Effect of Different Doses of Tomato Lycopene on Blood Pressure in Pre-hypertensive Otherwise Healthy Subjects
NCT ID: NCT00637858
Last Updated: 2013-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
130 participants
INTERVENTIONAL
2008-10-31
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
Placebo
Placebo capsules, identical looking to previous capsules for double-blind treatment period (8 weeks) and single blind run-in (4 weeks).
2
Lyc-o-Mato 5mg
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
3
Lyc-o-Mato 15mg
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
4
Lyc-o-Mato 30mg
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
5
Lycopene capsules (non Lyc-o-mato) 15 mg
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).
Interventions
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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
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
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
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).
Placebo
Placebo capsules, identical looking to previous capsules for double-blind treatment period (8 weeks) and single blind run-in (4 weeks).
Eligibility Criteria
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Inclusion Criteria
* No antihypertensive treatment in the past or present,
* 135\< SBP\< 145 or 85\<DBP\<95,
* Informed consent signed,
Exclusion Criteria
* Treated essential,
* secondary or complicated hypertension,
* SBP lower than 135 or higher than 145 mmHg,
* DBP lower than 85 or higher than 95 mmHg,
* Use of other medications (statins, NSAI ect..),
* Known allergy to tomato, carotenoids, or vitamin E,
* Diabetes Mellitus,
* Obesity BMI\>32,
* Significant dyslipidemia,
* Patients with ischemic pain, S/P MI, PTCA or CABG, LVH or CHF,
* Smoker,
* Valvular heart disease,
* PVD,
* Cerebrovascular disease, s/p CVA, TIA,
* Any kind of kidney disease (creatinine\>1.6),
* Chronic liver disease(elevated AST and ALT at least by 2 times of the normal range),
* Alcohol abuse,
* History of GI disease or surgery,
* History of malignancy in the past 5 years,
* History of autoimmune disease,
* Participation in other researches protocol
35 Years
60 Years
ALL
Yes
Sponsors
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LycoRed Ltd.
INDUSTRY
The S. Daniel Abraham International Center for Health and Nutrition
OTHER
Soroka University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Ester Paran, Professor
Role: PRINCIPAL_INVESTIGATOR
Hypertension clinic of the Soroka University Hospital
Locations
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Hypertension Unit
Beersheba, , Israel
Countries
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References
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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.
Other Identifiers
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SOR459407CTIL
Identifier Type: -
Identifier Source: org_study_id
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