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

Primary Purpose

Hypertension

Status

Terminated

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Lyc-O-Mato 5mg

Lyc-O-Mato 15mg

Lyc-O-Mato 30mg

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

Placebo

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

35 Years - 60 Years (Adult)All SexesAccepts 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

Sites / Locations

Hypertension Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Arm Description

Lyc-o-Mato 5mg

Lyc-o-Mato 15mg

Lyc-o-Mato 30mg

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

Outcomes

Primary Outcome Measures

Blood Pressure

Secondary Outcome Measures

Serum lycopene levels

Serum Phytofluene levels

Serum 8 isoprostane levels

Serum nitrite-nitrate levels

Full Information

NCT ID

NCT00637858

First Posted

March 11, 2008

Last Updated

January 6, 2013

Sponsor

Soroka University Medical Center

Collaborators

LycoRed Ltd., The S. Daniel Abraham International Center for Health and Nutrition

1. Study Identification

Unique Protocol Identification Number

NCT00637858

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Terminated

Why Stopped

difficulty to enroll more subjects

Study Start Date

October 2008 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Soroka University Medical Center

Collaborators

LycoRed Ltd., The S. Daniel Abraham International Center for Health and Nutrition

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

130 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Title

Arm Type

Active Comparator

Arm Description

Lyc-o-Mato 5mg

Arm Title

Arm Type

Active Comparator

Arm Description

Lyc-o-Mato 15mg

Arm Title

Arm Type

Active Comparator

Arm Description

Lyc-o-Mato 30mg

Arm Title

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Lyc-O-Mato 5mg

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Lyc-O-Mato 15mg

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Lyc-O-Mato 30mg

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

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

Intervention Description

Daily Lycopene capsules (non Lyc-o-mato) 15 mg with lunch for 8 weeks (After 4 weeks of placebo run in).

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Blood Pressure

Time Frame

Every 2 weeks (Overall 12 weeks )

Secondary Outcome Measure Information:

Title

Serum lycopene levels

Time Frame

Week 0,Week 12

Title

Serum Phytofluene levels

Time Frame

Week 0,Week 12

Title

Serum 8 isoprostane levels

Time Frame

Week 0,Week 12

Title

Serum nitrite-nitrate levels

Time Frame

Week 0,Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ester Paran, Professor

Organizational Affiliation

Hypertension clinic of the Soroka University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hypertension Unit

City

Beer Sheva

ZIP/Postal Code

84101

Country

Israel

12. IPD Sharing Statement

Citations:

PubMed Identifier

16368299

Citation

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.

Results Reference

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

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