Aim: 

We assessed the effects of genistein aglycone on some cardiovascular risk factors after 3 years of continued therapy in a cohort of postmenopausal women.

Methods: 

The parent study was a randomized, double-blind, placebo-controlled trial involving 389 osteopenic, postmenopausal women for 24-months. Subsequently, a subcohort (138 patients) continued therapy for an additional year. Participants received 54 mg of genistein aglycone (n=71) or placebo (n=67), daily. Both arms received calcium and vitamin D3 in therapeutic doses. Moreover, all patients received dietary instructions in an isocaloric fat-restricted diet. Blood lipid profiles, fasting glucose and insulin, HOMA-IR, fibrinogen, osteoprotegerin (OPG) and homocysteine at baseline and after 24 and 36 months of treatment were measured.

Results: 

Compared to placebo, genistein significantly decreased fasting glucose and insulin, HOMA-IR, fibrinogen and homocysteine after 24 and 36 months of treatment. By contrast, isoflavone administration did not affect HDL cholesterol and triglycerides though serum OPG was higher in the genistein recipients. There were no differences in adverse events between groups. Results on routine biochemical, liver function, and hematologic testing did not change over time in placebo or genistein group.

Conclusions: 

After 3-years of treatment, genistein aglycone plus calcium, vitamin D3 and a healthy diet showed positive effects on some cardiovascular risk factors in a cohort of postmenopausal women.