Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-02-28 @ 7:11 PM
Study NCT ID:
NCT04998695
Status:
COMPLETED
Last Update Posted:
2021-08-16
First Post:
2021-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Health Effects of Consuming Olive Pomace Oil
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074242', 'term': 'Sunflower Oil'}], 'ancestors': [{'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Oils were provided in unlabelled bottles (only differed in the colors of stoppers)'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'After a 3-week run-in, healthy and at risk (hypercholesterolemic) volunteers were randomly allocated to one of each arm.\n\nEach intervention stage lasted 4 weeks and was separated by a 3-week wash-out.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-09', 'studyFirstSubmitDate': '2021-08-04', 'studyFirstSubmitQcDate': '2021-08-04', 'lastUpdatePostDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood lipids', 'timeFrame': '4 weeks', 'description': 'Reduction of total or LDL-cholesterol levels or triglycerides in at risk (hypercholesterolemic) subjects. No effect on blood lipids expected in healthy (normocholesterolemic) volunteers'}], 'secondaryOutcomes': [{'measure': 'Endothelial function', 'timeFrame': '4 weeks', 'description': 'Modification in the levels of selectins, adhesion molecules, or eNOS levels in volunteers'}, {'measure': 'Blood pressure', 'timeFrame': '4 weeks', 'description': 'Changes in systolic/diastolic blood pressure in volunteers'}, {'measure': 'Glucose homeostasis', 'timeFrame': '4 weeks', 'description': 'Modification of fasting blood glucose or insulin levels, decrease in glycosylated hemoglobin (Hb1Ac), homeostasis model assessment (HOMA) of insulin resistance (HOMA-IR) or beta-cell function (HOMA-beta)'}, {'measure': 'Inflammation', 'timeFrame': '4 weeks', 'description': 'Concentration of serum pro-inflammatory cytokines/C-Reactive protein (CRP) modified in participants'}, {'measure': 'Oxidative status', 'timeFrame': '4 weeks', 'description': 'Modification of serum antioxidant capacity (FRAP, ABTS, ORAC, expressed as nM Trolox equivalents)'}, {'measure': 'Lipid oxidation markers', 'timeFrame': '4 weeks', 'description': 'Concentration of biomarkers of lipid oxidation (MDA and/or LDLox) in serum modified'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Olive pomace oil', 'Lipaemia', 'Glucose homeostasis', 'Inflammation', 'Oxidative stress biomarkers', 'Endothelial function'], 'conditions': ['Healthy', 'Hypercholesterolemia']}, 'descriptionModule': {'briefSummary': 'Healthy and at risk (hypercholesterolemic) subjects consumed during 4 weeks 45 g/d of either olive pomace oil (OPO) or sunflower oil (SO) as the only dietary fat in a randomized, crossover trial. The effects on blood lipids, glucose homeostasis, endothelial function, inflammatory cytokines, oxidative stress biomarkers and anthropometry were measured.', 'detailedDescription': "The intervention aimed at studying the potential health effects of olive pomace oil in comparison with sunflower oil.\n\nAfter a 3-weeks run-in, 31 healthy (normocholesterolemic) and 37 hypercholesterolemic subjects were randomized to consume either OPO or SO (45 g/d) during 4 weeks, followed by a 3-week wash-out during which volunteers consumed the same amount of corn oil. During all the study, other dietary sources of fat (oil, nuts, butter, etc.) were restricted. Food intake was monitored by 3-d food records in each intervention stage and volunteers were instructed to maintain their normal physical and dietary habits (except for the changes in the consumption of other oils and fats).\n\nAt the beginning and end of each intervention stage, blood and urine samples were obtained, and blood pressure and anthropometric measurements were performed. A complete batch of analysis were performed, including serum lipids, endothelial function (endothelial nitric oxide synthase (eNOS), vascular (VCAM-1) and intercellular (ICAM-1) cell adhesion molecules, E- and P-selectins), inflammatory and anti-inflammatory cytokines, glucose homeostasis/insulin resistance, antioxidant status and biomarkers of lipid oxidation (malondialdehyde (MDA), LDLox, ferric reducing antioxidant power (FRAP), oxygen radical absorbance capacity (ORAC), ABTS (2,2'-azino-bis(3-ethylbenzothiazoline-6-sulfonic acid) quenching capacity) and anthropometry, along with determination of incretins, adipokines, and other clinical and hematological parameters."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy volunteers (Total cholesterol \\< 200 mg/dL; LDL-cholesterol \\< 135 mg/dL)\n* Hypercholesterolemic volunteers (Total cholesterol 200-300 mg/dL; LDL-cholesterol 135-175 mg/dL)\n\nExclusion Criteria:\n\n* BMI \\> 30 Kg/m2\n* Smokers\n* Vegetarians\n* Pregnant women\n* Medication/consumption of vitamins, dietary supplements\n* On antibiotic treatment 3 months before starting the study\n* Digestive disorders/pathologies (gastric ulcer, Chron's disease, inflammatory bowel syndrome, etc.)\n* Food allergies/intolerances"}, 'identificationModule': {'nctId': 'NCT04998695', 'acronym': 'ORUJOSALUD-2', 'briefTitle': 'Health Effects of Consuming Olive Pomace Oil', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Instituto de Ciencia y Tecnología de Alimentos y Nutrición'}, 'officialTitle': 'Differential Study of the Health Effects of Olive Pomace Oil in Healthy and at Risk Consumers in Comparison With Sunflower Oil', 'orgStudyIdInfo': {'id': '20193239'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Olive pomace oil', 'description': 'Intake of 45 g/d of olive pomace oil as the only source of oil in the diet', 'interventionNames': ['Other: Olive pomace oil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sunflower oil', 'description': 'Intake of 45 g/d of sunflower oil as the only source of oil in the diet', 'interventionNames': ['Other: Sunflower oil']}], 'interventions': [{'name': 'Olive pomace oil', 'type': 'OTHER', 'otherNames': ['OPO'], 'description': 'Volunteers consumed during 4 weeks 45 g/d of olive pomace oil as the only source of dietary fat, used for cooking, salad dressing, toasts, etc.', 'armGroupLabels': ['Olive pomace oil']}, {'name': 'Sunflower oil', 'type': 'OTHER', 'otherNames': ['SO'], 'description': 'Volunteers consumed during 4 weeks 45 g/d of sunflower oil as the only source of dietary fat, used for cooking, salad dressing, toasts, etc.', 'armGroupLabels': ['Sunflower oil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Instituto de Ciencia y Tecnología de Alimentos y Nutrición', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Raquel Mateos, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ICTAN-CSIC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Ciencia y Tecnología de Alimentos y Nutrición', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Profesor', 'investigatorFullName': 'Laura Bravo', 'investigatorAffiliation': 'Instituto de Ciencia y Tecnología de Alimentos y Nutrición'}}}}