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

Soroka University Medical Center

Status: Terminated

Conditions: Hypertension

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00637858

SOR459407CTIL

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 35 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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130 participants in 5 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Other: Placebo

2

Active Comparator group

Description:

Lyc-o-Mato 5mg

Treatment:

Dietary Supplement: Lyc-O-Mato 5mg

3

Active Comparator group

Description:

Lyc-o-Mato 15mg

Treatment:

Dietary Supplement: Lyc-O-Mato 15mg

4

Active Comparator group

Description:

Lyc-o-Mato 30mg

Treatment:

Dietary Supplement: Lyc-O-Mato 30mg

5

Active Comparator group

Description:

Lycopene capsules (non Lyc-o-mato) 15 mg

Treatment:

Dietary Supplement: Lycopene capsules (non Lyc-o-mato) 15 mg