Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000534684
Ethics application status
Approved
Date submitted
2/05/2023
Date registered
19/05/2023
Date last updated
10/05/2024
Date data sharing statement initially provided
19/05/2023
Date results information initially provided
10/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of natural product based on plants extract on cholesterol
Scientific title
Hypolipidemic effects of a novel neutracheutical containing monacolin K, combined with coenzyme Q10, policosanols, Bergamot and thistle extract in patients with mild dyslipidemia.
Secondary ID [1] 309568 0
Nil known
Universal Trial Number (UTN)
U1111-1292-0069
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hyperlipidemia 329870 0
cardiovascular disease 329871 0
Condition category
Condition code
Cardiovascular 326777 326777 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomsied, placebo controlled trial. One interventional arm and one placebo/comparator arm. Participants are randomised to treatment arm or placebo.The study is parallel in design.
Arm 1: Nutraceutical containing: Red Yeast Rice (equivalent to 2.8mg Monacolin K) + Bergamot dry extract 250mg+ 2g Plant Policozanol 24mg + thiest dry extract 16mg + coenzyme Q10 ,taken once daily for 8 weeks via oral tablets plus Mediterranean Diet Meal Plan
Arm 2: Nutraceutical Placebo once daily for 8 weeks via oral tablets and Mediterranean Diet Meal Plan
Compliance will be monitored via drug tablet return
For additional notes on placebo tablets, please see section below.
Intervention code [1] 325993 0
Treatment: Drugs
Comparator / control treatment
The placebo tablets will be identical in appearance to their active counterparts and contain microcrystalline cellulose.
Control group
Placebo

Outcomes
Primary outcome [1] 334630 0
Change in lipid profile (total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol and triglycerides) as assessed via fasting blood sample following a 12 hour fast.
Timepoint [1] 334630 0
Baseline, and 12 weeks after intervention commencement.
Secondary outcome [1] 421460 0
Development of side effects as assessed by plasma creatinine kinase measures as an indication of myopathy and liver enzymes ( ALT,AST,gamma-gt) as an indication of transaminassemia.
Timepoint [1] 421460 0
Basal and 12 weeks after treatment initiation

Eligibility
Key inclusion criteria
Patients are eligible to participate in the present study if they have mild hypercholesterolemia (fasting LDL-C concentration between 140 and 180 mg/dL) and no indication for statin treatment [10-year atherosclerotic cardiovascular disease risk (ASCVD Risk) < 7.5%]. The 10-year risk wil be calculated in all participants using the updated ASCVD Risk Estimator Plus (found in: https://tools.acc.org/ASCVD-Risk-Estimator-Plus/#!/calculate/estimate
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Use of lipid-lowering medications, such as statins, within 3 months prior to study enrollment, conditions which produce an increased ASCVD risk, such as diabetes mellitus, known atherosclerotic vascular disease, or moderate/severe renal insufficiency (Modification of Diet in Renal Disease calculated glomerular filtration rate, MDRD GFR < 60 mL/min), abnormal liver function tests, excessive alcohol intake, pregnancy, lactation or the use of oral contraceptives

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation via numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table generated by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The primary outcome is a reduction in LDL cholesterol. This will be assessed by intergroup comparison and by comparison of the two groups in the end of the study. All analysis will be performed at the completion of the trial. Participants who withdraw from the study will not be replaced. Sample size calculations are based on assumptions made on the primary outcome, reduction in LDL cholesterol levels. With 80 participants, this study is powered for a 0.8 mmol/L reduction in LDL (30mg) cholesterol. Previous studies with similar nutraceuticals have documented 15-25% reduction in LDL levels in patients with moderate increase in LDL levels when 3mg of monacolin K administrated. It is expected that the combination of monacolin with other substances with potential lipid-lowering effects will have additive effects on LDL reduction. The level of significance is p<0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/05/2023
Actual
31/05/2023
Date of last participant enrolment
Anticipated
30/06/2023
Actual
30/06/2023
Date of last data collection
Anticipated
31/08/2023
Actual
31/08/2023
Sample size
Target
80
Accrual to date
Final
80
Recruitment outside Australia
Country [1] 25426 0
Greece
State/province [1] 25426 0

Funding & Sponsors
Funding source category [1] 313757 0
Self funded/Unfunded
Name [1] 313757 0
Nicholaos Angelopoulos
Country [1] 313757 0
Greece
Primary sponsor type
Individual
Name
Nicholaos Angelopoulos,MD,Phd
Address
Private Office:Endocrine practice, Venizelou 26,Kavala,Greece,65403
Afiliation: Aristotle University of Thessaloniki,Medical School
Country
Greece
Secondary sponsor category [1] 315580 0
None
Name [1] 315580 0
Address [1] 315580 0
Country [1] 315580 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312928 0
Athens Medical Centre General Hospital,Athens,Greece
Ethics committee address [1] 312928 0
distomou 5-7, Athens, Greece, 15125
Ethics committee country [1] 312928 0
Greece
Date submitted for ethics approval [1] 312928 0
01/12/2022
Approval date [1] 312928 0
12/12/2022
Ethics approval number [1] 312928 0
01122022/100

Summary
Brief summary
The combination of nutraceuticals based on monacolin allows achieving LDL-C reductions by using lower doses of each component, and thus reduces the likelihood of adverse events re-lated to a single component. Nonetheless, because these supplements contain additional cholesterol-lowering agents, it is challenging to discern whether the lipid-lowering effect was primarily due to monacolin K or another agent.various studies assessing the effects of RYR food supplements containing monacolins yielded safety concerns when the dose of monacolin reached 10 mg/day. The aim of this study is to assess the lipid-lowering activity and safety of a novel, commercially available dietary supplement, containing low dose of monacolin (<3mg) combined with other plant derived ingredients in subjects with moderate elevations in LDL-C concentrations and low cardiovascular risk.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126370 0
Dr Nicholaos Angelopoulos, Endocrinologist,MD,Phd
Address 126370 0
Venizelou 26, Kavala,Greece,65403
Private Endocrine Unit
Country 126370 0
Greece
Phone 126370 0
+302510225200
Fax 126370 0
+302510830900
Email 126370 0
drangelnick@gmail.com
Contact person for public queries
Name 126371 0
Dr Nicholaos Angelopoulos, Endocrinologist,MD,Phd
Address 126371 0
Venizelou 26, Kavala,Greece,65403
Endocrine Private Unit
Country 126371 0
Greece
Phone 126371 0
+302510225200
Fax 126371 0
+302510830900
Email 126371 0
drangelnick@gmail.com
Contact person for scientific queries
Name 126372 0
Dr Nicholaos Angelopoulos, Endocrinologist,MD,Phd
Address 126372 0
Venizelou 26, Kavala,Greece,65403
Private Endocrine Unit
Country 126372 0
Greece
Phone 126372 0
+302510225200
Fax 126372 0
+302510830900
Email 126372 0
drangelnick@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data underlying published results
When will data be available (start and end dates)?
After the publication of the relevant results in a peer-review medical journal and available for 5 years after publication
Available to whom?
researchers who provide a methodologically sound proposal
Available for what types of analyses?
uppon request for sientific purposes ( e.g. meta-analyses)
How or where can data be obtained?
approval by the principal investigator by e-mail: drangelnick@gmail.com


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19043Ethical approval  drangelnick@gmail.com
19044Clinical study report  drangelnick@gmail.com
19045Study protocol  drangelnick@gmail.com
19046Statistical analysis plan  drangelnick@gmail.com



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.