Purpose Polyphenols are an important category of natural compounds able to modulate inflammatory pathways.
Our double-blind, placebo-controlled, parallel-group clinical trial aimed to test the effect of a combined nutraceutical containing bergamot extract (120 mg flavonoids), 120 mg phytosterols, 20 mg vitamin C and 2 mg chlorogenic acid from dry artichoke extract on 90 overweight subjects with dyslipidemia.
Methods Participants were randomly allocated to treatment with two pills of either active treatment or placebo, or a combination of both (a pill per treatment).
Results At 8-week visit, all groups significantly differed for TG, with lower levels in the high-dose group in comparison with placebo (p<0.05). All patients randomized to receive either low-dose or high-dose active treatment experienced a significant decrease in LDL-C versus both baseline and placebo treatment. Furthermore, in the high-dose group, a significant reduction was found between the baseline and follow-up levels of TC, non HDL-C, Gamma-GT, hs-CRP and TNF-apha. TC levels significantly decreased also in comparison with placebo (p<0.05 always). At 24-week follow-up, TG levels maintained lower than baseline in all groups (p<0.05). All patients allocated to either low-dose or high-dose active treatment experienced a significant decrease in TG, LDL-C and HOMA-IR versus baseline and placebo. Furthermore, in subjects taking high-dose active treatment adiponectin significantly increased while TC, non HDL-C, FPI, leptin, leptin/adiponectin ratio, hs-CRP and TNF-apha were significantly reduced as compared with placebo and baseline (p<0.05 always).
Conclusion In conclusion, the tested nutraceutical showed to improve lipid and glucose metabolism, adipokines pattern and systemic inflammation in dyslipidemic overweight subjects.

03 - THREE-ARM, PLACEBO CONTROLLED, RANDOMIZED CLINICAL TRIAL EVALUATING THE METABOLIC EFFECT OF A BERGAMOT STANDARDIZED FLAVONOID EXTRACT IN DYSLIPIDEMIC OVERWEIGHT SUBJECTS.