Effects of a combined nutraceutical on glucose and lipid metabolism in women with post-menopausal incident metabolic syndrome: a double-blind, placebocontrolled, randomized clinical trial

Author Info

Federica Fogacci Alessandro Colletti Arrigo F.G. Cicero Claudio Borghi Maddalena Veronesi Marilisa Bove Marina Giovannini

Corresponding Author

Arrigo F.G. Cicero
Department of Medicine and Surgery Sciences, University of Bologna, Bologna, Italy

A B S T R A C T

Background: Metabolic syndrome is characterized by the impairment of several metabolic and haemodynamic parameters. Several natural compounds have just demonstrated to improve glucose and lipid levels in humans. Aim: To assess the short-term glucose and lipid-lowering effects of a combination of nutraceuticals based on Lagerstroemia speciosa, Berberis aristata, Curcuma longa, alpha-lipoic acid, chrome picolinate and folic acid in patients with post-menopausal incident metabolic syndrome. Methods: We performed a double-blind, placebo-controlled, parallel-group, randomized clinical trial by enrolling 40 women in primary prevention of cardiovascular disease and affected by metabolic syndrome occurred in menopause. After 2-week run-in period of dietary standardization, enrolled patients were allocated to active treatment or placebo for 8 weeks. Data related to lipid pattern, insulin resistance, liver function and hsCRP were obtained at the beginning and at the end of the study. Results: No patient experienced any subjective or laboratory adverse event. During the study, there were no significant changes in waist circumference, body mass index, blood pressure and low-density lipoprotein cholesterol in either treatment groups. Subjects randomized to nutraceutical treatment experienced a significant improvement in triglycerides (TG= -32.2%), high-density lipoprotein cholesterol (HDL-C= +5.7%), fasting plasma insulin (FPI= -14.1%), and in homeostasis model assessment of insulin resistance (HOMA-Index= -27.3%) versus the baseline values, as welle as compared to the placebo-treated group. Conclusions: The tested nutraceutical compound showed to be effective in improving TG, HDL-C, FPI and HOMA-Index, with an optimal tolerability profile in patients with post-menopausal incident metabolic syndrome.

Article Info

Article Type

Research Article

Publication history

Received: Mon 22, Apr 2019
Accepted: Thu 09, May 2019
Published: Tue 11, Jun 2019

Copyright

© 2023 Arrigo F.G. Cicero. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Hosting by Science Repository.
DOI: 10.31487/j.JFNM.2019.02.01