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

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ClinicalTrials.gov Identifier: NCT00637858
Recruitment Status : Terminated (difficulty to enroll more subjects)
First Posted : March 18, 2008
Last Update Posted : January 8, 2013
Sponsor:
Collaborators:
LycoRed Ltd.
The S. Daniel Abraham International Center for Health and Nutrition
Information provided by (Responsible Party):
Soroka University Medical Center

Tracking Information
First Submitted Date  ICMJE March 11, 2008
First Posted Date  ICMJE March 18, 2008
Last Update Posted Date January 8, 2013
Study Start Date  ICMJE October 2008
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2008)
Blood Pressure [ Time Frame: Every 2 weeks (Overall 12 weeks ) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00637858 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2008)
  • Serum lycopene levels [ Time Frame: Week 0,Week 12 ]
  • Serum Phytofluene levels [ Time Frame: Week 0,Week 12 ]
  • Serum 8 isoprostane levels [ Time Frame: Week 0,Week 12 ]
  • Serum nitrite-nitrate levels [ Time Frame: Week 0,Week 12 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Different Doses of Tomato Lycopene on Blood Pressure in Pre-hypertensive Otherwise Healthy Subjects
Official Title  ICMJE Effect of Different Doses of Tomato Lycopene on the Blood Pressure in Prehypertensives and Grade I Never Treated Otherwise Healthy Subjects
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • 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).
Study Arms  ICMJE
  • Placebo Comparator: 1
    Intervention: Other: Placebo
  • Active Comparator: 2
    Lyc-o-Mato 5mg
    Intervention: Dietary Supplement: Lyc-O-Mato 5mg
  • Active Comparator: 3
    Lyc-o-Mato 15mg
    Intervention: Dietary Supplement: Lyc-O-Mato 15mg
  • Active Comparator: 4
    Lyc-o-Mato 30mg
    Intervention: Dietary Supplement: Lyc-O-Mato 30mg
  • Active Comparator: 5
    Lycopene capsules (non Lyc-o-mato) 15 mg
    Intervention: Dietary Supplement: Lycopene capsules (non Lyc-o-mato) 15 mg
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 17, 2008)
130
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00637858
Other Study ID Numbers  ICMJE SOR459407CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Soroka University Medical Center
Study Sponsor  ICMJE Soroka University Medical Center
Collaborators  ICMJE
  • LycoRed Ltd.
  • The S. Daniel Abraham International Center for Health and Nutrition
Investigators  ICMJE
Principal Investigator: Ester Paran, Professor Hypertension clinic of the Soroka University Hospital
PRS Account Soroka University Medical Center
Verification Date July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP