Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2026-01-02 @ 6:44 AM
Study NCT ID:
NCT02831803
Status:
COMPLETED
Last Update Posted:
2018-08-01
First Post:
2016-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nuts and Extra Virgin Olive Oil Pilot Study
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-30', 'studyFirstSubmitDate': '2016-07-11', 'studyFirstSubmitQcDate': '2016-07-11', 'lastUpdatePostDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retention of study participants', 'timeFrame': '8 weeks', 'description': 'To estimate retention (measured by number attending the 8 week closeout visit) of men and women being treated for hypertension in the 8 week study.'}, {'measure': 'Adherence to consuming walnuts and EVOO', 'timeFrame': '8 weeks', 'description': 'To assess adherence to consuming the nut and oil supplements (measured by daily diary of supplement intake) over the course of the study.'}], 'secondaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': '8 weeks', 'description': 'To estimate the variability of blood pressure in men and women participating in the study'}, {'measure': 'Weight', 'timeFrame': '8 weeks', 'description': 'To estimate the variability of weight in men and women participating in the study'}, {'measure': 'HDL cholesterol', 'timeFrame': '8 weeks', 'description': 'To estimate the variability of HDL cholesterol in men and women participating in the study'}, {'measure': 'Adverse events', 'timeFrame': '8 weeks', 'description': 'To document the types and the rates of adverse events associated with the supplements.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'This study is designed to test the feasibility of asking older adults with high blood pressure to supplement their daily diets with walnuts and extra-virgin olive oil.', 'detailedDescription': 'Even though cardiovascular disease (CVD) continues to be the leading cause of death in the United States, Americans have yet to widely adopt evidence-based dietary modifications necessary to reduce CVD risk factors. Encouraging evidence from the Prevención con Dieta Mediterránea (PREDIMED) trial indicates that adding olive oil and nuts to the diets of older adults in Spain substantially impacted CVD risk factors and events.\n\nA large trial testing EVOO and nuts in a U.S. population is needed to determine if supplementing with EVOO and nuts can reduce risk of cardiovascular events and mortality in adults living in the U.S. Prior to launching a large trial, it is important to assess whether adults 55 and older would be interested in participating in a supplementation trial such as PREDIMED. Additionally, it is important to assess if they are willing to consume the nuts and EVOO and attend study related-data collection visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being treated for hypertension-defined by being prescribed at least one hypertension medication; willing to comply with study visits, as outlined in the protocol; able to read and speak English; no allergies or hypersensitivities to olive oil or nuts; ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Plans to move from the study area in the next 8 weeks; dementia that is medically documented or suspected; homebound for medical reasons; cancer diagnosis and/or treatment in the last 3 years.'}, 'identificationModule': {'nctId': 'NCT02831803', 'briefTitle': 'Nuts and Extra Virgin Olive Oil Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'A Pilot Study to Evaluate the Feasibility of Walnut and Extra Virgin Olive Oil Supplementation in Older Adults Being Treated for Hypertension', 'orgStudyIdInfo': {'id': 'IRB00028877'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'All participants will receive an 8-week supply of walnuts and Extra Virgin Olive Oil (EVOO). Study supplements will consist of 28 gm of walnuts and 32 gm of EVOO per day. Participants will be instructed how to consume the proper amount of walnuts and EVOO and to report their consumption using a compliance diary. The walnuts are pre-packaged in daily servings (one 28 g packet per day) and measuring spoons will be provided with the olive oil to assist participants in consuming it appropriately. Participants will also receive recipes and other written information that will assist them in incorporating both the nuts and olive oil into their existing dietary patterns.', 'interventionNames': ['Dietary Supplement: Walnuts', 'Dietary Supplement: Extra Virgin Olive Oil']}], 'interventions': [{'name': 'Walnuts', 'type': 'DIETARY_SUPPLEMENT', 'description': '28 gm/day in single-serve package', 'armGroupLabels': ['Intervention']}, {'name': 'Extra Virgin Olive Oil', 'type': 'DIETARY_SUPPLEMENT', 'description': '32 gm/day provided in 3, 34 ounce bottles', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mara Z Vitolins, DrPH MPH RDN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'California Walnut Growers Association', 'class': 'UNKNOWN'}, {'name': 'C.H.O. American, Natural and Organic Olive Oil Producer Association', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}