BACKGROUND AND AIM: Recent evidence suggests that genistein aglycone may act beneficially on surrogate cardiovascular risk markers in postmenopausal women. We assessed the effects of genistein aglycone on some cardiovascular risk factors and homocysteine levels after 3-years of continued therapy in a cohort of osteopenic, postmenopausal women. METHODS AND RESULTS: The parent study was a randomized, double-blind, placebo-controlled trial involving 389 postmenopausal women with low bone mass for 24 months. Subsequently, a subcohort (138 patients) continued therapy for an additional year. Participants received 54mg of genistein aglycone (n=71) or placebo (n=67), daily. Both arms received calcium and vitamin D(3) in therapeutic doses. Moreover, 4 weeks before randomization procedures and during our follow-up study, all patients received dietary instructions in an isocaloric fat-restricted diet. Blood lipid profiles, fasting glucose and insulin, insulin resistance (HOMA-IR), fibrinogen, osteoprotegerin (OPG) and homocysteine at baseline and after 24 and 36 months of treatment were measured. 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 high-density lipoprotein cholesterol and triglycerides though serum OPG was higher in the genistein recipients. There were no differences in adverse events or discomfort 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 D(3) and a healthy diet showed positive effects on some cardiovascular risk factors and homocysteine levels in a cohort of postmenopausal women with low bone mass.
RCT Entities:
BACKGROUND AND AIM: Recent evidence suggests that genistein aglycone may act beneficially on surrogate cardiovascular risk markers in postmenopausal women. We assessed the effects of genistein aglycone on some cardiovascular risk factors and homocysteine levels after 3-years of continued therapy in a cohort of osteopenic, postmenopausal women. METHODS AND RESULTS: The parent study was a randomized, double-blind, placebo-controlled trial involving 389 postmenopausal women with low bone mass for 24 months. Subsequently, a subcohort (138 patients) continued therapy for an additional year. Participants received 54mg of genistein aglycone (n=71) or placebo (n=67), daily. Both arms received calcium and vitamin D(3) in therapeutic doses. Moreover, 4 weeks before randomization procedures and during our follow-up study, all patients received dietary instructions in an isocaloric fat-restricted diet. Blood lipid profiles, fasting glucose and insulin, insulin resistance (HOMA-IR), fibrinogen, osteoprotegerin (OPG) and homocysteine at baseline and after 24 and 36 months of treatment were measured. 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 high-density lipoprotein cholesterol and triglycerides though serum OPG was higher in the genistein recipients. There were no differences in adverse events or discomfort 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 D(3) and a healthy diet showed positive effects on some cardiovascular risk factors and homocysteine levels in a cohort of postmenopausal women with low bone mass.
Authors: M Atteritano; S Mazzaferro; A Bitto; M L Cannata; R D'Anna; F Squadrito; I Macrì; A Frisina; N Frisina; G Bagnato Journal: Osteoporos Int Date: 2013-10-10 Impact factor: 4.507
Authors: H Marini; F Polito; D Altavilla; N Irrera; L Minutoli; M Calò; E B Adamo; M Vaccaro; F Squadrito; A Bitto Journal: Br J Pharmacol Date: 2010-07 Impact factor: 8.739
Authors: Javad Sharifi-Rad; Cristina Quispe; Muhammad Imran; Abdur Rauf; Muhammad Nadeem; Tanweer Aslam Gondal; Bashir Ahmad; Muhammad Atif; Mohammad S Mubarak; Oksana Sytar; Oxana Mihailovna Zhilina; Ekaterina Robertovna Garsiya; Antonella Smeriglio; Domenico Trombetta; Daniel Gabriel Pons; Miquel Martorell; Susana M Cardoso; Ahmad Faizal Abdull Razis; Usman Sunusi; Ramla Muhammad Kamal; Lia Sanda Rotariu; Monica Butnariu; Anca Oana Docea; Daniela Calina Journal: Oxid Med Cell Longev Date: 2021-07-19 Impact factor: 6.543
Authors: Herbert Marini; Francesca Polito; Elena B Adamo; Alessandra Bitto; Francesco Squadrito; Salvatore Benvenga Journal: Front Endocrinol (Lausanne) Date: 2012-07-31 Impact factor: 5.555