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

This study has been terminated.
(difficulty to enroll more subjects)
Sponsor:
Collaborators:
LycoRed Ltd.
S.Daniel Abraham International Center for Health and Nutrition BGU
Information provided by (Responsible Party):
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00637858
First received: March 11, 2008
Last updated: January 6, 2013
Last verified: July 2009
History of Changes
  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

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

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 130
Study Start Date: October 2008
Study Completion Date: January 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  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 Unit
Beer Sheva, Israel, 84101
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:

Responsible Party: Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT00637858     History of Changes
Other Study ID Numbers: SOR459407CTIL
Study First Received: March 11, 2008
Last Updated: January 6, 2013
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lycopene
Carotenoids
Antioxidants
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013