Effects of the phytoestrogen genistein on some predictors of cardiovascular risk in osteopenic, postmenopausal women: a two-year randomized, double-blind, placebo-controlled study.
BACKGROUND
Genistein, a soy isoflavone, has received wide attention over the last few years because of its potential preventive role for cardiovascular disease.


OBJECTIVE
Our objective was to assess the effects of genistein administration (54 mg/d) on some predictors of cardiovascular risk in osteopenic, postmenopausal women.


METHODS
We conducted a randomized, double-blind, placebo-controlled trial at three Italian university medical centers.


METHODS
After a 4-wk stabilization on a standard isocaloric, fat-reduced diet, participants were randomly assigned to receive genistein (n = 198) or placebo (n = 191) daily for 24 months. Both intervention and placebo contained calcium and vitamin D(3).


METHODS
Blood lipid profiles, fasting glucose and insulin, homeostasis model assessment for insulin resistance, fibrinogen, soluble intercellular adhesion molecule-1, soluble vascular cellular adhesion molecule-1, F2-isoprostanes, and osteoprotegerin at baseline and after 12 and 24 months of treatment were measured.


RESULTS
Compared with placebo, genistein significantly reduced fasting glucose and insulin as well as homeostasis model assessment for insulin resistance after both 12 and 24 months of treatment. By contrast, genistein administration did not affect blood lipid levels although fibrinogen, F2-isoprostanes, soluble intercellular adhesion molecule-1, and soluble vascular cellular adhesion molecule-1 decreased significantly compared with placebo after 24 months. Serum osteoprotegerin was higher in the genistein group compared with placebo. At 24 months, the genistein group showed no change in endometrial thickness compared with placebo. Most treatment-related adverse events were moderate and composed of gastrointestinal side effects [genistein, n = 37 (19%); placebo, n = 15 (8%)].


CONCLUSIONS
These results suggest that 54 mg genistein plus calcium, vitamin D(3), and a healthy diet was associated with favorable effects on both glycemic control and some cardiovascular risk markers in a cohort of osteopenic, postmenopausal women.
Department of Internal Medicine, University of Messina, Italy.
Marco
M
Atteritano
Herbert
H
Marini
Letteria
L
Minutoli
Francesca
F
Polito
Alessandra
A
Bitto
Domenica
D
Altavilla
Susanna
S
Mazzaferro
Rosario
R
D'Anna
Maria Letizia
ML
Cannata
Agostino
A
Gaudio
Alessia
A
Frisina
Nicola
N
Frisina
Francesco
F
Corrado
Francesco
F
Cancellieri
Carla
C
Lubrano
Michele
M
Bonaiuto
Elena Bianca
EB
Adamo
Francesco
F
Squadrito
D000368:Aged; D015415:Biomarkers; D001786:Blood Glucose / Q000378:metabolism; D015519:Bone Density; D001851:Bone Diseases, Metabolic / Q000097:blood / Q000150:complications*; D002318:Cardiovascular Diseases / Q000097:blood / Q000517:prevention & control*; D004032:Diet; D004311:Double-Blind Method; D005260:Female; D005340:Fibrinogen / Q000378:metabolism; D019833:Genistein / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007328:Insulin / Q000097:blood; D018799:Intercellular Adhesion Molecule-1 / Q000097:blood; D028421:Isoprostanes / Q000097:blood; D008055:Lipids / Q000097:blood; D008875:Middle Aged; D053244:Osteoprotegerin / Q000097:blood; D017698:Postmenopause / Q000502:physiology*; D012307:Risk Factors; D016896:Treatment Outcome; D014463:Ultrasonography; D014599:Uterus / Q000000981:diagnostic imaging; D019010:Vascular Cell Adhesion Molecule-1 / Q000097:blood
D015415:Biomarkers; D001786:Blood Glucose; D007328:Insulin; D028421:Isoprostanes; D008055:Lipids; D053244:Osteoprotegerin; D019010:Vascular Cell Adhesion Molecule-1; D018799:Intercellular Adhesion Molecule-1; D005340:Fibrinogen; D019833:Genistein