Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2025-12-25 @ 12:42 PM
Study NCT ID:
NCT04874961
Status:
COMPLETED
Last Update Posted:
2024-11-15
First Post:
2021-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Olive Polyphenols in Cardiovascular Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092244', 'term': 'Isolated Systolic Hypertension'}], 'ancestors': [{'id': 'D000075222', 'term': 'Essential Hypertension'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-14', 'studyFirstSubmitDate': '2021-04-27', 'studyFirstSubmitQcDate': '2021-04-30', 'lastUpdatePostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from baseline insuline level at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Required to correctly interpret glucose levels, Measurement in Serum'}, {'measure': 'Change from baseline homocysteine level at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Measurement in Homocysteine Serum'}, {'measure': 'Change from baseline hs-CRP level at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Measurement in Serum'}, {'measure': 'Change from baseline creatinine level at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Required to correctly interpret HbAc1 levels, Measurement in Serum'}, {'measure': 'Change from baseline HbA1c level at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Measurement in EDTA Whole Blood'}, {'measure': 'Change from baseline hemoglobine level at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Required to correctly interpret HbAc1 levels, Measurement in EDTA Whole Blood'}, {'measure': 'Change from baseline creatine kinase (CK) level at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Measurement in serum'}, {'measure': 'Change from baseline C-peptide level at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Measurement in serum'}, {'measure': 'Change from baseline waist circumference at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Measurement with measuring tape'}, {'measure': 'Change from baseline Body Mass Index (BMI) at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'weight and height will be combined to report BMI in kg/m\\^2'}, {'measure': 'Change from baseline glucose level at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Measurement in Fluoride Plasma'}], 'primaryOutcomes': [{'measure': 'Change from baseline Blood Pressure, Systolic at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'average of 3 measurements during 15 minutes'}], 'secondaryOutcomes': [{'measure': 'Frequency of side effects (+ their burden) as reported in the final questionnaire', 'timeFrame': '8 weeks', 'description': 'Unvalidated but standardized questionnaire on typical statin-related side effects'}, {'measure': 'Change from baseline Blood Pressure, diastolic at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'average of 3 measurements during 15 minutes'}, {'measure': 'Change from baseline Blood Pressure, systolic at 4 weeks', 'timeFrame': 'Baseline, 4 weeks', 'description': 'average of 3 measurements during 15 minutes'}, {'measure': 'Change from baseline LDL cholesterol level at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Calculated from Total Cholesterol, HDL Cholesterol and Triglycerides'}, {'measure': 'Change from baseline HDL cholesterol level at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Measurement in Serum'}, {'measure': 'Change from baseline non-HDL cholesterol level at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Calculated from HDL and total cholesterol'}, {'measure': 'Change from baseline total cholesterol level at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Measurement in Serum'}, {'measure': 'Change from baseline triglycerides level at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Measurement in Serum'}, {'measure': 'Change from baseline Apo A1 level at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Measurement in Serum'}, {'measure': 'Change from baseline Apo B level at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Measurement in Serum'}, {'measure': 'Change from baseline lipoprotein A (LP(a)) level at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Measurement in Serum'}, {'measure': 'Change from baseline OxLDL level at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Measurement with ELISA'}, {'measure': 'Change from baseline gluathion (GSH) level at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Measurement with in house HPLC method'}, {'measure': 'Change from baseline malondialdehyde (MDA) level at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Measurement with ELISA'}, {'measure': 'Change from baseline Remnant Cholesterol at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Calculated from total, HDL and LDL cholesterol'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension, Systolic']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate whether the use of a commercially available standardized olive extract (Tensiofytol®) in individuals with elevated blood pressure\n\n1. Leads to a clinically relevant reduction of blood pressure on the short term,\n2. Leads to a clinically relevant reduction of cholesterol levels, especially LDL,\n3. Leads to a change in oxidative stress biomarkers.\n\nParticipants will be stratified by sex before randomization to one of the three treatments for 8 weeks:\n\n* Tensiofytol: 100 mg oleuropein and 20 mg hydroxytyrosol per day\n* Placebo\n\nAll treatments have an identical shape and color and should be used in the same way (oral intake; 3 capsules/day during dinner). No dietary instructions are given and participants are asked not to change their dietary habits, nor to start other therapies (medication, supplements, slimming diets, extra physical activity, etc.) during their study period. Standardized questionnaires are used to obtain information on demographics, dietary habits and side effects. At baseline and after 8 weeks, 27 ml blood is drawn for various biological analyses, and blood pressure, BMI and waist circumference are measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '76 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Systolic blood pressure ≥ 130 mmHg\n\nExclusion Criteria:\n\n* \\<18 jaar\n* \\>76 jaar\n* Smoking\n* Use of nutritional supplements or (chronic) medication\\*\n* Triglycerides \\> 400 mg/dL\n* \\> 14 alcoholic consumptions/week\n* Chronic illness (e.g. diabetes, atherosclerosis, reumatoid arthritis)\n* Acute infection\n* Current pregnancy or pregnancy wish during the study period\n* Breast feeding\n\n * When nutritional supplements were used regularly, participation is allowed after a 10-day wash out period.\n\nUse of medication will be individually assessed and is permitted if it does not interfere with the used treatments and the patient is stable on the medication.'}, 'identificationModule': {'nctId': 'NCT04874961', 'briefTitle': 'Olive Polyphenols in Cardiovascular Prevention', 'organization': {'class': 'OTHER', 'fullName': 'Universiteit Antwerpen'}, 'officialTitle': 'Olive Polyphenols in Cardiovascular Prevention: Efficacy and Tolerability of a Commercially Available Standardized Olive Extract (Tensiofytol®) as Compared to Placebo in Patients With Elevated Blood Pressure: a RDBPC Trial.', 'orgStudyIdInfo': {'id': 'Olijfstudie 2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standardized olive extract (Tensiofytol®)', 'description': '3 capsules/day during dinner Per day: 334 mg olive leave dry extract and 106 mg olive fruit dry extract (Olea europaea L.), equivalent to 100 mg oleuropein and 20 mg hydroxytyrosol', 'interventionNames': ['Dietary Supplement: Tensiofytol®']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '3 capsules/day during dinner', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Tensiofytol®', 'type': 'DIETARY_SUPPLEMENT', 'description': 'standardized olive extract', 'armGroupLabels': ['Standardized olive extract (Tensiofytol®)']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'contains excipients only', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wilrijk', 'country': 'Belgium', 'facility': 'UAntwerp, NatuRAPT', 'geoPoint': {'lat': 51.16734, 'lon': 4.39513}}], 'overallOfficials': [{'name': 'Johan Bosmans, Prof. MD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Antwerp'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nina Hermans', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Antwerp', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Nina Hermans', 'investigatorAffiliation': 'Universiteit Antwerpen'}}}}