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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014