Status:
TERMINATED
Effect of Different Doses of Tomato Lycopene on Blood Pressure in Pre-hypertensive Otherwise Healthy Subjects
Lead Sponsor:
Soroka University Medical Center
Collaborating Sponsors:
LycoRed Ltd.
The S. Daniel Abraham International Center for Health and Nutrition
Conditions:
Hypertension
Eligibility:
All Genders
35-60 years
Phase:
NA
Brief Summary
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%)...
Eligibility Criteria
Inclusion
- Aged 35-60,
- No antihypertensive treatment in the past or present,
- 135\< SBP\< 145 or 85\<DBP\<95,
- Informed consent signed,
Exclusion
- Unwilling to participate in the study,
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00637858
Start Date
October 1 2008
End Date
January 1 2011
Last Update
January 8 2013
Active Locations (1)
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1
Hypertension Unit
Beersheba, Israel, 84101