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Trial registered on ANZCTR


Registration number
ACTRN12623000621617
Ethics application status
Approved
Date submitted
25/04/2023
Date registered
7/06/2023
Date last updated
7/06/2023
Date data sharing statement initially provided
7/06/2023
Date results information initially provided
7/06/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigating the effect of low dose monacolin K combined with coenzyme Q10, Grape Seed, and Olive Leaf Extracts on low density lipoprotein (LDL) cholesterol in patients with mild dyslipidemia
Scientific title
Investigating the effect of low dose monacolin K combined with coenzyme Q10, Grape Seed, and Olive Leaf Extracts on LDL cholesterol in patients with mild dyslipidemia
Secondary ID [1] 309341 0
None
Universal Trial Number (UTN)
Trial acronym
MKNQ10
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mild dyslipidemia 329545 0
Condition category
Condition code
Metabolic and Endocrine 326477 326477 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Administration of a commercially available dietary supplement, containing of monacolin ( low dose group: 3mg and high dose group 10mg) combined with fix doses of: coenzyme Q10 (CoQ10) 2mg, olive leaf extract (OLE) 50mg, Grape seed extract 50mg (GSE), and vitamin B complex ( Biotin 50mcg, B12 2mcg, Vitamin B5 6 mg,Vitamin B6 1.4 mg, Vitamin B2 1.4 mg, Vitamin B1 1.1 mg and Folic acid 200mcg) in volunteers with moderate elevations in LDL-C concentrations and low cardiovascular risk
Duration of administration: One oral tablet daily every evening after food,for 8 weeks
Adherence monitoring: tablet return.
Intervention code [1] 325778 0
Treatment: Other
Comparator / control treatment
Control group: Patients with mild hyperlipidemia and No medical or supplement treatment
Control group
Active

Outcomes
Primary outcome [1] 334318 0
Changes in Lipid levels: Total Cholesterol (TC), triglycerides (TG), Low-density lipoprotein (LDL), High density lipoprotein (LDL) will be determined by a blood test
Timepoint [1] 334318 0
2 months post - intervention commencement
Secondary outcome [1] 420240 0
Changes in liver function: alanine transaminase (ALT) , aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT) and creatine phosphokinase (CPK) will be determined by a blood test
Timepoint [1] 420240 0
2 months post - intervention commencement

Eligibility
Key inclusion criteria
Patients were eligible to participate in the present study if they were greater or equal to 40 years of age, had 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 was 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
70 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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation table created by computer software (computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Normality of the distribution of our data was analyzed using the Kolmogorov– Smirnov test. Differences of data with skewed distributions were analyzed with the Wilcoxon non-parametric test. The Kruskal-Wallis test was used to examine significant differences between groups with respect to dependent variables. A Dunn-Bonferroni test was then used to compare the groups in pairs, to investigate which was significantly different. Results were presented as mean values± standard deviation (SD). Moreover, the difference between time points was indicated in percentage. Statistical Package of Social Sciences 21.0 (SPSS Inc., Chicago, IL, USA) was used for the statistical analysis and p values < 0.05 were deemed significant.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
1/03/2023
Date of last participant enrolment
Anticipated
Actual
1/05/2023
Date of last data collection
Anticipated
1/08/2023
Actual
Sample size
Target
110
Accrual to date
Final
105
Recruitment outside Australia
Country [1] 25362 0
Greece
State/province [1] 25362 0
Attiki

Funding & Sponsors
Funding source category [1] 313547 0
Self funded/Unfunded
Name [1] 313547 0
Sarantis Livadas
Country [1] 313547 0
Greece
Primary sponsor type
Individual
Name
Sarantis Livadas
Address
Private Endocrine Clinic, Ermou 6, 10563, ATHENS,Greece
Country
Greece
Secondary sponsor category [1] 315325 0
None
Name [1] 315325 0
NONE
Address [1] 315325 0
NONE
Country [1] 315325 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312724 0
Institutional Review Board of the Athens Medical Center General Hospital, Athens, Greece
Ethics committee address [1] 312724 0
Distomou 5-7, Marousi 151 25, ATHENS
Ethics committee country [1] 312724 0
Greece
Date submitted for ethics approval [1] 312724 0
15/11/2022
Approval date [1] 312724 0
08/12/2022
Ethics approval number [1] 312724 0
01122022/100

Summary
Brief summary
To assess the lipid-lowering activity and safety of a novel, commercially available dietary supplement, containing low dose of monacolin (3mg) combined with CoQ10, OLE), GSE, and vitamin B complex in volunteers with moderate elevations in LDL-C concentrations and low cardiovascular risk.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125678 0
Dr Sarantis Livadas
Address 125678 0
Endocrine private Clinic, ERMOU 6, 10563, ATHENS, Athens , Greece
Country 125678 0
Greece
Phone 125678 0
+302103250745
Fax 125678 0
Email 125678 0
[email protected]
Contact person for public queries
Name 125679 0
Sarantis Livadas
Address 125679 0
Endocrine private Clinic, ERMOU 6, 10563, ATHENS, Athens , Greece
Country 125679 0
Greece
Phone 125679 0
+302103250745
Fax 125679 0
Email 125679 0
[email protected]
Contact person for scientific queries
Name 125680 0
Sarantis Livadas
Address 125680 0
Endocrine private Clinic, ERMOU 6, 10563, ATHENS, Athens , Greece
Country 125680 0
Greece
Phone 125680 0
+302103250745
Fax 125680 0
Email 125680 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseLow Dose Monacolin K Combined with Coenzyme Q10, Grape Seed, and Olive Leaf Extracts Lowers LDL Cholesterol in Patients with Mild Dyslipidemia: A Multicenter, Randomized Controlled Trial.2023https://dx.doi.org/10.3390/nu15122682
N.B. These documents automatically identified may not have been verified by the study sponsor.