Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT00637858
Status:
TERMINATED
Last Update Posted:
2013-01-08
First Post:
2008-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Different Doses of Tomato Lycopene on Blood Pressure in Pre-hypertensive Otherwise Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077276', 'term': 'Lycopene'}], 'ancestors': [{'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'whyStopped': 'difficulty to enroll more subjects', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-06', 'studyFirstSubmitDate': '2008-03-11', 'studyFirstSubmitQcDate': '2008-03-17', 'lastUpdatePostDateStruct': {'date': '2013-01-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Pressure', 'timeFrame': 'Every 2 weeks (Overall 12 weeks )'}], 'secondaryOutcomes': [{'measure': 'Serum lycopene levels', 'timeFrame': 'Week 0,Week 12'}, {'measure': 'Serum Phytofluene levels', 'timeFrame': 'Week 0,Week 12'}, {'measure': 'Serum 8 isoprostane levels', 'timeFrame': 'Week 0,Week 12'}, {'measure': 'Serum nitrite-nitrate levels', 'timeFrame': 'Week 0,Week 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '16368299', 'type': 'BACKGROUND', 'citation': 'Engelhard YN, Gazer B, Paran E. Natural antioxidants from tomato extract reduce blood pressure in patients with grade-1 hypertension: a double-blind, placebo-controlled pilot study. Am Heart J. 2006 Jan;151(1):100. doi: 10.1016/j.ahj.2005.05.008.'}]}, 'descriptionModule': {'briefSummary': 'Effect of different doses of tomato extract (contain Lyc-o-Mato 6% Oleoresin which Contain: 5, 15 mg lycopene , in addition to Beta-carotene (0.15%), phytoene, and phytofluene (1%); and vitamin E (2%), phospholipids (15%), and phytosterols (0.6%) suspended in tomato oleoresin oil) compared with synthetic lycopene on blood pressure and plasma lycopene levels in never treated pre-hypertensive otherwise healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 35-60,\n* No antihypertensive treatment in the past or present,\n* 135\\< SBP\\< 145 or 85\\<DBP\\<95,\n* Informed consent signed,\n\nExclusion Criteria:\n\n* Unwilling to participate in the study,\n* Treated essential,\n* secondary or complicated hypertension,\n* SBP lower than 135 or higher than 145 mmHg,\n* DBP lower than 85 or higher than 95 mmHg,\n* Use of other medications (statins, NSAI ect..),\n* Known allergy to tomato, carotenoids, or vitamin E,\n* Diabetes Mellitus,\n* Obesity BMI\\>32,\n* Significant dyslipidemia,\n* Patients with ischemic pain, S/P MI, PTCA or CABG, LVH or CHF,\n* Smoker,\n* Valvular heart disease,\n* PVD,\n* Cerebrovascular disease, s/p CVA, TIA,\n* Any kind of kidney disease (creatinine\\>1.6),\n* Chronic liver disease(elevated AST and ALT at least by 2 times of the normal range),\n* Alcohol abuse,\n* History of GI disease or surgery,\n* History of malignancy in the past 5 years,\n* History of autoimmune disease,\n* Participation in other researches protocol'}, 'identificationModule': {'nctId': 'NCT00637858', 'briefTitle': 'Effect of Different Doses of Tomato Lycopene on Blood Pressure in Pre-hypertensive Otherwise Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Soroka University Medical Center'}, 'officialTitle': 'Effect of Different Doses of Tomato Lycopene on the Blood Pressure in Prehypertensives and Grade I Never Treated Otherwise Healthy Subjects', 'orgStudyIdInfo': {'id': 'SOR459407CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'interventionNames': ['Other: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Lyc-o-Mato 5mg', 'interventionNames': ['Dietary Supplement: Lyc-O-Mato 5mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Lyc-o-Mato 15mg', 'interventionNames': ['Dietary Supplement: Lyc-O-Mato 15mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'description': 'Lyc-o-Mato 30mg', 'interventionNames': ['Dietary Supplement: Lyc-O-Mato 30mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': '5', 'description': 'Lycopene capsules (non Lyc-o-mato) 15 mg', 'interventionNames': ['Dietary Supplement: Lycopene capsules (non Lyc-o-mato) 15 mg']}], 'interventions': [{'name': 'Lyc-O-Mato 5mg', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Daily Lyc-O-Mato 5mg with lunch for 8 weeks (After 4 weeks of placebo run in). Lyc-O-Mato 6%, Natural tomato Complex, is packed into soft gelatin capsule', 'armGroupLabels': ['2']}, {'name': 'Lyc-O-Mato 15mg', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Daily Lyc-O-Mato 15mg with lunch for 8 weeks (After 4 weeks of placebo run in). Lyc-O-Mato 6%, Natural tomato Complex, is packed into soft gelatin capsule', 'armGroupLabels': ['3']}, {'name': 'Lyc-O-Mato 30mg', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Daily Lyc-O-Mato 30mg with lunch for 8 weeks (After 4 weeks of placebo run in). Lyc-O-Mato 6%, Natural tomato Complex, is packed into soft gelatin capsule', 'armGroupLabels': ['4']}, {'name': 'Lycopene capsules (non Lyc-o-mato) 15 mg', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Daily Lycopene capsules (non Lyc-o-mato) 15 mg with lunch for 8 weeks (After 4 weeks of placebo run in).', 'armGroupLabels': ['5']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo capsules, identical looking to previous capsules for double-blind treatment period (8 weeks) and single blind run-in (4 weeks).', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84101', 'city': 'Beersheba', 'country': 'Israel', 'facility': 'Hypertension Unit', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}], 'overallOfficials': [{'name': 'Ester Paran, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hypertension clinic of the Soroka University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soroka University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'LycoRed Ltd.', 'class': 'INDUSTRY'}, {'name': 'The S. Daniel Abraham International Center for Health and Nutrition', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}