Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-25 @ 4:45 PM
Study NCT ID:
NCT03528603
Status:
COMPLETED
Last Update Posted:
2024-06-24
First Post:
2018-03-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acute Assessment of Platelet Reactivity After the Intake of Oleocanthal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Extra Virgin Olive Oils will be stored and provided to the study investigators in coded single serving bottles'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'controlled, randomized, double-blind, with 2 interventions'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-20', 'studyFirstSubmitDate': '2018-03-27', 'studyFirstSubmitQcDate': '2018-05-04', 'lastUpdatePostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Influence of Oleocanthal-rich EVOO intake on Collagen-induced platelet aggregometry', 'timeFrame': 'baseline, 2, 4 and 6 hours', 'description': 'Optical platelet aggregometry will be used to measure platelet aggregation. The percent maximal platelet aggregation will be measured. A reduction in maximal aggregation 2, 4 or 6 hours post EVOO intake compared to baseline will represent a reduction in platelet aggregation.'}], 'secondaryOutcomes': [{'measure': 'Influence of Oleocanthal-rich EVOO intake on Adenosine Diphosphate-induced platelet aggregometry', 'timeFrame': 'baseline, 2, 4 and 6 hours', 'description': 'Optical platelet aggregometry will be used to measure platelet aggregation. The percent maximal platelet aggregation will be measured. A reduction in maximal aggregation 2, 4 or 6 hours post EVOO intake compared to baseline will represent a reduction in platelet aggregation.'}, {'measure': 'Influence of Oleocanthal-rich EVOO intake on Arachidonic Acid-induced platelet aggregometry', 'timeFrame': 'baseline, 2, 4 and 6 hours', 'description': 'Optical platelet aggregometry will be used to measure platelet aggregation. The percent maximal platelet aggregation will be measured. A reduction in maximal aggregation 2, 4 or 6 hours post EVOO intake compared to baseline will represent a reduction in platelet aggregation.'}, {'measure': 'Influence of Oleocanthal-rich EVOO intake on Platelet-derived oxylipins', 'timeFrame': 'baseline, 2, 4 and 6 hours', 'description': 'Oxylipin profile will be conducted from the activated platelet supernatant ultra high-performance liquid chromatography-mass spectrometry (HPLC) is used to measure levels of oxylipin. HPLC area under the peak will be measured.'}, {'measure': 'Influence of Oleocanthal-rich EVOO intake on Metabolomics', 'timeFrame': 'baseline, 2, 4 and 6 hours', 'description': 'Untargeted metabolomics will be performed to assess the relationship between platelet response and the presence of circulating plasma metabolites.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['platelet, aggregation, phenolic, olive oil, oleocanthal'], 'conditions': ['Platelet Aggregation', 'Nutritional and Metabolic Disease', 'Cardiovascular Diseases']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://studypages.com/s/study-of-the-effects-of-extra-virgin-olive-oil-polyphenols-on-cardiovascular-health-162282/', 'label': 'Learn more or sign up for the study here!'}]}, 'descriptionModule': {'briefSummary': 'The investigators have previously observed a reduced level of platelet aggregation 2 hours after healthy male individuals were asked to drink extra virgin olive oil (EVOO) that provided a higher level of one specific phenolic known as oleocanthal. This study will help the investigators further determine the effects of oleocanthal-rich EVOO intake on platelet function at 2, 4 and 6 hours after intake with food compared to platelet function in the morning after an overnight fast.', 'detailedDescription': 'Fifty adult male volunteers will be asked to participate in one of two study trials that will be randomized double-blind controlled crossover trials with 2 study visits. The participants will arrive to the facility after an overnight fast, and will be asked to consume their assigned EVOO either without (trial 1) or with (trial 2) a standardized low-phenolic food (such as rice, pasta or mashed potatoes) with 40 mL of one of 2 EVOOs that are matched for their total phenolic content, but with one oil containing oleocanthal, and one with very low levels of oleocanthal. At zero, two, 4 and 6 hours after EVOO intake a blood sample will be collected for the assessment of collagen- ADP-, and AA-induced platelet aggregation, as well as an untargeted metabolomics profile.\n\nAs an assessment of phenotypic stability, a subset of individuals (n=5 per trial) that have exhibit either low or high platelet responses, will be asked to repeat the above study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Trials 1 and 2: Male; Trial 3: Male and Female\n* 20-45 years old\n* For females, a regular 25-30-day menstrual cycle\n* Subject is willing and able to comply with the study protocols\n* Subject is willing to drink 40 mL (approximately 2 tablespoons) of olive oil\n* BMI 18.5 - 30 kg/m2\n* Weight ≥ 110 pounds\n\nExclusion Criteria:\n\n* Adults who are not able to consent\n* BMI ≥ 31 kg/m2\n* Under current medical supervision\n* 1 ug/ml and 3 ug/ml collagen screening maximal platelet aggregatory response of \\< 65%.\n* Platelet number or mean platelet values that are outside of the normal reference range as indicated on a complete blood cell count report from the UCD Med Center\n* Current diagnosis of anemia; or a screening hemoglobin and hematocrit that is less than the normal reference range.\n* Self-reported daily use of drugs that are known to affect platelet function, such as aspirin, Excedrin, and NSAIDS\n* Females using hormonal contraception\n* Ibuprofen intolerance or allergy\n* Those with a bleeding disorder\n* Non-English speaking\n* Allergy to olives or olive oil\n* Vegetarian, Vegan, food faddists, individuals using non-traditional diets, or on a weight loss diet.\n* A history of cardiovascular disease, stroke, cancer, renal, hepatic, or thyroid disease, GI tract disorders, previous GI surgery\n* Currently taking prescription drugs or supplements\n* Indications of substance or alcohol abuse within the last 3 years\n* Not willing to stop any supplement use, including herbal, plant or botanical, fish oil, oil supplements for six weeks prior to study enrollment.\n* Not willing to refrain from olive oil consumption for 4 weeks prior to study enrollment, and throughout study enrollment\n* Self-reported malabsorption (e.g. difficulty digesting or absorbing nutrients from food, potentially leading to bloating, cramping or gas)\n* Current enrollee in a clinical research study.\n* Individuals with blood clotting or platelet defect disorders'}, 'identificationModule': {'nctId': 'NCT03528603', 'briefTitle': 'Acute Assessment of Platelet Reactivity After the Intake of Oleocanthal', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Acute Assessment of Platelet Reactivity After the Intake of Oleocanthal From Extra Virgin Olive Oil in the Fasted and Fed Condition', 'orgStudyIdInfo': {'id': '1158686'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oleocanthal-Rich Extra Virgin Olive Oil', 'description': 'Extra Virgin Olive Oil that is high in the phenolic oleocanthal, but contains similar amounts of total phenolics as the Oleocanthal-Low Extra Virgin Olive Oil', 'interventionNames': ['Other: Oleocanthal-Rich Extra Virgin Olive Oil', 'Other: Oleocanthal-low Extra Virgin Olive Oil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Oleocanthal-Low Extra Virgin Olive Oil', 'description': 'Extra Virgin Olive Oil that is low in the phenolic oleocanthal, but contains similar amounts of total phenolics as the Oleocanthal-Rich Extra Virgin Olive Oil', 'interventionNames': ['Other: Oleocanthal-Rich Extra Virgin Olive Oil', 'Other: Oleocanthal-low Extra Virgin Olive Oil']}], 'interventions': [{'name': 'Oleocanthal-Rich Extra Virgin Olive Oil', 'type': 'OTHER', 'description': 'Extra Virgin Olive Oil that contains a high level of the phenolic oleocanthal', 'armGroupLabels': ['Oleocanthal-Low Extra Virgin Olive Oil', 'Oleocanthal-Rich Extra Virgin Olive Oil']}, {'name': 'Oleocanthal-low Extra Virgin Olive Oil', 'type': 'OTHER', 'description': 'Extra Virgin Olive Oil that contains a low level of the phenolic oleocanthal', 'armGroupLabels': ['Oleocanthal-Low Extra Virgin Olive Oil', 'Oleocanthal-Rich Extra Virgin Olive Oil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95616', 'city': 'Davis', 'state': 'California', 'country': 'United States', 'facility': 'Department of Nutrition', 'geoPoint': {'lat': 38.54491, 'lon': -121.74052}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}