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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00637858
• Other study ID #: SOR459407CTIL
• Status: Terminated
• Phase: N/A
• First received: March 11, 2008
• Last updated: January 6, 2013
• Start date: October 2008
• Est. completion date: January 2011

Study information

• Verified date: July 2009
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 130
• Est. completion date: January 2011
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

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
• 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
• 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
• 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).

Locations

Country	Name	City	State
Israel	Hypertension Unit	Beer Sheva

Sponsors (3)

Lead Sponsor	Collaborator
Soroka University Medical Center	LycoRed Ltd., S.Daniel Abraham International Center for Health and Nutrition BGU

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure		Every 2 weeks (Overall 12 weeks )	No
Secondary	Serum lycopene levels		Week 0,Week 12	No
Secondary	Serum Phytofluene levels		Week 0,Week 12	No
Secondary	Serum 8 isoprostane levels		Week 0,Week 12	No
Secondary	Serum nitrite-nitrate levels		Week 0,Week 12	No