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

INTRODUCTION: Bergamot and opuntia (prickly pear cladodes) standardized extracts have been demonstrated to have positive metabolic effects in preclinical and clinical models. 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 hypercholesterolaemic subjects randomized to take the active compound (2 tablets per day), placebo (2 tablets per day), or both (1 per product per day). RESULTS: 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. CONCLUSIONS: 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.