title: The effect of soy dietary supplement and low dose of hormone therapy on main cardiovascular health biomarkers: a randomized controlled trial.
abstract: OBJECTIVE
  To assess the effects of a soy dietary supplement on the main biomarkers of cardiovascular health in postmenopausal women compared with the effects of low-dose hormone therapy (HT) and placebo.
  
  
  METHODS
  Double-blind, randomized and controlled intention-to-treat trial. Sixty healthy postmenopausal women, aged 40-60 years, 4.1 years mean time since menopause were recruited and randomly assigned to 3 groups: a soy dietary supplement group (isoflavone 90mg), a low-dose HT group (estradiol 1 mg plus noretisterone 0.5 mg) and a placebo group. Lipid profile, glucose level, body mass index, blood pressure and abdominal/hip ratio were evaluated in all the participants at baseline and after 16 weeks. Statistical analyses were performed using the χ2 test, Fisher's exact test, Kruskal-Wallis non-parametric test, analysis of variance (ANOVA), paired Student's t-test and Wilcoxon test.
  
  
  RESULTS
  After a 16-week intervention period, total cholesterol decreased 11.3% and LDL-cholesterol decreased 18.6% in the HT group, but both did not change in the soy dietary supplement and placebo groups. Values for triglycerides, HDL-cholesterol, glucose level, body mass index, blood pressure and abdominal/hip ratio did not change over time in any of the three groups.
  
  
  CONCLUSIONS
  The use of dietary soy supplement did not show any significant favorable effect on cardiovascular health biomarkers compared with HT.
  
  
  BACKGROUND
  The trial is registered at the Brazilian Clinical Trials Registry (Registro Brasileiro de Ensaios Clínicos - ReBEC), number RBR-76mm75.
authors.affiliation: Department of Obstetrics and Gynecology, Universidade Estadual de Campinas, Campinas, SP, Brazil.
authors.forename: Lúcio Omar
authors.initials: LO
authors.lastname: Carmignani
authors.affiliation: Department of Obstetrics and Gynecology, Universidade Estadual de Campinas, Campinas, SP, Brazil.
authors.forename: Adriana Orcesi
authors.initials: AO
authors.lastname: Pedro
authors.affiliation: Department of Obstetrics and Gynecology, Universidade Estadual de Campinas, Campinas, SP, Brazil.
authors.forename: Lúcia Helena Simões
authors.initials: LH
authors.lastname: da Costa-Paiva
authors.affiliation: Department of Obstetrics and Gynecology, Universidade Estadual de Campinas, Campinas, SP, Brazil.
authors.forename: Aarão Mendes
authors.initials: AM
authors.lastname: Pinto-Neto
mesh_terms: D000328:Adult; D015415:Biomarkers / Q000097:blood; D002320:Cardiovascular Physiological Phenomena; D019587:Dietary Supplements; D004311:Double-Blind Method; D015914:Estrogen Replacement Therapy; D004967:Estrogens / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007529:Isoflavones / Q000008:administration & dosage*; D008875:Middle Aged; D045730:Soy Foods
chemical_list: D015415:Biomarkers; D004967:Estrogens; D007529:Isoflavones