Metabolic and vascular effect of a new standardized bergamot phytocomplex: a three-arm, placebocontrolled, double-blind clinical trial

Federica Fogacci; Marina Giovannini; Edigio Imbalzano; Elisa Grandi; Elisabetta Rizzoli; Sergio D'Addato; Arrigo F G Cicero

doi:10.5114/aoms/163368

Metabolic and vascular effect of a new standardized bergamot phytocomplex: a three-arm, placebocontrolled, double-blind clinical trial

Arch Med Sci. 2023 May 4;19(5):1228-1235. doi: 10.5114/aoms/163368. eCollection 2023.

Authors

Federica Fogacci^{1

2}, Marina Giovannini^{1

2}, Edigio Imbalzano³, Elisa Grandi¹, Elisabetta Rizzoli¹, Sergio D'Addato¹, Arrigo F G Cicero^{1

2}

Affiliations

¹ Hypertension and cardiovascular risk research center, Medical and Surgical Sciences Department, University of Bologna, Bologna, Italy.
² Italian Nutraceutical Society (SINut), Bologna, Italy.
³ Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.

Abstract

Introduction: In addition to healthy lifestyle and balanced diet, nutraceutical supplementation may be useful to maintain overall metabolic wellness. The aim of the present study was to assess the metabolic and vascular effects of a new, highly standardized bergamot phytocomplex supplement in healthy volunteers with the features of metabolic syndrome.

Material and methods: We carried out a double-blind, randomized, placebo-controlled, three-arm, parallel-group clinical trial in 90 adult subjects (30 per group) treated for 12 weeks with two different dosages of a highly standardized bergamot phytocomplex (Endoberg by AKHYNEX and Kalita by Giellepi) or placebo. Lipid plasma levels, glycemia, plasma hs-CRP, HOMA-IR, body fat, endothelial reactivity and fatty liver index were assessed at baseline, after 6 weeks and at the end of treatment in all subjects.

Results: At the end of treatment, both tested bergamot extract doses were able to significantly improve atherogenic dyslipidemia and insulin sensitivity (p < 0.05) compared to placebo. In the high-dose treated group, total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), non high-density lipoprotein cholesterol (HDL-C), and triglycerides (TG) improved versus placebo (p < 0.05) just after 6 weeks of treatment. After 12 weeks of treatment, TC decreased by 13.2 ±2.1%, LDL-C by 17.7 ±3.2%, non-HDL-C by 17.5 ±3.1%, TG by 16.6 ±3.3%, TG/HDL-C by 22.5 ±4.4%, homeostasis insulin resistance index (HOMA-IR) by 12.2 ±2.1%, γ-glutamyl transferase (GGT) by 22.2 ±4.6%, and high-sensitivity C-reactive protein (hs-CRP) by 17.9 ±3.4% versus baseline (p < 0.05) and vs. placebo (p < 0.05). Percentage body fat and endothelial reactivity improved versus baseline, but not versus placebo, in the high-dose treatment only (p < 0.05).

Conclusions: The tested bergamot phytocomplex was able to significantly improve glucose and lipid metabolism, as well as inflammation, and might represent a novel multi-target approach to control metabolic syndrome.

Keywords: Creactive protein; TG/HDL index; bergamot; metabolic syndrome; randomized clinical trial.