Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-03-03 @ 4:27 AM
Study NCT ID:
NCT06490133
Status:
COMPLETED
Last Update Posted:
2024-12-09
First Post:
2024-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Consuming Olive Extract on Total Cholesterol Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel groups double blind, 12-week nutritional intervention'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-04', 'studyFirstSubmitDate': '2024-06-28', 'studyFirstSubmitQcDate': '2024-07-05', 'lastUpdatePostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total cholesterol', 'timeFrame': 'Baseline', 'description': 'Serum concentration of Total Cholesterol'}, {'measure': 'Total cholesterol', 'timeFrame': '12 weeks', 'description': 'Serum concentration of Total Cholesterol'}, {'measure': 'HDL cholesterol', 'timeFrame': 'Baseline', 'description': 'Serum concentration of HDL cholesterol'}, {'measure': 'HDL cholesterol', 'timeFrame': '12 weeks', 'description': 'Serum concentration of HDL cholesterol'}, {'measure': 'LDL cholesterol', 'timeFrame': 'Baseline', 'description': 'Serum Calculated LDL Cholesterol levels'}, {'measure': 'LDL cholesterol', 'timeFrame': '12 weeks', 'description': 'Serum Calculated LDL Cholesterol levels'}, {'measure': 'Triglycerides', 'timeFrame': 'Baseline', 'description': 'Serum Triglycerides levels'}, {'measure': 'Triglycerides', 'timeFrame': '12 weeks', 'description': 'Serum Triglycerides levels'}], 'secondaryOutcomes': [{'measure': 'Weight', 'timeFrame': 'Baseline', 'description': 'Weight status'}, {'measure': 'Weight', 'timeFrame': '12 weeks', 'description': 'Weight status'}, {'measure': 'Fat mass', 'timeFrame': 'Baseline', 'description': 'Fat mass in kg, measured by Bioimpedance'}, {'measure': 'Fat mass', 'timeFrame': '12 weeks', 'description': 'Fat mass in kg, measured by Bioimpedance'}, {'measure': 'Hemoglobin', 'timeFrame': 'Baseline', 'description': 'Hemoglobin measured as mg/dL'}, {'measure': 'Hemoglobin', 'timeFrame': '12 weeks', 'description': 'Hemoglobin measured as mg/dL'}, {'measure': 'Hematocrit', 'timeFrame': 'Baseline', 'description': 'Hematocrit (%)'}, {'measure': 'Hematocrit', 'timeFrame': '12 weeks', 'description': 'Hematocrit (%)'}, {'measure': 'Physical Activity', 'timeFrame': 'Baseline', 'description': 'Measured through the IPAQ questionnaire'}, {'measure': 'Physical Activity', 'timeFrame': '12 weeks', 'description': 'Measured through the IPAQ questionnaire'}, {'measure': 'Blood pressure', 'timeFrame': 'Baseline', 'description': 'Measured in the dominant arm (mmHg)'}, {'measure': 'Blood pressure', 'timeFrame': '12 weeks', 'description': 'Measured in the dominant arm (mmHg)'}, {'measure': 'Dietary intake', 'timeFrame': 'Baseline', 'description': 'FFQ from the SUN Study'}, {'measure': 'Dietary intake', 'timeFrame': '12 weeks', 'description': 'FFQ from the SUN Study'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['polyhpenols from olives', 'metabolic syndrome', 'cholesterol', 'lifestyle'], 'conditions': ['Metabolic Syndrome | Serum or Plasma | Chemistry - Non-Challenge', 'Overweight']}, 'descriptionModule': {'briefSummary': 'The main objective of this nutritional intervention is to assess the efficacy of polyphenol-rich capsules on reducing metabolic syndrome traits, mainly cholesterol levels. For this purpose, a double blind, placebo controlled study of 12 weeks will be carried out.\n\nThe target population is women and men with overweight or obesity. Researchers will compare the experimental capsules with placebo capsules, but will be blinded during the intervention and results analyses. Only after analysing the parameters, the groups will be revealed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI between 25 and 35 Kg/m2\n* Total Cholesterol levels in peripheral blood above or equal to 200 mg/dL or LDL-cholesterol levels above or equal to 160 mg/dL.\n* Weight stability during the three months prior the start of the study (±5% of variation).\n* To be able to attend the visits and accomplish with all the indications of the research staff.\n* To have signed the written informed consent.\n\nExclusion Criteria:\n\n* Any alteration of the Gastrointestinal system, functional or structural (gastric ulcer, chronic inflammatory diseases, hernia, etc.)\n* Subjects having undergone any surgical operation in th egastrointestinal tract with permanent consequences (i.e. gastroduodenectomy).\n* Subjects following any pharmacological treatment affecting gastric homeostasis.\n* Suffer from any metabolic disease or cancer process.\n* Being allergic to any of the compounds contained in the study capsules.\n* Excessive alcohol ingestion (14 units/day for women, or 20 units/day for men).\n* Women lactating or during pregnancy.\n* Following any cholesterol-lowering treatment.\n* People with any mental impairment or whose compliance with the study protocol is at risk.'}, 'identificationModule': {'nctId': 'NCT06490133', 'acronym': 'OLICOL', 'briefTitle': 'Evaluation of Consuming Olive Extract on Total Cholesterol Levels', 'organization': {'class': 'OTHER', 'fullName': 'Clinica Universidad de Navarra, Universidad de Navarra'}, 'officialTitle': 'Nutritional Intervention to Evaluate the Effectiveness of the Consumption of Dehydrated Olive Pulp in Reducing Total Cholesterol Levels in Subjects with Overweight-obesity and High Total Cholesterol Levels', 'orgStudyIdInfo': {'id': 'OLICOL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Capsules containing placebo.', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Polyhpenol extract', 'description': 'Capsules containing the experimental polyhpenol to be assayed', 'interventionNames': ['Dietary Supplement: Polyhpenol extract']}], 'interventions': [{'name': 'Polyhpenol extract', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Three capsules in fasting conditions 15 minutes prior breakfast', 'armGroupLabels': ['Polyhpenol extract']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Three capsules in fasting conditions 15 minutes before breakfast', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'country': 'Spain', 'facility': 'Centro de Investigacion en Nutricion. Universidad de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinica Universidad de Navarra, Universidad de Navarra', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}