Comparative effect of a nutraceutical compound based on a flavonoid complex from bergamot on plasma lipids, glucose metabolism, and liver enzymes: a 3-arm, double-blind, placebo-controlled, randomized clinical trial.

Abstract

Bergamot and opuntia (prickly pear cladodes) standardized extracts have been demonstrated to have positive metabolic effects in preclinical and clinical models. 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 hypercholesterolaemic subjects randomized to take the active compound (2 tablets per day), placebo (2 tablets per day), or both (1 per product per day). After 12 weeks of treatment with 1 tablet per day, we observed a significant reduction of a number of metabolic parameters: total cholesterol (TC) (-14.6%), low-density lipoprotein cholesterol (LDL-C) (-19.9%), 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 γ-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 to 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, fasting plasma glucose, and liver enzyme in overall healthy subjects affected by hypercholesterolaemia with low cardiovascular risk.