Un nuovo ipolipidemico. Studio clinico in bambini prepuberi iperlipidemici.

Background Epidemiological studies have shown that oleuro- pein (OL) and hydroxytyrosol (HT), both phenolic compounds in olive oil, possess a significant antioxidant activity, acting as free radical scavengers and inhibiting the oxidation of LDL, in addition to multiple pharmacological activities described in numerous publications in scientific literature. Aim of the study The aim of this study was to test the effect of a new lipid-lo- wering food supplement on an overweight and/or obese pae- diatric population (as indicated by BMI percentiles, according to the Center for Disease Control [CDC]) with hyperlipidemia. Materials and Methods A new hypolipidaemic was used, con- taining 4.5 mg of HT and 10 mg of polyphenols/tablet, admini- stered per os, one tablet / die / 3 months. A group of 20 prepu- bertal patients was enlisted (7 females and 13 males, mean age 8.86 ± 1.47 years) with alteration of at least one of the lipid para- meters (total cholesterol [colTOT] >=180 mg/dL, LDL cholesterol >=110 mg/dL, HDL cholesterol <5°C, triglycerides> 95°C), and characterized by the presence of any possible alteration of the main liver function indexes (transaminases and/or gGT, with or without alteration of ALP, CPK and LDH) and an Index of Fibro- sis (Paediatric NAFLD Fibrosis Index [PNFI], based on triglyce- rides, waist circumference and age, predictive of liver fibrosis if >9). Excluded from the trial were patients with homozygous mu- tation in the MTHFR C677T gene. For three months, from start of treatment, fortnightly anthropometric tests were performed, and laboratory parameter tests were carried out (colTOT, HDL, LDL, triglycerides, ALT, gGT, ALP, CRP, CPK and LDH) at first visit (T0), 45 days (T1), without LDH and CPK, and at 90 days (T2). Conclusions After three months, the lipidaemic profile of many patients seemed to improve, albeit with some dif- ferences, as well as most of the blood chemistry indexes analysed, especially triglycerides and total cholesterol. Re- sults showed that the association of a new hypolipidaemic supplement to a balanced diet for three months led to an improvement in blood chemistry parameters in overweight and/or obese hyperlipidaemic prepubertal patients.