HypercholesterolemiaNCT02689934
Efficacy of a Red Yeast Rice Based Nutraceutical Plus Probiotic in Patients With Moderate Hypercholesterolemia
A study testing Lactoflorene colesterolo in people with Hypercholesterolemia, run by Montefarmaco OTC SpA at 1 site in Italy.
Trial summary
A randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy of a red yeast rice based nutraceutical (monacolin K 10 mg/dose) plus probiotic (Bifidobacterium longum BB536 ®), versus placebo, in patients with moderate hypercholesterolemia, in terms of improvement of the lipid profile and… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Lactoflorene colesterolo
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2016to 9 Mar 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 ≤ men or women ≤ 70
- men or female. Female must be postmenopausal or surgically sterile
- 130 mg/dl ≤ LDL-C ≤ 200 mg/dl
- patients in primary cardiovascular prevention
Who cannot join
- pregnancy and lactating
- patients with chronic diseases
- patients with serious hepatic diseases
- patients with serious renal diseases
- patients with thyroid diseases
- diabetes mellitus or glycemia >126 mg/dl
Show all 10Show fewer
- uncontrolled or severe hypertension
- obesity(BMI>30)
- smoking status
- drug or nutraceutical that can interfere with the experimental treatment
Trial locations and contacts
1 site in 1 country.
Italy1 site
Centro Dislipidemie Dip. Cardiotoracovasc ASST Grande Ospedale Metropolitano Niguarda Cà Granda
Milan, Mi, 20162
About this study
Official title: Efficacy of Red Yeast Rice Based Nutraceutical (Monacolin K 10 mg/Dose) Plus Probiotic (Bifidobacterium Longum BB536 ®) in Patients With Moderate Hypercholesterolemia.
A randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy of a red yeast rice based nutraceutical (monacolin K 10 mg/dose) plus probiotic (Bifidobacterium longum BB536 ®), versus placebo, in patients with moderate hypercholesterolemia, in terms of improvement of the lipid profile and cardiovascular risk.
- Conditions
- Hypercholesterolemia
- Being tested
- Lactoflorene colesterolo, Placebo lactoflorene colesterolo
- Keywords
- hypercholesterolemia, bifidobacterium longum BB536, red yeast rice, monacolin K, lactoflorene colesterolo
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactoflorene colesteroloDietary supplement
1.8 g + 1.8 g once a day per os
Placebo lactoflorene colesteroloDietary supplement
1.8 g + 1.8 g once a day per os
| Study group | Role | What they receive |
|---|---|---|
| Lactoflorene colesterolo | Experimental | Red Yeast Rice titrated in 10 mg monacolin K per daily dose plus Bifidobacterium longum 50 mg, powder form, 1 packet per day Receives: Dietary Supplement: Lactoflorene colesterolo |
| Placebo Lactoflorene colesterolo | Placebo comparator | placebo, powder form, 1 packet per day Receives: Dietary Supplement: Placebo lactoflorene colesterolo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in LDL-C From Baseline
Percent change from baseline in LDL-C after 12 weeks of treatment in patients with moderate hypercholesterolemia
Measured: 12 weeks
Secondary outcomes (3)
Safety and tolerability of Lactoflorene colesterolo (Incidence of treatment-related adverse events)
Incidence of treatment-related adverse events
Measured: 12 weeks
Changes in Other Lipids (non HDL-C, TG, HDL-C) and Apolipoproteins
Measured: 12 weeks
Changes in Vital Signs
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 posted24 Feb 2016 (estimated)
- Study startApr 2016
- Primary completion21 Feb 2017
- Study completion9 Mar 2017
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefarmaco OTC SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giuliana G Mombelli, MD, Principal investigator, ASST Grande Ospedale Metropolitano Niguarda Cà Granda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02689934
- Sponsor's protocol ID
- PROBIOTICO - BB536
- Status last verified
- Mar 2019
- First submitted
- 9 Feb 2016
- Last updated
- 14 Mar 2019
- Results posted
- No
- Individual data sharing
- No
Publications
Ruscica M, Pavanello C, Gandini S, Macchi C, Botta M, Dall'Orto D, Del Puppo M, Bertolotti M, Bosisio R, Mombelli G, Sirtori CR, Calabresi L, Magni P. Nutraceutical approach for the management of cardiovascular risk - a combination containing the probiotic Bifidobacterium longum BB536 and red yeast rice extract: results from a randomized, double-blind, placebo-controlled study. Nutr J. 2019 Feb 22;18(1):13. doi: 10.1186/s12937-019-0438-2.
PubMed 30795775
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Red Yeast Rice Based Nutraceutical (Monacolin K 10 mg/Dose) Plus Probiotic (Bifidobacterium Longum BB536 ®) in Patients With Moderate Hypercholesterolemia.
- ClinicalTrials.gov ID
- NCT02689934
- Acronym / sponsor ID
- PROBIOTICO - BB536
- Conditions
- Hypercholesterolemia
- Keywords
- hypercholesterolemia, bifidobacterium longum BB536, red yeast rice, monacolin K, lactoflorene colesterolo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Montefarmaco OTC SpAIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- 21 Feb 2017 (actual)
- Study completion
- 9 Mar 2017 (actual)
- First posted
- 24 Feb 2016 (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 randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy of a red yeast rice based nutraceutical (monacolin K 10 mg/dose) plus probiotic (Bifidobacterium longum BB536 ®), versus placebo, in patients with moderate hypercholesterolemia, in terms of improvement of the lipid profile and cardiovascular risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactoflorene colesterolo | Experimental | Dietary Supplement: Lactoflorene colesteroloRed Yeast Rice titrated in 10 mg monacolin K per daily dose plus Bifidobacterium longum 50 mg, powder form, 1 packet per day |
| Placebo Lactoflorene colesterolo | Placebo comparator | Dietary Supplement: Placebo lactoflorene colesteroloplacebo, powder form, 1 packet per day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 ≤ men or women ≤ 70
- men or female. Female must be postmenopausal or surgically sterile
- 130 mg/dl ≤ LDL-C ≤ 200 mg/dl
- patients in primary cardiovascular prevention
Key exclusion criteria (10 listed)
- pregnancy and lactating
- patients with chronic diseases
- patients with serious hepatic diseases
- patients with serious renal diseases
- patients with thyroid diseases
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 |
|---|---|---|
| Lactoflorene colesterolo1.8 g + 1.8 g once a day per os | Dietary supplement | Lactoflorene colesterolo |
| Placebo lactoflorene colesterolo1.8 g + 1.8 g once a day per os | Dietary supplement | Placebo Lactoflorene colesterolo |
Primary outcome
Percent Change in LDL-C From Baseline
Time frame: 12 weeks
Percent change from baseline in LDL-C after 12 weeks of treatment in patients with moderate hypercholesterolemia
3 secondary outcomes
Safety and tolerability of Lactoflorene colesterolo (Incidence of treatment-related adverse events)
Time frame: 12 weeks
Changes in Other Lipids (non HDL-C, TG, HDL-C) and Apolipoproteins
Time frame: 12 weeks
Changes in Vital Signs
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 14 Mar 2019.
- Results publication: PubMed 30795775Ruscica M, Pavanello C, Gandini S, Macchi C, Botta M, Dall'Orto D, Del Puppo M, Bertolotti M, Bosisio R, Mombelli G, Sirtori CR, Calabresi L, Magni P. Nutraceutical approach for the management of cardiovascular risk - a combination containing the probiotic Bifidobacterium longum BB536 and red yeast rice extract: results from a randomized, double-blind, placebo-controlled study. Nutr J. 2019 Feb 22;18(1):13. doi: 10.1186/s12937-019-0438-2.
- Related InfoLink provided by the sponsor.
- 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.
Giuliana G Mombelli, MD principal investigator
ASST Grande Ospedale Metropolitano Niguarda Cà Granda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactoflorene colesterolo in people with Hypercholesterolemia, run by Montefarmaco OTC SpA 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 10 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 14 Mar 2019. 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?
Percent Change in LDL-C From Baseline (time frame: 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 NCT02689934, 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 14 Mar 2019.