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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00637858

Enrollment

130

Registered

2008-03-18

Start date

2008-10-31

Completion date

2011-01-31

Last updated

2013-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

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.

Interventions

DIETARY_SUPPLEMENTLyc-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

DIETARY_SUPPLEMENTLyc-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

DIETARY_SUPPLEMENTLyc-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

DIETARY_SUPPLEMENTLycopene 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).

OTHERPlacebo

Placebo capsules, identical looking to previous capsules for double-blind treatment period (8 weeks) and single blind run-in (4 weeks).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

35 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Blood Pressure	Every 2 weeks (Overall 12 weeks )

Secondary

Measure	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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026