ISSN: 2451-0629
Archives of Medical Science - Atherosclerotic Diseases
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Official journal of the International Lipid Expert Panel (ILEP)
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1/2020
vol. 5
 
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abstract:
Clinical research

A double-blind, placebo-controlled clinical trial to assess the effects of a combined nutraceutical on endothelial function in patients with mild-to-moderate hypercholesterolaemia

Valerio Pecchioli
1
,
Arrigo F.G. Cicero
2
,
Nazareno Lomartire
3
,
Maria P. Gemmiti
4
,
Antonello Colangeli
5
,
Rosanna Germanò
6
,
Maria Pia Corsi
4
,
Giuseppe I.W. Germanò
6

1.
Cardiovascular Prevention Unit, Hospital Department ASL Frosinone, Italy
2.
Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Italy
3.
Anaesthesiology and Intensive Care Unit, ASL, Frosinone, Italy
4.
Cardiology and Cardiological Intensive Care Unit, ASL Frosinone, Italy
5.
Pneumology Unit, Department of Internal Medicine, University of L’Aquila, Italy
6.
Policlinico Umberto I University “La Sapienza”, Rome, Italy
Arch Med Sci Atheroscler Dis 2020; 5: e36–e42
Online publish date: 2020/05/07
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Introduction
There is growing interest in lipid-lowering nutraceuticals; however, there are a relative scarcity of data on combined compounds. This study was aimed to assess the efficacy and tolerability of a combined nutraceutical (CARDIOL® Forte – CF) containing polyunsaturated fatty acids, hydroxytyrosol, Coenzyme Q10, folic acid, B12 and E vitamins, piperine, and red yeast rice in patients with mild-to-moderate hypercholesterolaemia.

Material and methods
In this single-centre, double-blinded, placebo-controlled study enrolled subjects who were randomised to receive the tested combined nutraceutical for 16 weeks (CF group) or placebo (control group), in association with a low-fat diet. After 8 weeks of treatment, all patients underwent a 15-day washout period; then, a further 8 weeks of treatment was planned.

Results
Of 80 enrolled subjects, 37 completed the study in the CF group and 38 in the control group. After 8 weeks of treatment, low-density lipoprotein cholesterol levels were reduced by 17% in the CF group and by 6.4% in the control group, compared to baseline (p = 0.0001); these changes were improved at the end of study. Total cholesterol and triglyceride levels significantly decreased during treatment; high-density lipoprotein cholesterol did not change. In the CF group, flow-mediated dilation increased by 18.8% after 8 weeks and by 39.3% at the end of treatment. No adverse events or musculoskeletal disorders were reported in either group.

Conclusions
The tested combined nutraceutical, in association with a controlled diet, can reduce cholesterol levels and improve endothelial function, thus reducing the cardiovascular risk in patients with mild-to-moderate hypercholesterolaemia.

keywords:

nutraceutical, hypercholesterolaemia, red yeast rice, monacolin K, low-density lipoprotein-cholesterol, endothelial function

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