Effect of Different Doses of Tomato Lycopene on Blood Pressure in Pre-Hypertensive Otherwise Healthy Subjects - Full Text View

Sponsors and Collaborators:	Soroka University Medical Center LycoRed Ltd S.Daniel Abraham International Center for Health and Nutrition BGU
Information provided by:	Soroka University Medical Center
ClinicalTrials.gov Identifier:	NCT00637858

Purpose

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.

Condition	Intervention
Hypertension	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 Other: Placebo

MedlinePlus related topics: Dietary Supplements High Blood Pressure

Drug Information available for: Gelatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Pharmacodynamics Study
Official Title:	Effect of Different Doses of Tomato Lycopene on the Blood Pressure in Prehypertensives and Grade I Never Treated Otherwise Healthy Subjects

Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:

Blood Pressure [ Time Frame: Every 2 weeks (Overall 12 weeks ) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Serum lycopene levels [ Time Frame: Week 0,Week 12 ] [ Designated as safety issue: No ]
Serum Phytofluene levels [ Time Frame: Week 0,Week 12 ] [ Designated as safety issue: No ]
Serum 8 isoprostane levels [ Time Frame: Week 0,Week 12 ] [ Designated as safety issue: No ]
Serum nitrite-nitrate levels [ Time Frame: Week 0,Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	130
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Other: Placebo Placebo capsules, identical looking to previous capsules for double-blind treatment period (8 weeks) and single blind run-in (4 weeks).
2: Active Comparator 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
3: Active Comparator 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
4: Active Comparator 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
5: Active Comparator 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).

Eligibility

Ages Eligible for Study:	35 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637858

Locations

Israel
Hypertension clinic of the Soroka University Hospital
Beer Sheva, Israel

Sponsors and Collaborators

Soroka University Medical Center

LycoRed Ltd

S.Daniel Abraham International Center for Health and Nutrition BGU

Investigators

Principal Investigator:

Ester Paran, Professor

Hypertension clinic of the Soroka University Hospital

More Information

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.

Responsible Party:	Hypertension clinic of the Soroka University Hospital ( Professor Ester Paran )
Study ID Numbers:	SOR459407CTIL
Study First Received:	March 11, 2008
Last Updated:	March 17, 2008
ClinicalTrials.gov Identifier:	NCT00637858
Health Authority:	Israel: Ministry of Health

Study placed in the following topic categories:

Lycopene
Vascular Diseases
Healthy
Hypertension

Additional relevant MeSH terms:

Anticarcinogenic Agents
Radiation-Protective Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Cardiovascular Diseases
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009