Lipid Metabolism Modulation by a Polyphenol-Standardized <em>Citrus bergamia</em> Extract in an Asian Population: Findings from a Double-Blind, Placebo-Controlled Clinical Trial
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This study aimed to evaluate the efficacy of a polyphenol-standardized (150 mg/day) Citrus bergamia extract in modulating lipid metabolism in an Asian population as the previous two clinicals were conducted on Caucasians utilizing the same dose. To achieve this objective a randomized clinical trial was carried out on 108 subjects with LDL-C levels between 100 and 159 mg/dL, with an evenly divided subgroup specifically comprising those with LDL-C levels ranging from 119 to 139 mg/dL. The intervention period lasted a total of four months, during which participants underwent intermediate assessments at one-month intervals, starting from the second month of supplementation. The primary efficacy endpoints included LDL-C, high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), oxidized LDL (ox-LDL), and paraoxonase-1 (PON1) activity. Secondary endpoints, related to safety evaluation, comprised measurements of body weight, blood pressure, and biochemical parameters indicative of hepatic and renal function. After 4 months, TC and LDL-C levels were significantly reduced by 7.3% and 7.0%, respectively. Moreover, ox-LDL levels showed a significant reduction of 38.5%. No significant changes were observed in secondary safety endpoints. These findings support the efficacy of the polyphenol-standardized Citrus bergamia extract as a natural, safe, and well-tolerated intervention for the modulation of lipid metabolism in an Asian population.