title: Isoflavone soy protein supplementation and atherosclerosis progression in healthy postmenopausal women: a randomized controlled trial.
abstract: OBJECTIVE
  Although epidemiological and experimental studies suggest that dietary intake of soy may be cardioprotective, use of isoflavone soy protein (ISP) supplementation as a primary preventive therapy remains unexplored. We determined whether ISP reduces subclinical atherosclerosis assessed as carotid artery intima-media thickness progression.
  
  
  METHODS
  In a double-blind, placebo-controlled trial, 350 postmenopausal women 45 to 92 years of age without diabetes and cardiovascular disease were randomized to 2 evenly divided daily doses of 25 g soy protein containing 91 mg aglycon isoflavone equivalents or placebo for 2.7 years.
  
  
  RESULTS
  Overall, mean (95% CI) carotid artery intima-media thickness progression rate was 4.77 (3.39-6.16) μm/year in the ISP group and 5.68 (4.30-7.06) μm/year in the placebo group. Although carotid artery intima-media thickness progression was reduced on average by 16% in the ISP group relative to the placebo group, this treatment effect was not statistically significant (P=0.36). Among the subgroup of women who were randomized within 5 years of menopause, ISP participants had on average a 68% lower carotid artery intima-media thickness progression rate than placebo participants 2.16 (-1.10 to 5.43) versus 6.79 (3.56-10.01) μm/year (P=0.05). ISP supplementation had a null effect on women who were >5 years beyond menopause when randomized. There were no major adverse events from ISP supplementation.
  
  
  CONCLUSIONS
  ISP supplementation did not significantly reduce subclinical atherosclerosis progression in postmenopausal women. Subgroup analysis suggests that ISP supplementation may reduce subclinical atherosclerosis in healthy young (median age, 53 years) women at low-risk for cardiovascular disease who were <5 years postmenopausal. These first trial results of their kind warrant further investigation.
authors: USC Keck School of Medicine, Atherosclerosis Research Unit, 2250 Alcazar Street, CSC132, Los Angeles, CA 90033, USA. athero@usc.edu
authors: Howard N
authors: HN
authors: Hodis
authors: Wendy J
authors: WJ
authors: Mack
authors: Naoko
authors: N
authors: Kono
authors: Stanley P
authors: SP
authors: Azen
authors: Donna
authors: D
authors: Shoupe
authors: Juliana
authors: J
authors: Hwang-Levine
authors: Diana
authors: D
authors: Petitti
authors: Lora
authors: L
authors: Whitfield-Maxwell
authors: Mingzhu
authors: M
authors: Yan
authors: Adrian A
authors: AA
authors: Franke
authors: Robert H
authors: RH
authors: Selzer
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D050197:Atherosclerosis / Q000453:epidemiology* / Q000473:pathology* / Q000517:prevention & control; D019587:Dietary Supplements; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007529:Isoflavones / Q000008:administration & dosage*; D008875:Middle Aged; D017698:Postmenopause; D030262:Soybean Proteins / Q000008:administration & dosage*
chemical_list: D007529:Isoflavones; D030262:Soybean Proteins