Effect of Different Doses of Tomato Lycopene on Blood Pressure in Pre-hypertensive Otherwise Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Different Doses of Tomato Lycopene on the Blood Pressure in Prehypertensives and Grade I Never Treated Otherwise Healthy Subjects

Conditions
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Hypertension

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 35-60, No antihypertensive treatment in the past or present, 135< SBP< 145 or 85<DBP<95, Informed consent signed, Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Other: Placebo<br>* Placebo capsules, identical looking to previous capsules for double-blind treatment period (8 weeks) and single blind run-in (4 weeks).<br>|
| Active Comparator: 2<br>Lyc-o-Mato 5mg | Dietary Supplement: Lyc-O-Mato 5mg<br>* 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<br>|
| Active Comparator: 3<br>Lyc-o-Mato 15mg | Dietary Supplement: Lyc-O-Mato 15mg<br>* 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<br>|
| Active Comparator: 4<br>Lyc-o-Mato 30mg | Dietary Supplement: Lyc-O-Mato 30mg<br>* 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<br>|
| Active Comparator: 5<br>Lycopene capsules (non Lyc-o-mato) 15 mg | Dietary Supplement: Lycopene capsules (non Lyc-o-mato) 15 mg<br>* Daily Lycopene capsules (non Lyc-o-mato) 15 mg with lunch for 8 weeks (After 4 weeks of placebo run in).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure |  | Every 2 weeks (Overall 12 weeks ) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum lycopene levels |  | Week 0,Week 12 | 
| Serum Phytofluene levels |  | Week 0,Week 12 | 
| Serum 8 isoprostane levels |  | Week 0,Week 12 | 
| Serum nitrite-nitrate levels |  | Week 0,Week 12 |