ANZCTR - Registration

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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 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]

Nil known

Universal Trial Number (UTN)

U1111-1292-0069

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

hyperlipidemia

cardiovascular disease

Condition category

Condition code

Cardiovascular

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]

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]

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]

Baseline, and 12 weeks after intervention commencement.

Secondary outcome [1]

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]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Greece

State/province [1]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Nicholaos Angelopoulos

Address [1]

Venizelou 26, Kavala,Greece,65403

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Athens Medical Centre General Hospital,Athens,Greece

Ethics committee address [1]

distomou 5-7, Athens, Greece, 15125

Ethics committee country [1]

Greece

Date submitted for ethics approval [1]

01/12/2022

Approval date [1]

12/12/2022

Ethics approval number [1]

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

Dr Nicholaos Angelopoulos, Endocrinologist,MD,Phd

Address

Venizelou 26, Kavala,Greece,65403
Private Endocrine Unit

Country

Greece

Phone

+302510225200

Fax

+302510830900

[email protected]

Contact person for public queries

Name

Nicholaos Angelopoulos, Endocrinologist,MD,Phd

Address

Venizelou 26, Kavala,Greece,65403
Endocrine Private Unit

Country

Greece

Phone

+302510225200

Fax

+302510830900

[email protected]

Contact person for scientific queries

Name

Nicholaos Angelopoulos, Endocrinologist,MD,Phd

Address

Venizelou 26, Kavala,Greece,65403
Private Endocrine Unit

Country

Greece

Phone

+302510225200

Fax

+302510830900

[email protected]

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: [email protected]

What supporting documents are/will be available?

Doc. No.	Type	Email
19043	Ethical approval	[email protected]
19044	Clinical study report	[email protected]
19045	Study protocol	[email protected]
19046	Statistical analysis plan	[email protected]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically