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. 2024 Nov 30;13(23):3883.
doi: 10.3390/foods13233883.

Citrus bergamia Extract, a Natural Approach for Cholesterol and Lipid Metabolism Management: A Randomized, Double-Blind Placebo-Controlled Clinical Trial

Amelia Spina  1 , Fabio Amone  1 , Vincenzo Zaccaria  2 , Violetta Insolia  3 , Anna Perri  4 , Danilo Lofaro  5 , Francesco Puoci  6 , Vincenzo Nobile  7
Affiliations

Citrus bergamia Extract, a Natural Approach for Cholesterol and Lipid Metabolism Management: A Randomized, Double-Blind Placebo-Controlled Clinical Trial

Amelia Spina et al. Foods. .

Abstract

Strategies for controlling cholesterol and lipid metabolism, including the use of food supplements, are part of the non-pharmacological intervention to ameliorate cardiovascular health. To demonstrate the efficacy of a standardized flavonoids (150 mg/day) extract from Citrus bergamia on cholesterol and lipid management, a placebo-controlled clinical trial on 64 subjects with high cholesterol was carried out. The total study duration was 4 months, with intermediate checkpoints at 1-month intervals. Low-density lipoprotein (LDL-C), high-density lipoprotein (HDL-C) cholesterol, total cholesterol (TC) levels, oxidized low-density lipoprotein (ox-LDL), and paraoxonase activity (PON1) were measured as primary endpoints (efficacy evaluation), while weight, blood pressure, hepatic and renal function blood markers were measured as secondary endpoints (safety evaluation). After 4 months, both TC and LDL-C significantly decreased by 8.8% and 11.5%, respectively, along with a 5.5% increase in HDL-C which was trending towards significance. In addition, ox-LDL was significantly reduced by 2.0%, while PON1 was significantly increased by 6.5%. The secondary endpoints were not changed during the study, demonstrating a good tolerability of the test product. Our findings demonstrate the efficacy of the extract as a natural approach for cholesterol and lipid metabolism management.

Keywords: cardiovascular disease; cholesterol; clinical trial; flavonoids; lipid management.

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Conflict of interest statement

V.Z. is a Bionap S.r.l. employee. This does not alter the author’s adherence to all the journal policies on sharing data and materials. The other authors declare no conflicts of interest. The funder had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.

Figures

Figure 1
Figure 1
Participants flow diagram.
Figure 2
Figure 2
Results of the primary endpoints. (a) Low-density lipoprotein cholesterol (LDL-C) levels. (b) High-density lipoprotein (HDL-C) cholesterol levels. (c) Total cholesterol (TC) levels. (d) Oxidized low-density lipoprotein (ox-LDL). (e) Paraoxonase activity (PON1). The intragroup (vs. baseline) statistical analysis is reported within the bars by the symbol *, while the intergroup (active vs. placebo) statistical analysis is reported above the bars by the symbol #, as follows: */# p < 0.05, **/## p < 0.01, ***/### p < 0.001.
See this image and copyright information in PMC

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