Combined nutraceutical approach to postmenopausal syndrome and vascular remodeling biomarkers.

Objective: Menopause is associated with broad, though generally not massive changes in a large number of metabolic parameters. The aim of our study was to evaluate the efficacy and tolerability of a combined nutraceutical approach on a large number of cardiometabolic risk markers and menopause symptoms in otherwise healthy, mildly dyslipidemic postmenopausal women. Design/setting: Forty women were enrolled in the context of a controlled, randomized, prospective study with parallel groups at the Lipid Clinic of the University of Bologna. Intervention: The women were randomized to treatment with a nutraceuticals containing soy isoflavones (60 mg) and berberine (500 mg) or a placebo at a dosage of one tablet daily between meals for 12 weeks. Results: All patients completed the study without significant side effects. Anthropometric measures, blood pressure, HOMA index, and basal homocysteinemia significantly improved in isoflavones-berberine-treated group when compared to the baseline, but not when compared to the placebo-treated patients. Compared to placebo-treated patients, those treated with isoflavones-berberine experienced a significant improvement in plasma lipid and metalloproteinase serum levels, as well as the main menopausal symptoms. Conclusion: The short-term consumption of a nutraceutical containing isoflavones and berberine was well-tolerated and improved menopausal symptoms, plasma lipid level, and serum levels of matrix metalloproteinases in a cohort of mildly dyslipidemic postmenopausal women when compared with a neutral control.