HypertensionNCT00637858
Effect of Different Doses of Tomato Lycopene on Blood Pressure in Pre-hypertensive Otherwise Healthy Subjects
A study testing Lyc-O-Mato 5mg, Lyc-O-Mato 15mg and Lyc-O-Mato 30mg in people with Hypertension, run by Soroka University Medical Center at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Lyc-O-Mato 5mg, Lyc-O-Mato 15mg and Lyc-O-Mato 30mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2008to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 35-60,
- No antihypertensive treatment in the past or present,
- 135< SBP< 145 or 85<DBP<95,
- Informed consent signed,
Who cannot join
- 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..),
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Different Doses of Tomato Lycopene on the Blood Pressure in Prehypertensives and Grade I Never Treated Otherwise Healthy Subjects
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.
- Conditions
- Hypertension
- Being tested
- Lyc-O-Mato 5mg, Lyc-O-Mato 15mg, Lyc-O-Mato 30mg, Lycopene capsules (non Lyc-o-mato) 15 mg, Placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
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
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).
PlaceboOther
Placebo capsules, identical looking to previous capsules for double-blind treatment period (8 weeks) and single blind run-in (4 weeks).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Other: Placebo |
| 2 | Active comparator | Lyc-o-Mato 5mg Receives: Dietary Supplement: Lyc-O-Mato 5mg |
| 3 | Active comparator | Lyc-o-Mato 15mg Receives: Dietary Supplement: Lyc-O-Mato 15mg |
| 4 | Active comparator | Lyc-o-Mato 30mg Receives: Dietary Supplement: Lyc-O-Mato 30mg |
| 5 | Active comparator | Lycopene capsules (non Lyc-o-mato) 15 mg Receives: Dietary Supplement: Lycopene capsules (non Lyc-o-mato) 15 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Measured: Every 2 weeks (Overall 12 weeks )
Secondary outcomes (4)
Serum lycopene levels
Measured: Week 0,Week 12
Serum Phytofluene levels
Measured: Week 0,Week 12
Serum 8 isoprostane levels
Measured: Week 0,Week 12
Serum nitrite-nitrate levels
Measured: Week 0,Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2009
- Study completionJan 2011
Why it stopped: difficulty to enroll more subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- LycoRed Ltd., The S. Daniel Abraham International Center for Health and Nutrition
- Responsible party
- Sponsor
- Investigators
- Ester Paran, Professor, Principal investigator, Hypertension clinic of the Soroka University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00637858
- Sponsor's protocol ID
- SOR459407CTIL
- Status last verified
- Jul 2009
- First submitted
- 11 Mar 2008
- Last updated
- 8 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1016/j.ahj.2005.05.008.
PubMed 16368299
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Doses of Tomato Lycopene on the Blood Pressure in Prehypertensives and Grade I Never Treated Otherwise Healthy Subjects
- ClinicalTrials.gov ID
- NCT00637858
- Acronym / sponsor ID
- SOR459407CTIL
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty to enroll more subjects
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Collaborators
- LycoRed Ltd., The S. Daniel Abraham International Center for Health and Nutrition
- Study start
- Oct 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 18 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Other: Placebo |
| 2 | Active comparator | Dietary Supplement: Lyc-O-Mato 5mgLyc-o-Mato 5mg |
| 3 | Active comparator | Dietary Supplement: Lyc-O-Mato 15mgLyc-o-Mato 15mg |
| 4 | Active comparator | Dietary Supplement: Lyc-O-Mato 30mgLyc-o-Mato 30mg |
| 5 | Active comparator | Dietary Supplement: Lycopene capsules (non Lyc-o-mato) 15 mgLycopene capsules (non Lyc-o-mato) 15 mg |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged 35-60,
- No antihypertensive treatment in the past or present,
- 135< SBP< 145 or 85<DBP<95,
- Informed consent signed,
Key exclusion criteria (22 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lyc-O-Mato 5mgDaily 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 | 2 |
| Lyc-O-Mato 15mgDaily 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 | 3 |
| Lyc-O-Mato 30mgDaily 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 | 4 |
| Lycopene capsules (non Lyc-o-mato) 15 mgDaily Lycopene capsules (non Lyc-o-mato) 15 mg with lunch for 8 weeks (After 4 weeks of placebo run in). | Dietary supplement | 5 |
| PlaceboPlacebo capsules, identical looking to previous capsules for double-blind treatment period (8 weeks) and single blind run-in (4 weeks). | Other | 1 |
Primary outcome
Blood Pressure
Time frame: Every 2 weeks (Overall 12 weeks )
4 secondary outcomes
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
Results and safety
The study was stopped early (reason given: difficulty to enroll more subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2013.
- Background: PubMed 16368299Engelhard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ester Paran, Professor principal investigator
Hypertension clinic of the Soroka University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lyc-O-Mato 5mg, Lyc-O-Mato 15mg and Lyc-O-Mato 30mg in people with Hypertension, run by Soroka University Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: difficulty to enroll more subjects). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: Every 2 weeks (Overall 12 weeks )). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00637858, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2013.