Abstract
BackgroundHypercholesterolemia is a major risk factor for cardiovascular disorders and requires specific intervention through an adequate lifestyle (diet and physical exercise) and, if necessary, an appropriate drug treatment. Lipid-lowering drugs, although generally efficacious, may sometimes cause adverse events. A growing attention has been devoted to the correction of dyslipidemias through the use of dietary supplements. The aim of this study was to assess the lipid-lowering activity and safety of a dietary supplement containing monacolin K, L-arginine, coenzyme Q10 and ascorbic acid, named Argicolina (A), compared to a commercially available product containing monacolin K and coenzyme Q10, Normolip 5 (N).MethodsThis was a single center, controlled, randomized, open-label, cross-over clinical study enrolling 20 Caucasian outpatients aged 18–75 years with serum LDL-C between 130 and 180 mg/dL. Patients assumed two different dietary supplements (A and N) both containing monacolin K 10 mg for 8 weeks each, separated by a 4-week wash-out period. Evaluated parameters were: Total cholesterol (Tot-C), low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), triglycerides (TG), fasting blood glucose, aspartate aminotransferase, alanine aminotransferase, creatinekinase, gamma-glutamyl-transpeptidase, brachial arterial pressure and heart rate, measured at the start and at the end of each treatment period. Safety was monitored through the study.ResultsLDL-C decreased by 23.3% during treatment with N (p < 0.0001) and by 25.6% during treatment with A (p < 0.0001); the LDL-C mean reduction was 36.4 (95% CI: 45,6–27,1) mg/dL during N treatment and 40.1 (95% CI: 49.2–30,9) mg/dL during A treatment. Tot-C decreased significantly (p < 0.0001) within each treatment period. HDL-C increase was negligible during A whereas it was significant during N. TG diminished markedly during A and not significantly during N. The difference between treatments was not statistically significant for all variables. No serious or severe adverse events occurred during the study.ConclusionsOur results confirm the clinically meaningful LDL-C lowering properties of monacolin K. At variance with a supplement already in the market (N), the novel association (A) of monacolin K with L-arginine, coenzime Q10 and ascorbic acid also produces a significant reduction of triglycerides without significant effects on HDL.Trial registrationClinicalTrials.gov ID: NCT03425630.
Highlights
Hypercholesterolemia is a major risk factor for cardiovascular disorders and requires specific intervention through an adequate lifestyle and, if necessary, an appropriate drug treatment
Over the past few years a growing attention has been devoted to the correction of dyslipidemias through the use of dietary supplements, either because some patients may have milder forms of hypercholesterolemia or as an alternative to statins in patients who may have experienced side effects, the potential adverse effects caused by supplements have not been fully investigated
In this work we have investigated the lipid lowering capacities of a novel association containing monacolin K, L-arginine, coenzyme Q10 and ascorbic acid
Summary
Hypercholesterolemia is a major risk factor for cardiovascular disorders and requires specific intervention through an adequate lifestyle (diet and physical exercise) and, if necessary, an appropriate drug treatment. Studies have shown a reduction in serum total cholesterol (Tot-C) between 12 and 30% after the administration of products containing from 3 to 10 mg of monacolin K, for treatments ranging from 4 weeks up to 1 year [11, 13,14,15] Some of these trials have reported a lower incidence of myopathies compared to statins [16]. The aim of this study was to assess the lipid-lowering activity and safety of the proposed formulation in patients with mild-moderate hypercholesterolemia, compared to a commercially available dietary supplement containing monacolin K and coenzyme Q10 (Normolip 5: N) (ESI - Albissola Marina, Savona, Italy). The study was conducted according to a randomized cross-over design
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.