Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-02-28 @ 10:51 PM
Study NCT ID:
NCT01876394
Status:
UNKNOWN
Last Update Posted:
2016-03-10
First Post:
2013-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Dietary Fats on Vascular Parameters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074263', 'term': 'Coconut Oil'}, {'id': 'D000074262', 'term': 'Rapeseed Oil'}, {'id': 'C000715327', 'term': 'Salvia hispanica seed extract'}, {'id': 'D002079', 'term': 'Butter'}], 'ancestors': [{'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-09', 'studyFirstSubmitDate': '2013-06-09', 'studyFirstSubmitQcDate': '2013-06-09', 'lastUpdatePostDateStruct': {'date': '2016-03-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare 5 different dietary fat sources in a liquid meal on postprandial changes in augmentation index (AIx)', 'timeFrame': '5 separate mornings, measurements taken at baseline and at 60, 120 and 180 minutes'}], 'secondaryOutcomes': [{'measure': 'To investigate whether these dietary fat sources will result in blood pressure changes and a differential glycemic response', 'timeFrame': '5 separate mornings, blood pressure measurements will be taken at baseline, 60, 120 and 180 minutes. Blood samples will be taken at baseline 15, 30, 45, 60, 90 and 120 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Healthy', 'Arterial Stiffness', 'Blood Pressure', 'Blood Glucose', 'Vascular Function'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to examine the effect of consuming 50g of fat from 5 different sources (coconut, canola, grapeseed, chia, and butter) on arterial stiffness, blood pressure and blood glucose levels. It is hypothesized that butter will have the most detrimental effect on acute vascular function. Canola, grapeseed and chia oil with their decreased content of SFA are hypothesized to impair vascular function to a lesser extent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* Age 18-65 years\n* BMI \\< 30 kg/m2\n* Brachial systolic blood pressure ≤ 140 mmHg\n* Brachial diastolic blood pressure ≤ 90 mmHg\n\nExclusion Criteria:\n\n* Women of childbearing age must not be pregnant or breastfeeding at the time of the study\n* BMI \\>35kg/m2\n* Hypertensive as defined by brachial SBP \\>140mmHg and/or DBP \\>90mmHg\n* Sensitivity to the study product or its sources\n* Presence of chronic conditions or illnesses\n* Having any gastrointestinal complication or condition\n* Chronic use of dietary supplements that alter fat absorption'}, 'identificationModule': {'nctId': 'NCT01876394', 'acronym': 'COIL', 'briefTitle': 'Comparison of Dietary Fats on Vascular Parameters', 'organization': {'class': 'OTHER', 'fullName': 'Unity Health Toronto'}, 'officialTitle': 'Acute Effects of Dietary Fats on Postprandial Vascular Function in Healthy Individuals: Pilot Double Blind, Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': 'COIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Coconut oil', 'interventionNames': ['Other: Coconut Oil', 'Other: Canola Oil', 'Other: Grapeseed Oil', 'Other: Chia Oil', 'Other: Butter']}, {'type': 'EXPERIMENTAL', 'label': 'Canola oil', 'interventionNames': ['Other: Coconut Oil', 'Other: Canola Oil', 'Other: Grapeseed Oil', 'Other: Chia Oil', 'Other: Butter']}, {'type': 'EXPERIMENTAL', 'label': 'Grapeseed oil', 'interventionNames': ['Other: Coconut Oil', 'Other: Canola Oil', 'Other: Grapeseed Oil', 'Other: Chia Oil', 'Other: Butter']}, {'type': 'EXPERIMENTAL', 'label': 'Chia oil', 'interventionNames': ['Other: Coconut Oil', 'Other: Canola Oil', 'Other: Grapeseed Oil', 'Other: Chia Oil', 'Other: Butter']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Butter', 'interventionNames': ['Other: Coconut Oil', 'Other: Canola Oil', 'Other: Grapeseed Oil', 'Other: Chia Oil', 'Other: Butter']}], 'interventions': [{'name': 'Coconut Oil', 'type': 'OTHER', 'description': 'Shake with 50 g Coconut oil', 'armGroupLabels': ['Butter', 'Canola oil', 'Chia oil', 'Coconut oil', 'Grapeseed oil']}, {'name': 'Canola Oil', 'type': 'OTHER', 'description': 'Shake with 50 g Canola oil', 'armGroupLabels': ['Butter', 'Canola oil', 'Chia oil', 'Coconut oil', 'Grapeseed oil']}, {'name': 'Grapeseed Oil', 'type': 'OTHER', 'description': 'Shake with 50 g Grapeseed oil', 'armGroupLabels': ['Butter', 'Canola oil', 'Chia oil', 'Coconut oil', 'Grapeseed oil']}, {'name': 'Chia Oil', 'type': 'OTHER', 'description': 'Shake with 50 g Chia oil', 'armGroupLabels': ['Butter', 'Canola oil', 'Chia oil', 'Coconut oil', 'Grapeseed oil']}, {'name': 'Butter', 'type': 'OTHER', 'description': 'Shake with 50 g Butter', 'armGroupLabels': ['Butter', 'Canola oil', 'Chia oil', 'Coconut oil', 'Grapeseed oil']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': "Risk Factor Modification Centre, St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Thanh Ho, BSc', 'role': 'CONTACT', 'email': 'hoho@smh.ca', 'phone': '416-864-6060', 'phoneExt': '2087'}], 'overallOfficials': [{'name': 'Vuksan Vladimir, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Risk Factor Modification Centre - St. Michael's Hospital"}, {'name': 'Alexandra Jenkins (Co-investigator), PhD, RD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unity Health Toronto'}, {'name': 'William Watson (Qualified investigator), MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unity Health Toronto'}, {'name': 'Elena Jovanovski (Co-investigator), MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unity Health Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unity Health Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}