HypercholesterolemiaNCT02603276
Lipid-lowering Effect of Phytosterols, Red Yeast Rice and Their Combination
A study testing Plant sterols, Red Yeast Rice and Red Yeast Rice plus Plant sterols 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 phytosterols and red yeast rice. 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 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?
- Plant sterols, Red Yeast Rice and Red Yeast Rice plus Plant sterols
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2015to Dec 2015
- 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
- LDL-cholesterolemia between 130 and 190 mg/dL
Who cannot join
- Type 2 diabetes
- Previous cardiovascular disease
- Assumption of lipid-lowering drugs or dietary supplements
- Previous intolerance to red yeast rice
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lipid-lowering Effect of Phytosterols, Red Yeast Rice and Their Combination in Moderately Hypercholesterolemic Subjects in Primary Prevention for Cardiovascular Diseases: a Randomized, Double Blind, Clinical Trial
A large body of evidence confirm the cholesterol lowering effect of phytosterols and red yeast rice. 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
A large body of literature suggest that the patients are strongly interested in self-medicating them with "natural" products aimed at reducing their plasma level of LDL-cholesterol. Plant sterols and red yeast rice are among the most widely marketed product with these properties in Western countries. However plant sterols per se have a limited effect on cholesterolemia, while full dosed red yeast rice can induce myalgias and myopathies as statins do. In this context, the aim of the investigators' study was to evaluate if the association of both products at low dosage could induce an additive or synergistic effect in term of LDL-reduction in humans.
- Conditions
- Hypercholesterolemia
- Being tested
- Plant sterols, Red Yeast Rice, Red Yeast Rice plus Plant sterols
- Keywords
- hypercholesterolemia, dietary supplements, red yeast rice, plant sterols
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant sterolsDietary supplement
Plant sterols 800 mg/dose, 1 liquid stick per day, for 8 weeks
Red Yeast RiceDietary supplement
Red Yeast Rice titrated in 5 mg monacolin K per daily dose, 1 liquid stick per day, for 8 weeks
Red Yeast Rice plus Plant sterolsDietary supplement
Red Yeast Rice titrated in 5 mg monacolin K per daily dose plus Plant sterols 800 mg/dose, together in 1 liquid stick per day, for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Plant sterols | Active comparator | Plant sterols 800 mg per dose, 1 liquid stick per day, per 8 weeks Receives: Dietary Supplement: Plant sterols |
| Red Yeast Rice | Active comparator | Red Yeast Rice 200 mg containing 5 mg monacolin K per daily dose, 1 liquid stick per day, per 8 weeks Receives: Dietary Supplement: Red Yeast Rice |
| Red Yeast Rice plus Plant sterols | Experimental | lant sterols 800 mg per dose + Red Yeast Rice 200 mg containing 5 mg monacolin K per daily dose, 1 liquid stick per day, per 8 weeks Receives: Dietary Supplement: Plant sterols; Dietary Supplement: Red Yeast Rice plus Plant sterols |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL cholesterolemia reduction from baseline and between groups
Absolute and % reduction of LDL cholesterolemia after 8 weeks of treatment
Measured: 8 weeks
Secondary outcomes (2)
Non-HDL cholesterolemia reduction from baseline and between groups
Absolute and % reduction of of non-HDL cholesterolemia after 8 weeks of treatment
Measured: 8 weeks
Number of Participants With Treatment-Related Adverse Events
Subjective tolerability of the tested 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 posted11 Nov 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2015
- Study completionDec 2015
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 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
- 60 participants (estimated)
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, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02603276
- Sponsor's protocol ID
- PhytoRed
- Status last verified
- Jan 2024
- First submitted
- 27 Aug 2015
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Cicero AFG, Fogacci F, Rosticci M, Parini A, Giovannini M, Veronesi M, D'Addato S, Borghi C. Effect of a short-term dietary supplementation with phytosterols, red yeast rice or both on lipid pattern in moderately hypercholesterolemic subjects: a three-arm, double-blind, randomized clinical trial. Nutr Metab (Lond). 2017 Sep 25;14:61. doi: 10.1186/s12986-017-0214-2. eCollection 2017.
PubMed 29021813
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipid-lowering Effect of Phytosterols, Red Yeast Rice and Their Combination in Moderately Hypercholesterolemic Subjects in Primary Prevention for Cardiovascular Diseases: a Randomized, Double Blind, Clinical Trial
- ClinicalTrials.gov ID
- NCT02603276
- Acronym / sponsor ID
- PhytoRed
- Conditions
- Hypercholesterolemia
- Keywords
- hypercholesterolemia, dietary supplements, red yeast rice, plant sterols
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 11 Nov 2015 (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.
A large body of evidence confirm the cholesterol lowering effect of phytosterols and red yeast rice. 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
A large body of literature suggest that the patients are strongly interested in self-medicating them with "natural" products aimed at reducing their plasma level of LDL-cholesterol. Plant sterols and red yeast rice are among the most widely marketed product with these properties in Western countries. However plant sterols per se have a limited effect on cholesterolemia, while full dosed red yeast rice can induce myalgias and myopathies as statins do. In this context, the aim of the investigators' study was to evaluate if the association of both products at low dosage could induce an additive or synergistic effect in term of LDL-reduction in humans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Plant sterols | Active comparator | Dietary Supplement: Plant sterolsPlant sterols 800 mg per dose, 1 liquid stick per day, per 8 weeks |
| Red Yeast Rice | Active comparator | Dietary Supplement: Red Yeast RiceRed Yeast Rice 200 mg containing 5 mg monacolin K per daily dose, 1 liquid stick per day, per 8 weeks |
| Red Yeast Rice plus Plant sterols | Experimental | Dietary Supplement: Plant sterols, Dietary Supplement: Red Yeast Rice plus Plant sterolslant sterols 800 mg per dose + Red Yeast Rice 200 mg containing 5 mg monacolin K per daily dose, 1 liquid stick per day, per 8 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- LDL-cholesterolemia between 130 and 190 mg/dL
Key exclusion criteria (4 listed)
- Type 2 diabetes
- Previous cardiovascular disease
- Assumption of lipid-lowering drugs or dietary supplements
- Previous intolerance to red yeast rice
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 |
|---|---|---|
| Plant sterolsPlant sterols 800 mg/dose, 1 liquid stick per day, for 8 weeks | Dietary supplement | Plant sterols, Red Yeast Rice plus Plant sterols |
| Red Yeast RiceRed Yeast Rice titrated in 5 mg monacolin K per daily dose, 1 liquid stick per day, for 8 weeks | Dietary supplement | Red Yeast Rice |
| Red Yeast Rice plus Plant sterolsRed Yeast Rice titrated in 5 mg monacolin K per daily dose plus Plant sterols 800 mg/dose, together in 1 liquid stick per day, for 8 weeks | Dietary supplement | Red Yeast Rice plus Plant sterols |
Primary outcome
LDL cholesterolemia reduction from baseline and between groups
Time frame: 8 weeks
Absolute and % reduction of LDL cholesterolemia after 8 weeks of treatment
2 secondary outcomes
Non-HDL cholesterolemia reduction from baseline and between groups
Time frame: 8 weeks
Number of Participants With Treatment-Related Adverse Events
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 1 Feb 2024.
- Results publication: PubMed 29021813Cicero AFG, Fogacci F, Rosticci M, Parini A, Giovannini M, Veronesi M, D'Addato S, Borghi C. Effect of a short-term dietary supplementation with phytosterols, red yeast rice or both on lipid pattern in moderately hypercholesterolemic subjects: a three-arm, double-blind, randomized clinical trial. Nutr Metab (Lond). 2017 Sep 25;14:61. doi: 10.1186/s12986-017-0214-2. eCollection 2017.
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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.
Claudio Borghi, MD principal investigator
University of Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant sterols, Red Yeast Rice and Red Yeast Rice plus Plant sterols 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 1 inclusion and 4 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 1 Feb 2024. 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?
LDL cholesterolemia reduction from baseline and between groups (time frame: 8 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 NCT02603276, 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 1 Feb 2024.