NCT00637858

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Soroka University Medical Center · Academic / Other
• Sex: All
• Age: 35 Years – 60 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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).

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-12-01
• Completion: 2011-01-01
• First posted: 2008-03-18
• Last updated: 2013-01-08

Locations

1 site across 1 country: Israel