Efficacy of a nutraceutical combination on lipid metabolism in patients with metabolic syndrome: a multicenter, double blind, randomized, placebo controlled trial

Randomized Controlled Trial

doi: 10.1186/s12944-019-1002-y.

Valeria Fazio [ 2](#full-view-affiliation-2 "Department of Clinical Medicine and Surgery, ESH Excellence Centre of Hypertension, "Federico II" University of Naples Medical School, Naples, Italy."), Marco Gentile [ 2](#full-view-affiliation-2 "Department of Clinical Medicine and Surgery, ESH Excellence Centre of Hypertension, "Federico II" University of Naples Medical School, Naples, Italy."), Giuseppe Schillaci 3, Giacomo Pucci 3, Francesca Battista 3, Valentina Mercurio [ 4](#full-view-affiliation-4 "Department of Translational Medical Sciences, "Federico II" University of Naples Medical School, Naples, Italy."), Giorgio Bosso [ 4](#full-view-affiliation-4 "Department of Translational Medical Sciences, "Federico II" University of Naples Medical School, Naples, Italy."), Domenico Bonaduce [ 4](#full-view-affiliation-4 "Department of Translational Medical Sciences, "Federico II" University of Naples Medical School, Naples, Italy."), Nadia Brambilla 5, Cristina Vitalini 5, Massimo D'Amato 5, Giampaolo Giacovelli 5

Affiliations

PMID: 30885221
PMCID: PMC6421674
DOI: 10.1186/s12944-019-1002-y

Randomized Controlled Trial

Ferruccio Galletti et al. Lipids Health Dis. 2019.

Abstract

Background: Nutraceuticals represent a new therapeutic frontier in the treatment of metabolic syndrom (MetS) and related cardiovascular risk factors. The aim of this study was to evaluate the potential beneficial effects of Armolipid Plus (AP) (berberine 500 mg, red yest rice, monacolin K 3 mg and policosanol 10 mg) on insulin resistance, lipid profile, particularly on small and dense LDL cholesterol (sdLDL-C), representing the most atherogenic components, as well as its effects on high sensitivity C-reactive protein, a notable marker of cardiovascular risk, blood pressure and cardiac remodeling in subjects affected by MetS, with left ventricular hypertrophy.

Methods: The study was a prospective, multi-center, randomized, double blind, placebo-controlled trial. One hundred and fifty eight patients, aged between 28 and 76 years old, were enrolled and randomized to receive either one tablet of AP or placebo (PL) once daily for 24 weeks. Anthropometric and vital parameters, total cholesterol (tot-C), low-density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), triglyceridemia (TG), non-HDL cholesterol (NHDL-C) and sdLDL-C were evaluated.

Results: After 24 weeks of treatment, the analysis performed on 141 subjects (71 in AP arm and 70 in PL arm), showed a significant improvement of lipid profile in the AP group, with reduction in tot-C (- 13.2 mg/dl), LDL-C (- 13.9 mg/dl) and NHDL-C (- 15.3 mg/dl) and increase in HDL-C (+ 2.0 mg/dl). These changes were equally significant compared with placebo (tot-C: AP - 13.2 mg/dL vs PL + 2.7 mg/dL, p < 0.01; LDL-C: AP -13.9 mg/dl vs PL + 1.5 mg/dl, p < 0.01; NHDL-C: AP -15.3 mg/dl vs PL + 2.8 mg/dl, p < 0.01), Although no significant difference was observed between the two arms in the reduction of HDL-C nevertheless it increased significantly in the AP group (AP + 2 mg/dL p < 0.05, PL 0.13 mg/dL).

Conclusion: The results of this study, applicable to a specific local population show that, in a population of subjects affected by MetS, treatment with AP improves the lipid profile and the most atherogenic factors, thus suggesting a reduction in the risk of development and progression of atherosclerosis, particularly in subjects with high atherogenic risk, due to the presence of sdLDL-C.

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Conflict of interest statement

The Institutional Ethics Committee of each site approved the study protocol before initiating any trial related activity, and written informed consent was obtained from each patient. The study was conducted in accordance with the principles of the Declaration of Helsinki.

None of the authors has financial relations (personal and institutional) that might be a potential conflict of interest.

All co-authors have read and approved the submission of this manuscript; the content of the manuscript has not been published and is not being considered for publication elsewhere.

Competing interest

The study was sponsored by Rottapharm SpA, Monza Italy.

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Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1

Study flow diagram

Fig. 2

Changes in sdLDL-C size at wk. 24. * = p < 0.05 24 wks vs Baseline

Fig. 3

CRP-Hs levels after 24 weeks of treatment. formula image = AP, = PL Treatment. * = p < 0.05 24 wks vs Baseline

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Efficacy of a nutraceutical combination on lipid metabolism in patients with metabolic syndrome: a multicenter, double blind, randomized, placebo controlled trial - PubMed (original) (raw)