HypercholesterolemiaMALTRONCT04433429
Nutraceuticals and Vascular Remodelling
An observational study of Hypercholesterolemia, run by Marcello Rattazzi at 1 site in Italy.
Trial summary
Aim of the study is to assess the effect of a long-term nutraceutical multitarget approach on lipid profile, inflammatory mediators and vascular remodeling in primary cardiovascular prevention in a setting of controlled dietary habits. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Liposcudil Plus
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- May 2016to Dec 2017
- Phase
- Observational
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with mild hypercholeterolemia and low-to moderate cardiovascular risk profile
Who may be able to join
- Total Cholesterol > 150 mg/dl and < 250 mg/dl;
- Triglycerides > 150 mg/dl and < 500 mg/dl;
- Fasting glucose < 126 mg/dl;
- Stable antihypertensive treatment (at least for 6 months) in presence of hypertension.
Who cannot join
- Total Cholesterol > 250 mg/dl
- Triglycerides > 500 mg/dl
- Previous statin therapy (last 6 months);
- Treatment with hypoglycemic agents and/or fasting glucose > 126 mg/dl;
- Chronic gastrointestinal disorders;
- Chronic kidney disease (eGFR < 60 ml/min/1.73 m2);
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- Concomitant treatment with drugs potentially interfering with glucose and lipid metabolism; - History of cardiovascular diseases;
- Proven intolerance to any component of the nutraceutical product;
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lipid Profile and Vascular Remodelling in Young Dyslipidemic Subjects Treated With Nutraceuticals Derived From Red Yeast Rice.
Aim of the study is to assess the effect of a long-term nutraceutical multitarget approach on lipid profile, inflammatory mediators and vascular remodeling in primary cardiovascular prevention in a setting of controlled dietary habits. The nutraceutical combination used in this study consists of a single pill containing 333 mg of RYR, equivalent to 10 mg of Monacolin K, and 30 mg of Coenzyme Q10 (CoQ10).
- Conditions
- Hypercholesterolemia
- Being tested
- Liposcudil Plus
- Keywords
- Atherosclerosis, Carotid, Lipid profile
- Medical subject headings
- Hypercholesterolemia, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposcudil PlusDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| RYR plus CoQ | 333 mg of red yeast rice (RYR, equivalent to 10 mg of Monacolin K) plus 30 mg of Coenzyme Q10 (CoQ10) in a single pill once daily Receives: Dietary Supplement: Liposcudil Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in cholesterol levels at one year
Total Cholesterol will be measured in the blood sample from each patient and expressed as mg/dl
Measured: Baseline and one year
Change from baseline in carotid intima media thickening at one year
Carotid ultrasound examination is performed at baseline and after one year to measure intima-media thickness (IMT). IMT is defined as the distance in mm between the lumen-intima and the media-adventitia interfaces, it is measured at end diastole in the far wall of the right and left sides of the common carotid artery, the bulb and the internal carotid artery. Carotid IMT measurements are expressed as cumulative mean of mean-IMT (m-IMT) recorded in each vascular segment .
Measured: Baseline and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study startMay 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marcello Rattazzi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marcello Rattazzi, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433429
- Sponsor's protocol ID
- 3497/AO/15
- Acronym
- MALTRO
- Status last verified
- Jun 2020
- First submitted
- 10 Jun 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipid Profile and Vascular Remodelling in Young Dyslipidemic Subjects Treated With Nutraceuticals Derived From Red Yeast Rice.
- ClinicalTrials.gov ID
- NCT04433429
- Acronym / sponsor ID
- MALTRO / 3497/AO/15
- Conditions
- Hypercholesterolemia
- Keywords
- Atherosclerosis, Carotid, Lipid profile
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Marcello RattazziUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 16 Jun 2020 (actual)
- 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.
Aim of the study is to assess the effect of a long-term nutraceutical multitarget approach on lipid profile, inflammatory mediators and vascular remodeling in primary cardiovascular prevention in a setting of controlled dietary habits. The nutraceutical combination used in this study consists of a single pill containing 333 mg of RYR, equivalent to 10 mg of Monacolin K, and 30 mg of Coenzyme Q10 (CoQ10).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RYR plus CoQ | – | Dietary Supplement: Liposcudil Plus333 mg of red yeast rice (RYR, equivalent to 10 mg of Monacolin K) plus 30 mg of Coenzyme Q10 (CoQ10) in a single pill once daily |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with mild hypercholeterolemia and low-to moderate cardiovascular risk profile
Key inclusion criteria (4 listed)
- Total Cholesterol > 150 mg/dl and < 250 mg/dl;
- Triglycerides > 150 mg/dl and < 500 mg/dl;
- Fasting glucose < 126 mg/dl;
- Stable antihypertensive treatment (at least for 6 months) in presence of hypertension.
Key exclusion criteria (9 listed)
- Total Cholesterol > 250 mg/dl
- Triglycerides > 500 mg/dl
- Previous statin therapy (last 6 months);
- Treatment with hypoglycemic agents and/or fasting glucose > 126 mg/dl;
- Chronic gastrointestinal disorders;
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 |
|---|---|---|
| Liposcudil Plus | Dietary supplement | RYR plus CoQ |
Primary outcome
Change from baseline in cholesterol levels at one year
Time frame: Baseline and one year
Total Cholesterol will be measured in the blood sample from each patient and expressed as mg/dl
Change from baseline in carotid intima media thickening at one year
Time frame: Baseline and one year
Carotid ultrasound examination is performed at baseline and after one year to measure intima-media thickness (IMT). IMT is defined as the distance in mm between the lumen-intima and the media-adventitia interfaces, it is measured at end diastole in the far wall of the right and left sides of the common carotid artery, the bulb and the internal carotid artery. Carotid IMT measurements are expressed as cumulative mean of mean-IMT (m-IMT) recorded in each vascular segment .
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 16 Jun 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesterolemia, run by Marcello Rattazzi at 1 site in Italy.
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 9 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 16 Jun 2020. 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 Italy. 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. 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?
Change from baseline in cholesterol levels at one year (time frame: Baseline and one year). The study lists 2 primary outcomes in all. 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 16 Jun 2020.