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

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.

Study Overview

• Status: Terminated
• Conditions: Hypertension
• Intervention / Treatment: Other: Placebo; Dietary supplement: Lyc-O-Mato 5mg; Dietary supplement: Lyc-O-Mato 15mg; Dietary supplement: Lyc-O-Mato 30mg; Dietary supplement: Lycopene capsules (non Lyc-o-mato) 15 mg

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Beer Sheva, Israel, 84101
    • Hypertension Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 33 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 1	Other: Placebo; Placebo capsules, identical looking to previous capsules for double-blind treatment period (8 weeks) and single blind run-in (4 weeks).
Active Comparator: 2; Lyc-o-Mato 5mg	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
Active Comparator: 3; Lyc-o-Mato 15mg	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
Active Comparator: 4; Lyc-o-Mato 30mg	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
Active Comparator: 5; Lycopene capsules (non Lyc-o-mato) 15 mg	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood Pressure	Every 2 weeks (Overall 12 weeks )

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Soroka University Medical Center
• Collaborators: The S. Daniel Abraham International Center for Health and Nutrition; LycoRed Ltd.
• Investigators: Principal Investigator: Ester Paran, Professor, Hypertension clinic of the Soroka University Hospital

Publications and helpful links

General Publications

• Engelhard YN, Gazer B, Paran E. Natural antioxidants from tomato extract reduce blood pressure in patients with grade-1 hypertension: a double-blind, placebo-controlled pilot study. Am Heart J. 2006 Jan;151(1):100. doi: 10.1016/j.ahj.2005.05.008.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: March 11, 2008
• First Submitted That Met QC Criteria: March 17, 2008
• First Posted (Estimate): March 18, 2008

Study Record Updates

• Last Update Posted (Estimate): January 8, 2013
• Last Update Submitted That Met QC Criteria: January 6, 2013
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Antineoplastic Agents; Protective Agents; Antioxidants; Anticarcinogenic Agents; Radiation-Protective Agents; Lycopene
• Other Study ID Numbers: SOR459407CTIL