None listed
Conditions
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.
Interventions
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 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.
Sponsors
Sarantis Livadas
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Healthy volunteers
No
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/ ).
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
Outcome results
None listed