Bergamot and opuntia (prickly pear cladodes) standardized extracts have demonstrated to have positive metabolic effects in preclinical and clinical model.

Material and methods:
The aim of this study was to evaluate the metabolic effect of a combined nutraceutical containing 150 mg of Opuntia ficus Indica extract, 400 mg of Plant sterols, 12.5 mg of Thiamine and 200 mg of Brumex®, a phytocomplex from bergamot fruit (Citrus bergamia Risso et Poiteau, fructus) standardized 40% in total flavonoids and min 5% in 3-hydroxy-3-methylglutaryl-flavanones. Thus, we carried out a randomized, double-blind, placebo-controlled clinical trial on 75 hypercholesterolemic subjects randomized to take the active compound (2 tablets per day), placebo (2 tablets/day), both (1 per product/day).

After 12 weeks of treatment with 1 tablet per day, we observed a significant reduction of a number of metabolic parameters: Total (TC)= -14.6%, low‐density lipoprotein (LDL‐C)= -19.9%, and non high-density lipoprotein cholesterol (non‐HDLC)= -22.1%, triglycerides (TG)= -13.1%, Apolipoprotein B= -16% (all p<0.05 both versus baseline and versus placebo), fasting plasma glucose= -5.1%, glutamate oxaloacetate transaminase= -7.8%, glutamate pyruvate transaminase= -7.3% and gamma-glutamyl transferase= -34.4% (all p<0.05 versus baseline). High‐density lipoprotein cholesterol (HDL-C) was increased 6.9% by the use of 1 tablet per day (p<0.05 versus baseline). All parameters were reduced at the same extent when taking the full dose (2 tablets), beyond TG.

The tested nutraceutical compound based on a flavonoid complex from bergamot and opuntia showed a short-term positive impact on plasma lipids, plasma glucose and liver enzyme in overall healthy subjects affected by hypercholesterolemia with low cardiovascular risk.