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Three‐arm,placebo‐controlled,randomized clinical trial evaluating the metabolic effect of a combined nutraceutical containing a bergamot standardized flavonoid extract in dyslipidemic overweight subjects
Authors:Arrigo Francesco Giuseppe Cicero  Federica Fogacci  Marilisa Bove  Marina Giovannini  Claudio Borghi
Abstract:Our double‐blind, placebo‐controlled, parallel‐group, dose‐escalation, clinical trial aimed to test the effect of a combined nutraceutical containing bergamot extract (120‐mg flavonoids), phytosterols, vitamin C, and chlorogenic acid from dry artichoke extract on 90 overweight dyslipidemic subjects. Participants were randomly allocated to treatment with two pills of either active treatment or placebo, or a combination of both (a pill per treatment). After 8 weeks, all active‐treated groups experienced a significant improvement in triglycerides (TG) versus placebo and in low‐density lipoprotein cholesterol (LDL‐C) versus baseline and placebo treatments. In the high‐dose‐treated group, also total cholesterol (TC), nonhigh‐density lipoprotein cholesterol (non‐HDL‐C), γ‐glutamil transpeptidasi, high‐sensitivity C‐reactive protein (hs‐CRP), and tumor necrosis factor‐α (TNF‐α) significantly decreased. At 24‐week follow‐up, TG levels maintained lower than baseline in all groups. All patients allocated to either low‐dose or high‐dose active treatment experienced a significant decrease in TG, LDL‐C, and homeostatin model assessment of insulin resistance. In subjects taking high‐dose active treatment, adiponectin significantly increased, whereas TC, non‐HDL‐C, insulin (fasting plasma insulin), leptin, leptin/adiponectin ratio, hs‐CRP, and TNF‐α were significantly reduced. The tested nutraceutical showed to improve lipid and glucose metabolism, adipokines pattern, and systemic inflammation in dyslipidemic overweight subjects.
Keywords:adipokines  bergamot  cholesterol  flavonoids  glucose
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