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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
Author(s) -
Cicero Arrigo Francesco Giuseppe,
Fogacci Federica,
Bove Marilisa,
Giovannini Marina,
Borghi Claudio
Publication year - 2019
Publication title -
phytotherapy research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.019
H-Index - 129
eISSN - 1099-1573
pISSN - 0951-418X
DOI - 10.1002/ptr.6402
Subject(s) - adiponectin , medicine , placebo , insulin resistance , endocrinology , overweight , adipokine , insulin , obesity , alternative medicine , pathology
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.