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

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.

Conditions

• Hypertension

Interventions

DIETARY_SUPPLEMENT

Lyc-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_SUPPLEMENT

Lyc-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_SUPPLEMENT

Lyc-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_SUPPLEMENT

Lycopene 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).

OTHER

Placebo

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

Sponsors & Collaborators

• LycoRed Ltd.

  collaborator INDUSTRY

• The S. Daniel Abraham International Center for Health and Nutrition

  collaborator OTHER

• Soroka University Medical Center

  lead OTHER

Principal Investigators

• Ester Paran, Professor · Hypertension clinic of the Soroka University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-10-31

Primary Completion

2009-12-31

Completion

2011-01-31

Countries

• Israel

Study Locations