NCT00637858

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Oct 2008

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 18, 2008

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

January 8, 2013

Status Verified

July 1, 2009

Enrollment Period

1.2 years

First QC Date

March 11, 2008

Last Update Submit

January 6, 2013

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Blood Pressure

    Every 2 weeks (Overall 12 weeks )

Secondary Outcomes (4)

  • Serum lycopene levels

    Week 0,Week 12

  • Serum Phytofluene levels

    Week 0,Week 12

  • Serum 8 isoprostane levels

    Week 0,Week 12

  • Serum nitrite-nitrate levels

    Week 0,Week 12

Study Arms (5)

1

PLACEBO COMPARATOR
Other: Placebo

2

ACTIVE COMPARATOR

Lyc-o-Mato 5mg

Dietary Supplement: Lyc-O-Mato 5mg

3

ACTIVE COMPARATOR

Lyc-o-Mato 15mg

Dietary Supplement: Lyc-O-Mato 15mg

4

ACTIVE COMPARATOR

Lyc-o-Mato 30mg

Dietary Supplement: Lyc-O-Mato 30mg

5

ACTIVE COMPARATOR

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

Dietary Supplement: Lycopene capsules (non Lyc-o-mato) 15 mg

Interventions

Lyc-O-Mato 5mgDIETARY_SUPPLEMENT

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

2
Lyc-O-Mato 15mgDIETARY_SUPPLEMENT

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

3
Lyc-O-Mato 30mgDIETARY_SUPPLEMENT

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

4
Lycopene capsules (non Lyc-o-mato) 15 mgDIETARY_SUPPLEMENT

Daily Lycopene capsules (non Lyc-o-mato) 15 mg with lunch for 8 weeks (After 4 weeks of placebo run in).

5
PlaceboOTHER

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

1

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 35-60,
  • No antihypertensive treatment in the past or present,
  • \< SBP\< 145 or 85\<DBP\<95,
  • Informed consent signed,

You may not qualify if:

  • 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,
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hypertension Unit

Beersheba, 84101, Israel

Location

Related 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. doi: 10.1016/j.ahj.2005.05.008.

    PMID: 16368299BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

Lycopene

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

CarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological Factors

Study Officials

  • Ester Paran, Professor

    Hypertension clinic of the Soroka University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2008

First Posted

March 18, 2008

Study Start

October 1, 2008

Primary Completion

December 1, 2009

Study Completion

January 1, 2011

Last Updated

January 8, 2013

Record last verified: 2009-07

Locations

IL(1)