title: Efficacy of genistein aglycone on some cardiovascular risk factors and homocysteine levels: A follow-up study.
abstract: OBJECTIVE
  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.
  
  
  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.affiliation: Department of Biochemical, Physiological and Nutritional Sciences, Section of Physiology and Human Nutrition, University of Messina, Italy.
authors.forename: H
authors.initials: H
authors.lastname: Marini
authors.forename: A
authors.initials: A
authors.lastname: Bitto
authors.forename: D
authors.initials: D
authors.lastname: Altavilla
authors.forename: B P
authors.initials: BP
authors.lastname: Burnett
authors.forename: F
authors.initials: F
authors.lastname: Polito
authors.forename: V
authors.initials: V
authors.lastname: Di Stefano
authors.forename: L
authors.initials: L
authors.lastname: Minutoli
authors.forename: M
authors.initials: M
authors.lastname: Atteritano
authors.forename: R M
authors.initials: RM
authors.lastname: Levy
authors.forename: N
authors.initials: N
authors.lastname: Frisina
authors.forename: S
authors.initials: S
authors.lastname: Mazzaferro
authors.forename: A
authors.initials: A
authors.lastname: Frisina
authors.forename: R
authors.initials: R
authors.lastname: D'Anna
authors.forename: F
authors.initials: F
authors.lastname: Cancellieri
authors.forename: M L
authors.initials: ML
authors.lastname: Cannata
authors.forename: F
authors.initials: F
authors.lastname: Corrado
authors.forename: C
authors.initials: C
authors.lastname: Lubrano
authors.forename: R
authors.initials: R
authors.lastname: Marini
authors.forename: E B
authors.initials: EB
authors.lastname: Adamo
authors.forename: F
authors.initials: F
authors.lastname: Squadrito
mesh_terms: D002119:Calcium Carbonate / Q000008:administration & dosage; D002318:Cardiovascular Diseases / Q000517:prevention & control*; D002762:Cholecalciferol / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D019833:Genistein / Q000009:adverse effects / Q000494:pharmacology*; D006710:Homocysteine / Q000097:blood*; D006801:Humans; D007333:Insulin Resistance; D008055:Lipids / Q000097:blood; D008875:Middle Aged; D053244:Osteoprotegerin / Q000097:blood; D017698:Postmenopause; D012107:Research Design; D012307:Risk Factors
chemical_list: D008055:Lipids; D053244:Osteoprotegerin; D006710:Homocysteine; D002762:Cholecalciferol; D019833:Genistein; D002119:Calcium Carbonate