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.

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.

Validation of three professional devices measuring office blood pressure according to three different methods: the Omron BP10, the Omron HBP T105 and the Pic Indolor Professional.

OBJECTIVE: Three professional devices for office blood pressure (BP) measurement, using three different algorithms to determine BP, were evaluated according to the International Protocol of the European Society of Hypertension. The Omron BP10 uses the oscillometric method, the Omron HBP T105 (module HBP-M3600) uses the smart inflation mode and high-speed measurement and the Pic Indolor Professional check is a hybrid sphygmomanometer. METHODS: The International Protocol of the European Society of Hypertension is divided into two phases and includes a total number of 33 participants on whom the validation is performed. In each study and for each participant, four BP measurements were performed simultaneously by two observers using mercury sphygmomanometers alternately with three measurements by the tested device. The difference between the observers and the device BP values was calculated for each measure. The 99 pairs BP differences were classified into three categories (

Validation of four automatic devices for self-measurement of blood pressure according to the International Protocol: the Pic Indolor Personal Check, Comfort Check, My Check and Travel Check.

OBJECTIVE: Four oscillometric devices for self-measurement of blood pressure (SBPM) were evaluated according to the International Protocol of the European Society of Hypertension (ESH) in four separate studies. The Pic Indolor Personal Check, Comfort Check and My Check measure blood pressure (BP) at the brachial level; the Travel Check measures radial BP at the wrist level. METHODS: The International Protocol includes a total number of 33 subjects. In each study and for each subject, four BP measurements were performed simultaneously by two observers using mercury sphygmomanometers alternately with three measurements by the tested device. The difference between the observers and the device BP values (99 pairs) were classified into three categories (< or =5, < or =10, < or =15 mmHg). RESULTS: All four tested devices passed the validation process. The mean differences between the device and mercury readings were 0.1 +/- 2.9 and -0.1 +/- 3.8 mmHg for systolic and diastolic BP respectively for the Personal Check; -1.0 +/- 3.7 and 0.2 +/- 3.2 mmHg for the Comfort Check; -0.6 +/- 4.5 and -1.5 +/- 4.3 mmHg for the My Check; -0.1 +/- 2.0 and 0.6 +/- 1.7 mmHg for the Travel Check. CONCLUSION: Readings of the Pic Indolor Personal Check, Comfort Check, My Check and Travel Check devices differing by less than 5, 10 and 15 mmHg fulfill the International Protocol requirements and therefore can be used by patients for SBPM.