HypercholesterolemiaNCT03065491
Effect of Red Yeast Rice, Phytosterols and L-tyrosol on Lipid Profile and Endothelial Function
A study testing Combined nutraceutical in people with Hypercholesterolemia, run by University of Bologna at 1 site in Italy.
Trial summary
A large body of evidence confirm the cholesterol lowering effect of red yeast rice, phytosterols and L-tyrosol. Because their mechanisms of action mime the ones of chemical statins and cholesterol absorption inhibitors, it is plausible that their association will provide a more relevant (and safe) LDL cholesterolemia… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Combined nutraceutical
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 15 Nov 2016to 17 Feb 2017
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Suboptimal LDL level (115-160 mg/dL)
- TG<400 mg/dL
- Signed informed consent form
Who cannot join
- Patients already affected by cardiovascular diseases (secondary prevention) or with estimated 10 years cardiovascular disease risk> 10 years
- LDL-C<115 mg/dL or >160 mg/dL, TG>400 mg/dL
- Obesity (BMI>30 kg/m2) or diabetes mellitus
- Assumption of lipid lowering drugs or dietary supplements, or drugs potentially affecting the lipid metabolism
- Antihypertensive treatment not stabilized since at least 3 months
- Known current thyroid, gastrointestinal or liver diseases
- Any medical or surgical condition that would limit the patient adhesion to the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Red Yeast Rice, Phytosterols and L-tyrosol on Lipid Profile and Endothelial Function: a Double-blind, Placebo-controlled, Randomized Clinical Trial
A large body of evidence confirm the cholesterol lowering effect of red yeast rice, phytosterols and L-tyrosol. Because their mechanisms of action mime the ones of chemical statins and cholesterol absorption inhibitors, it is plausible that their association will provide a more relevant (and safe) LDL cholesterolemia reduction.
Read the detailed description
European Food Safety Authority approves some health claim related to the cardiometabolic effects of some nutraceuticals, and in particular of red yeast rice, phytosterols and L-tyrosol.
In a previous study the investigators have already demonstrated the synergistic effect of red yeast rice and phytosterols in term of lipid-lowering activity.
Preliminary data suggest that these nutraceuticals could also exert a positive effect on vascular health beyond the direct effects on serum lipids.
No data are available on the combined effects of these dietary supplement in humans.
- Conditions
- Hypercholesterolemia
- Being tested
- Combined nutraceutical, Placebo
- Keywords
- Red yeast rice, Phytosterols, L-Tyrosol, Lipids, LDL-cholesterol, Endothelial function
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined nutraceuticalDietary supplement
Plant sterols 800 mg + Red Yeast Rice containing 5 mg monacolin K + L-Tyrosol 50 mg per daily dose Oral administration: 1 tablet per day
PlaceboOther
Oral administration: 1 tablet per day
| Study group | Role | What they receive |
|---|---|---|
| Active treatment | Active comparator | Combined nutraceutical Receives: Dietary Supplement: Combined nutraceutical |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-cholesterolemia absolute reduction from baseline and between groups
Absolute reduction of LDL-cholesterolemia after 8 weeks of treatment
Measured: 8 weeks
LDL-cholesterolemia % reduction from baseline and between groups
% reduction of LDL-cholesterolemia after 8 weeks of treatment
Measured: 8 weeks
Secondary outcomes (1)
Flow-mediated dilation improvement from baseline and between groups
% vascular heath improvement after 8 weeks of treatment
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study start15 Nov 2016
- Primary completion15 Feb 2017
- Study completion17 Feb 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudio Borghi, University of Bologna
- Investigators
- Claudio Borghi, MD, Principal investigator, S. Orsola-Malpighi University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03065491
- Sponsor's protocol ID
- MPT_trial_2016
- Status last verified
- Feb 2017
- First submitted
- 15 Feb 2017
- Last updated
- 28 Feb 2017
- 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 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Red Yeast Rice, Phytosterols and L-tyrosol on Lipid Profile and Endothelial Function: a Double-blind, Placebo-controlled, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03065491
- Acronym / sponsor ID
- MPT_trial_2016
- Conditions
- Hypercholesterolemia
- Keywords
- Red yeast rice, Phytosterols, L-Tyrosol, Lipids, LDL-cholesterol, Endothelial function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 15 Nov 2016 (actual)
- Primary completion
- 15 Feb 2017 (actual)
- Study completion
- 17 Feb 2017 (actual)
- First posted
- 28 Feb 2017 (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.
A large body of evidence confirm the cholesterol lowering effect of red yeast rice, phytosterols and L-tyrosol. Because their mechanisms of action mime the ones of chemical statins and cholesterol absorption inhibitors, it is plausible that their association will provide a more relevant (and safe) LDL cholesterolemia reduction.
Detailed description
European Food Safety Authority approves some health claim related to the cardiometabolic effects of some nutraceuticals, and in particular of red yeast rice, phytosterols and L-tyrosol.
In a previous study the investigators have already demonstrated the synergistic effect of red yeast rice and phytosterols in term of lipid-lowering activity.
Preliminary data suggest that these nutraceuticals could also exert a positive effect on vascular health beyond the direct effects on serum lipids.
No data are available on the combined effects of these dietary supplement in humans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Active comparator | Dietary Supplement: Combined nutraceuticalCombined nutraceutical |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Suboptimal LDL level (115-160 mg/dL)
- TG<400 mg/dL
- Signed informed consent form
Key exclusion criteria (7 listed)
- Patients already affected by cardiovascular diseases (secondary prevention) or with estimated 10 years cardiovascular disease risk> 10 years
- LDL-C<115 mg/dL or >160 mg/dL, TG>400 mg/dL
- Obesity (BMI>30 kg/m2) or diabetes mellitus
- Assumption of lipid lowering drugs or dietary supplements, or drugs potentially affecting the lipid metabolism
- Antihypertensive treatment not stabilized since at least 3 months
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 |
|---|---|---|
| Combined nutraceuticalPlant sterols 800 mg + Red Yeast Rice containing 5 mg monacolin K + L-Tyrosol 50 mg per daily dose Oral administration: 1 tablet per day | Dietary supplement | Active treatment |
| PlaceboOral administration: 1 tablet per day | Other | Placebo |
Primary outcome
LDL-cholesterolemia absolute reduction from baseline and between groups
Time frame: 8 weeks
Absolute reduction of LDL-cholesterolemia after 8 weeks of treatment
LDL-cholesterolemia % reduction from baseline and between groups
Time frame: 8 weeks
% reduction of LDL-cholesterolemia after 8 weeks of treatment
1 secondary outcome
Flow-mediated dilation improvement from baseline and between groups
Time frame: 8 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 28 Feb 2017.
- Individual participant dataSharing planned: No
Related trials for Hypercholesterolemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
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.
Claudio Borghi, MD principal investigator
S. Orsola-Malpighi 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 Combined nutraceutical in people with Hypercholesterolemia, run by University of Bologna 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 3 inclusion and 7 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 28 Feb 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 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. 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?
LDL-cholesterolemia absolute reduction from baseline and between groups (time frame: 8 weeks). 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 28 Feb 2017.