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

Not Applicable

Terminated

• Conditions: Hypertension
• Interventions: Other: Placebo; Dietary Supplement: Lyc-O-Mato 30mg; Dietary Supplement: Lycopene capsules (non Lyc-o-mato) 15 mg; Dietary Supplement: Lyc-O-Mato 5mg; Dietary Supplement: Lyc-O-Mato 15mg

• Registration Number: NCT00637858
• Lead Sponsor: Soroka University Medical Center

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%), 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-03-11
• Study First Submitted QC: 2008-03-17
• Study First Posted: 2008-03-18
• Study Start: 2008-10
• Status Verified: 2009-07
• Primary Completion: 2009-12
• Study Completion: 2011-01
• Last Update Submitted: 2013-01-06
• Last Update Posted: 2013-01-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	-
4	Lyc-O-Mato 30mg	Lyc-o-Mato 30mg
5	Lycopene capsules (non Lyc-o-mato) 15 mg	Lycopene capsules (non Lyc-o-mato) 15 mg
2	Lyc-O-Mato 5mg	Lyc-o-Mato 5mg
3	Lyc-O-Mato 15mg	Lyc-o-Mato 15mg

Primary Outcome Measures

Name	Time	Method
Blood Pressure	Every 2 weeks (Overall 12 weeks )

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hypertension Unit; 🇮🇱 Beer Sheva, Israel