpkin seeds', 'cardiovascular disease', 'heart disease', 'secoisolariciresinol', 'monounsaturated fat', 'polyunsaturated fat', 'feeding study'], 'conditions': ['Cardiovascular Disease', 'Blood Pressure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if the inclusion of 1.5 ounces of pumpkin seeds per day in the diet of women will alter dietary fatty acid intake or blood pressure.', 'detailedDescription': 'Cardiovascular disease is the number one cause of morbidity and mortality in United States. Diets high in polyunsaturated and monounsaturated fatty acids have been shown to decrease the risk of cardiovascular disease. Pumpkin seeds are a good source of monounsaturated and polyunsaturated fatty acids. Oil extracted from pumpkin seeds has been shown to lower blood pressure. One purpose of this study is to determine whether eating 1.5 ounces of pumpkin seeds per day will improve polyunsaturated and monounsaturated fatty acid intake in the diet in healthy adult women. Another purpose of this study is to determine whether eating 1.5 ounces of pumpkin seeds a day will lower blood pressure.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* Over the age of 18\n* Able to read, write, and speak English\n* Able to keep a three-day diet diary\n* Willing and able to consume pumpkin seeds\n\nExclusion Criteria:\n\n* Pregnant or planning to become pregnant\n* Allergic to pumpkin seeds\n* High blood pressure\n* Regularly consuming pumpkin seeds (more than 4 times per month)\n* Taking blood pressure medication\n* Liver disease\n* Kidney disease\n* Gastrointestinal disease\n* History of bariatric surgery\n* History of a major cardiovascular event\n* Heart disease\n* Currently undergoing cancer treatment (except nonmelanoma cancer)\n* Following a weight control diet\n* Following a disease specific diet\n* Following a vegan diet\n* Have a diagnosed eating disorder'}, 'identificationModule': {'nctId': 'NCT01928966', 'acronym': 'PSS1', 'briefTitle': 'Effect of Pumpkin Seeds on the Dietary Fatty Acid Intake and Blood Pressure in Women', 'organization': {'class': 'OTHER', 'fullName': "Texas Woman's University"}, 'officialTitle': 'Effect of Pumpkin Seeds on the Dietary Fatty Acid Intake and Blood Pressure in Women', 'orgStudyIdInfo': {'id': 'TWU-1PS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group I - Pumpkin Seeds', 'description': 'First four weeks of study: consume perceived normal diet; Second four weeks of study: receive 1.5 ounces of pumpkin seeds per day for consumption; Third four weeks of the study: consume their perceived normal diet.', 'interventionNames': ['Other: Pumpkin Seeds']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II - Pumpkin Seeds', 'description': 'First four weeks of study: consume perceived normal diet; Second four week period: consume perceived normal diet; Third four week period: receive 1.5 ounces of pumpkin seeds per day for consumption.', 'interventionNames': ['Other: Pumpkin Seeds']}], 'interventions': [{'name': 'Pumpkin Seeds', 'type': 'OTHER', 'description': 'Participants will be asked to consume 1.5 ounces of raw, unsalted pumpkin seeds per day. The 1.5 ounces will be split in to two servings (each 0.75 ounces).', 'armGroupLabels': ['Group I - Pumpkin Seeds', 'Group II - Pumpkin Seeds']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Woman's University", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'John D Radcliffe, PhD', 'role': 'STUDY_CHAIR', 'affiliation': "Texas Woman's University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The study was stopped before data collection began - no data to share.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Texas Woman's University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}