title: Probiotic Soy Product Supplemented with Isoflavones Improves the Lipid Profile of Moderately Hypercholesterolemic Men: A Randomized Controlled Trial.
abstract: BACKGROUND
  Cardiovascular disease is the leading cause of worldwide morbidity and mortality. Several studies have demonstrated that specific probiotics affect the host's metabolism and may influence the cardiovascular disease risk.
  
  
  OBJECTIVE
  The aim of this study was to investigate the influence of an isoflavone-supplemented soy product fermented with Enterococcus faecium CRL 183 and Lactobacillus helveticus 416 on cardiovascular risk markers in moderately hypercholesterolemic subjects.
  
  
  METHODS
  Randomized placebo-controlled double-blind trial Setting: São Paulo State University in Araraquara, SP, Brazil.
  
  
  METHODS
  49 male healthy men with total cholesterol (TC) >5.17 mmol/L and <6.21 mmol/L Intervention: The volunteers have consumed 200 mL of the probiotic soy product (group SP-10(10) CFU/day), isoflavone-supplemented probiotic soy product (group ISP-probiotic plus 50 mg of total isoflavones/100 g) or unfermented soy product (group USP-placebo) for 42 days in a randomized, double-blind study.
  
  
  METHODS
  Lipid profile and additional cardiovascular biomarkers were analyzed on days 0, 30 and 42. Urine samples (24 h) were collected at baseline and at the end of the experiment so as to determine the isoflavones profile.
  
  
  RESULTS
  After 42 days, the ISP consumption led to improved total cholesterol, non-HDL-C (LDL + IDL + VLDL cholesterol fractions) and electronegative LDL concentrations (reduction of 13.8%, 14.7% and 24.2%, respectively, p < 0.05). The ISP and SP have prevented the reduction of HDL-C level after 42 days. The C-reactive protein and fibrinogen levels were not improved. The equol production by the ISP group subjects was inversely correlated with electronegative LDL concentration.
  
  
  CONCLUSIONS
  The results suggest that a regular consumption of this probiotic soy product, supplemented with isoflavones, could contribute to reducing the risk of cardiovascular diseases in moderately hypercholesterolemic men, through the an improvement in lipid profile and antioxidant properties.
authors.affiliation: Departamento de Alimentos e Nutrição, Faculdade de Ciências Farmacêuticas, UNESP-Univ Estadual Paulista, Araraquara-SP 14801-902, Brasil. cavallinidc@fcfar.unesp.br.
authors.forename: Daniela Cardoso Umbelino
authors.initials: DC
authors.lastname: Cavallini
authors.affiliation: Departamento de Alimentos e Nutrição, Faculdade de Ciências Farmacêuticas, UNESP-Univ Estadual Paulista, Araraquara-SP 14801-902, Brasil. mamanzoni@hotmail.com.
authors.forename: Marla Simone Jovenasso
authors.initials: MS
authors.lastname: Manzoni
authors.affiliation: Department of Biochemical and Pharmaceutical Technology, School of Pharmaceutical Sciences, University of São Paulo, São Paulo 05508900, Brazil. raquelbedani@yahoo.com.br.
authors.forename: Raquel
authors.initials: R
authors.lastname: Bedani
authors.affiliation: Departamento de Alimentos e Nutrição, Faculdade de Ciências Farmacêuticas, UNESP-Univ Estadual Paulista, Araraquara-SP 14801-902, Brasil. mari_roselino@yahoo.com.br.
authors.forename: Mariana Nougalli
authors.initials: MN
authors.lastname: Roselino
authors.affiliation: Departamento de Alimentos e Nutrição, Faculdade de Ciências Farmacêuticas, UNESP-Univ Estadual Paulista, Araraquara-SP 14801-902, Brasil. larissasbaglia@gmail.com.
authors.forename: Larissa Sbaglia
authors.initials: LS
authors.lastname: Celiberto
authors.affiliation: Departamento de Análises Clínicas, Faculdade de Ciências Farmacêuticas, UNESP-Univ Estadual Paulista, Araraquara-SP 14801-902, Brasil. vendrasp@fcfar.unesp.br.
authors.forename: Regina Célia
authors.initials: RC
authors.lastname: Vendramini
authors.affiliation: Reference Center for Lactobacilli, CERELA, S.M. Tucuman T4000ILC, Argentina. gfont@cerela.org.ar.
authors.forename: Graciela  Font
authors.initials: G
authors.lastname: de Valdez
authors.affiliation: Department of Clinical and Toxicological Analyses, School of Pharmaceutical Sciences, University of Sao Paulo, São Paulo 05508900, Brazil. dspabdalla@gmail.com.
authors.forename: Dulcinéia Saes Parra
authors.initials: DS
authors.lastname: Abdalla
authors.affiliation: Departamento de Alimentos e Nutrição, Faculdade de Ciências Farmacêuticas, UNESP-Univ Estadual Paulista, Araraquara-SP 14801-902, Brasil. rosely@fcfar.unesp.br.
authors.forename: Roseli Aparecida
authors.initials: RA
authors.lastname: Pinto
authors.affiliation: Departamento de Ciências Biológicas, Faculdade de Ciências Farmacêuticas, UNESP -Univ Estadual Paulista, Araraquara-SP 14801-902, Brasil. daniella.rossetto@gmail.com.
authors.forename: Daniella
authors.initials: D
authors.lastname: Rosetto
authors.affiliation: Departamento de Ciências Biológicas, Faculdade de Ciências Farmacêuticas, UNESP -Univ Estadual Paulista, Araraquara-SP 14801-902, Brasil. valentsr@fcfar.unesp.br.
authors.forename: Sandro Roberto
authors.initials: SR
authors.lastname: Valentini
authors.affiliation: Departamento de Alimentos e Nutrição, Faculdade de Ciências Farmacêuticas, UNESP-Univ Estadual Paulista, Araraquara-SP 14801-902, Brasil. rossiea@fcfar.unesp.br.
authors.forename: Elizeu Antonio
authors.initials: EA
authors.lastname: Rossi
mesh_terms: D000328:Adult; D000975:Antioxidants / Q000008:administration & dosage; D015415:Biomarkers / Q000097:blood / Q000652:urine; D002318:Cardiovascular Diseases / Q000209:etiology / Q000517:prevention & control; D002784:Cholesterol / Q000097:blood; D008076:Cholesterol, HDL / Q000187:drug effects; D008078:Cholesterol, LDL / Q000187:drug effects; D019587:Dietary Supplements; D004311:Double-Blind Method; D064368:Healthy Volunteers; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood / Q000150:complications / Q000178:diet therapy*; D007529:Isoflavones / Q000008:administration & dosage* / Q000652:urine; D008055:Lipids / Q000097:blood*; D008297:Male; D008875:Middle Aged; D019936:Probiotics / Q000008:administration & dosage*; D012307:Risk Factors; D045730:Soy Foods / Q000382:microbiology*
chemical_list: D000975:Antioxidants; D015415:Biomarkers; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D007529:Isoflavones; D008055:Lipids; D002784:Cholesterol
keywords: Enterococcus faecium CRL183; fermented soy product; isoflavones; lipid profile; probiotic