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Sponsors and Collaborators: |
Soroka University Medical Center LycoRed Ltd S.Daniel Abraham International Center for Health and Nutrition BGU |
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Information provided by: | Soroka University Medical Center |
ClinicalTrials.gov Identifier: | NCT00637858 |
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.
Condition | Intervention |
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Hypertension |
Dietary Supplement: Lyc-O-Mato 5mg Dietary Supplement: Lyc-O-Mato 15mg Dietary Supplement: Lyc-O-Mato 30mg Dietary Supplement: Lycopene capsules (non Lyc-o-mato) 15 mg Other: Placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Pharmacodynamics Study |
Official Title: | Effect of Different Doses of Tomato Lycopene on the Blood Pressure in Prehypertensives and Grade I Never Treated Otherwise Healthy Subjects |
Estimated Enrollment: | 130 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator |
Other: Placebo
Placebo capsules, identical looking to previous capsules for double-blind treatment period (8 weeks) and single blind run-in (4 weeks).
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2: Active Comparator
Lyc-o-Mato 5mg
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Dietary Supplement: Lyc-O-Mato 5mg
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
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3: Active Comparator
Lyc-o-Mato 15mg
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Dietary Supplement: Lyc-O-Mato 15mg
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
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4: Active Comparator
Lyc-o-Mato 30mg
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Dietary Supplement: Lyc-O-Mato 30mg
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
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5: Active Comparator
Lycopene capsules (non Lyc-o-mato) 15 mg
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Dietary Supplement: Lycopene capsules (non Lyc-o-mato) 15 mg
Daily Lycopene capsules (non Lyc-o-mato) 15 mg with lunch for 8 weeks (After 4 weeks of placebo run in).
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Ages Eligible for Study: | 35 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Israel | |
Hypertension clinic of the Soroka University Hospital | |
Beer Sheva, Israel |
Principal Investigator: | Ester Paran, Professor | Hypertension clinic of the Soroka University Hospital |
Responsible Party: | Hypertension clinic of the Soroka University Hospital ( Professor Ester Paran ) |
Study ID Numbers: | SOR459407CTIL |
Study First Received: | March 11, 2008 |
Last Updated: | March 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00637858 |
Health Authority: | Israel: Ministry of Health |
Lycopene Vascular Diseases Healthy Hypertension |
Anticarcinogenic Agents Radiation-Protective Agents Antioxidants Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Cardiovascular Diseases Protective Agents Pharmacologic Actions |