PrehypertensionNCT01667510
Effect of Cardio Mato (Grade A Lyc-O-Mato, a Tomato Extracted Lycopene) on Blood Pressure
A study testing Cardio Mato in people with Prehypertension, run by LycoRed Ltd. at 1 site in Israel.
Trial summary
The hypothesis of the study is that supplementation with Cardio Mato (a Tomato Extracted Lycopene)for 12 weeks will decrease the blood pressure of subjects with prehypertension compared to Placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Prehypertension
- What is being tested?
- Cardio Mato
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2012to Aug 2013
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects aged 18-65, both inclusive
- Established Pre-hypertension defined as: Mean baseline SBP 130-139 mmHg and DBP of 89 mmHg or lower or SBP of 139 mmHg or lower and DBP of 85- 89 mmHg, at screening, eligibility and randomization visits
- Subjects that did not receive any antihypertensive treatment in the past o present
- Subjects that are willing to sign an informed consent form prior to joining the study
Who cannot join
- Subjects with Mean baseline SBP higher than 120 and lower than 130 mmHg
- Subjects with Mean baseline DBP higher than 80 and lower than 85 mmHg
- Subjects who are treated for blood pressure reduction (any treatment)
- Subjects under treatment with other chronic medications (e.g. statins, NSAID etc.)
- Subjects that use antioxidant agents or vitamins within 4 weeks prior to inclusion into the study
- Subjects that will not be able to follow the study dietary proscriptions from the screening visit through the final visit
Show all 20Show fewer
- Subjects following any special diet including, but not limited to liquid, high or low protein, raw food, vegetarian or vegan, etc
- Subjects with known allergy to tomatoes, carotenoids, or vitamin E
- Subjects diagnosed with Diabetes Mellitus
- Subjects suffering from obesity
- Subjects Suffering from a clinically significant dyslipidaemia
- Subjects suffering from cardiac disease; e.g. suffering from cardiac angina, subjects that were diagnosed with and MI, subjects that needed PTCA or CABG. Subjects diagnosed with LVH, CHF or valvular heart disease
- Subjects diagnosed with PVD
- Subjects who were diagnosed with Cerebrovascular disease, s/p CVA, TIA
- Subjects who suffer from any kind of kidney disease
- Subjects who suffer from chronic liver disease; defined as elevated AST and ALT at least by 2 times of the normal range
- Subject with history or current use of illegal or "recreational" drugs
- Subjects with a history of GI disease or surgery within 6 months prior to study inclusion
- Subjects with a history of malignancy in the past 5 years
- Subjects with a history of autoimmune disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Cardio Mato (Grade A Lyc-O-Mato, a Tomato Extracted Lycopene) on Blood Pressure and Serum Lycopene, Phytofluene, and Phytoene Levels in Pre-hypertensive Otherwise Healthy Subjects
The hypothesis of the study is that supplementation with Cardio Mato (a Tomato Extracted Lycopene)for 12 weeks will decrease the blood pressure of subjects with prehypertension compared to Placebo.
Read the detailed description
Blood-pressure reading of 140/90 mmHg (systolic/diastolic pressure) are typically regarded as having high blood pressure as defined in the most recent guidelines. From a physiological perspective, the regulation of blood pressure is a complicated process involving different biological systems and a number of feedback systems, including the nervous system, hormones, control of body fluid and regulators within the vessels themselves. In 90-95% of patients with high blood pressure the cause is unknown, whereas the remaining 5-10% may have secondary hypertension related to congenital heart defects, certain cancers or kidney abnormalities. Prehypertension [systolic blood pressure (SBP) 120-139 mm Hg, diastolic blood pressure (DBP) 80-89 mm Hg] is considered a precursor of hypertension and has been associated with an increased risk of up to 3.5 times in cardiovascular morbidity and mortality later in life.
According the report of the Joint National Committee on High Blood Pressure (JNC 7) and other international guidelines, weight control, reduced intake of salt and reduced alcohol consumption, as well as increase of potassium are recommend nutritional approaches to prevent and treat hypertension. In observational studies significant inverse association between high blood pressure and vegetarian diet rich in fibers, magnesium, potassium, calcium and protein have been reported. In addition various studies demonstrated the ability of antioxidant vitamins of natural origin to improve vascular function.
- Conditions
- Prehypertension
- Being tested
- Cardio Mato, Placebo
- Keywords
- Prehypertension, anti oxidation, lycopene
- Medical subject headings
- Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardio MatoDietary supplement
Soft gel capsule for oral use
PlaceboDietary supplement
Soft gel capsule without test material
| Study group | Role | What they receive |
|---|---|---|
| Cardio Mato | Experimental | Soft gel capsule for oral use (Grade A Lyc-O-Mato, a tomato extracted lycopene) Receives: Dietary Supplement: Cardio Mato |
| Placebo | Placebo comparator | Soft gel capsule without test material, for oral use Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect Lyc-O-Mato on the blood pressure of pre-hypertensive otherwise healthy subjects compared to the placebo group following 12 weeks of treatment
Change in blood pressure from baseline to 12 weeks in mmHG
Measured: 12 weeks
Secondary outcomes (2)
The effect Cardio Mato on the blood pressure of Pre-hypertensive otherwise healthy subjects compared to the placebo group following 4 and 8 weeks of treatment
Change in blood pressure from baseline to 4 and 8 weeks in mmHG
Measured: 4-8 weeks
The correlation between B.P changes in the Cardio Mato or placebo treatment arms during the study with serum lycopene phytofluene, and phytoene levels
B.P change
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrehypertensionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- LycoRed Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Maccabi Healthcare Services, Israel
- Responsible party
- Sponsor
- Investigators
- Arnon Aharon, MD., Study director, LycoRed Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01667510
- Sponsor's protocol ID
- Lyc-2012-01
- Status last verified
- Aug 2012
- First submitted
- 12 Aug 2012
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cardio Mato (Grade A Lyc-O-Mato, a Tomato Extracted Lycopene) on Blood Pressure and Serum Lycopene, Phytofluene, and Phytoene Levels in Pre-hypertensive Otherwise Healthy Subjects
- ClinicalTrials.gov ID
- NCT01667510
- Acronym / sponsor ID
- Lyc-2012-01
- Conditions
- Prehypertension
- Keywords
- Prehypertension, anti oxidation, lycopene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- LycoRed Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Maccabi Healthcare Services, Israel
- Study start
- Aug 2012 (actual)
- Primary completion
- Jun 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 17 Aug 2012 (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.
The hypothesis of the study is that supplementation with Cardio Mato (a Tomato Extracted Lycopene)for 12 weeks will decrease the blood pressure of subjects with prehypertension compared to Placebo.
Detailed description
Blood-pressure reading of 140/90 mmHg (systolic/diastolic pressure) are typically regarded as having high blood pressure as defined in the most recent guidelines. From a physiological perspective, the regulation of blood pressure is a complicated process involving different biological systems and a number of feedback systems, including the nervous system, hormones, control of body fluid and regulators within the vessels themselves. In 90-95% of patients with high blood pressure the cause is unknown, whereas the remaining 5-10% may have secondary hypertension related to congenital heart defects, certain cancers or kidney abnormalities. Prehypertension [systolic blood pressure (SBP) 120-139 mm Hg, diastolic blood pressure (DBP) 80-89 mm Hg] is considered a precursor of hypertension and has been associated with an increased risk of up to 3.5 times in cardiovascular morbidity and mortality later in life.
According the report of the Joint National Committee on High Blood Pressure (JNC 7) and other international guidelines, weight control, reduced intake of salt and reduced alcohol consumption, as well as increase of potassium are recommend nutritional approaches to prevent and treat hypertension. In observational studies significant inverse association between high blood pressure and vegetarian diet rich in fibers, magnesium, potassium, calcium and protein have been reported. In addition various studies demonstrated the ability of antioxidant vitamins of natural origin to improve vascular function.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardio Mato | Experimental | Dietary Supplement: Cardio MatoSoft gel capsule for oral use (Grade A Lyc-O-Mato, a tomato extracted lycopene) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSoft gel capsule without test material, for oral use |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female subjects aged 18-65, both inclusive
- Established Pre-hypertension defined as: Mean baseline SBP 130-139 mmHg and DBP of 89 mmHg or lower or SBP of 139 mmHg or lower and DBP of 85- 89 mmHg, at screening, eligibility and randomization visits
- Subjects that did not receive any antihypertensive treatment in the past o present
- Subjects that are willing to sign an informed consent form prior to joining the study
Key exclusion criteria (20 listed)
- Subjects with Mean baseline SBP higher than 120 and lower than 130 mmHg
- Subjects with Mean baseline DBP higher than 80 and lower than 85 mmHg
- Subjects who are treated for blood pressure reduction (any treatment)
- Subjects under treatment with other chronic medications (e.g. statins, NSAID etc.)
- Subjects that use antioxidant agents or vitamins within 4 weeks prior to inclusion into the study
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 |
|---|---|---|
| Cardio MatoSoft gel capsule for oral use | Dietary supplement | Cardio Mato |
| PlaceboSoft gel capsule without test material | Dietary supplement | Placebo |
Primary outcome
The effect Lyc-O-Mato on the blood pressure of pre-hypertensive otherwise healthy subjects compared to the placebo group following 12 weeks of treatment
Time frame: 12 weeks
Change in blood pressure from baseline to 12 weeks in mmHG
2 secondary outcomes
The effect Cardio Mato on the blood pressure of Pre-hypertensive otherwise healthy subjects compared to the placebo group following 4 and 8 weeks of treatment
Time frame: 4-8 weeks
The correlation between B.P changes in the Cardio Mato or placebo treatment arms during the study with serum lycopene phytofluene, and phytoene levels
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
- Data on tomato extracted lycopeneLink provided by the sponsor.
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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.
Arnon Aharon, MD. study director
LycoRed Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardio Mato in people with Prehypertension, run by LycoRed Ltd. 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 20 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: finished, as of the sponsor's last update on 22 Dec 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The effect Lyc-O-Mato on the blood pressure of pre-hypertensive otherwise healthy subjects compared to the placebo group following 12 weeks of treatment (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Dec 2017.