LDL-cholesterol lowering effect of a new dietary supplement: an open label, controlled, randomized, cross-over clinical trial in patients with mild-to-moderate hypercholesterolemia

S Magno, G Ceccarini, C Pelosini, R Jaccheri, J Vitti, P Fierabracci, G Salvetti, G Airoldi, M Minale, G Saponati, F Santini, S Magno, G Ceccarini, C Pelosini, R Jaccheri, J Vitti, P Fierabracci, G Salvetti, G Airoldi, M Minale, G Saponati, F Santini

Abstract

Background: 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. 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).

Methods: This 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.

Results: LDL-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.

Conclusions: Our 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 registration: ClinicalTrials.gov ID: NCT03425630 .

Keywords: Hypercholesterolemia; LDL-cholesterol (LDL-C); Monacolin K; Red reast rice; Triglycerides.

Conflict of interest statement

Ethics approval and consent to participate

The study protocol, the patient information sheet, the informed consent form, the letter to general practitioner and the “privacy statement” sheet were examined and approved by the reference Ethic Committee of the investigational study site (Italian National Health Institute. Comitato Etico Area Vasta Nord Ovest [CEAVNO] Toscana, Pisa, Italy) prior to any study-related procedure was started. The study initiation was notified to the Italian Ministry of Health. The study was conducted according to the principles defined in the Declaration of Helsinki and amendments, and to the procedures of Good Clinical Practice (whenever applicable), expressed in the guideline set out by the International Conference on Harmonization. The decision on study participation was freely and in written taken by the patient, and it was clarified that the consent could have been withdrawn at any time, without penalty or loss of patient’ rights of benefits.

Competing interests

The authors declare that they have no competing interests.

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Figures

Fig. 1
Fig. 1
Study flow-chart
Fig. 2
Fig. 2
LDL-C values (mean and SD) through the study, split by treatment sequence
Fig. 3
Fig. 3
Individual values of LDL cholesterol (LDL-C, mg/dL) before and after Argicolina (A) and Normolip (N) treatment
Fig. 4
Fig. 4
Percent changes during A and N treatments of total cholesterol, HDL-cholesterol LDL-cholesterol and triglycerides (TG). Data are expressed as (final-initial) / initial values

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