Trial | NCT00637858  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    prolycopene ...

  • Study Participants

    130
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 Started
Oct 31
2008
Primary Completion
Dec 31
2009
Study Completion
Jan 31
2011
Last Update
Jan 08
2013
Estimate

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

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

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

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).

Other Placebo

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

1 Placebo Comparator

2 Active Comparator

Lyc-o-Mato 5mg

3 Active Comparator

Lyc-o-Mato 15mg

4 Active Comparator

Lyc-o-Mato 30mg

5 Active Comparator

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

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
No Results Posted