Probiotic soy product supplemented with isoflavones Improves the lipid profile of moderately hypercholesterolemic men: a randomized controlled trial

Cardiovascular disease is the leading cause of worldwide morbidity andmortality. Several studies have demonstrated that specific probiotics affect the host?s metabolism and may influence the cardiovascular disease risk. Objectives: The aim of this study was to investigate theinfluence of an isoflavone-supplemented soy product fermented with Enterococcus faecium CRL 183 and Lactobacillus helveticus 416 on cardiovascular risk markers in moderately hypercholesterolemic subjects. Design: Randomized placebo-controlled double-blind trial Setting: São Paulo State University in Araraquara, SP, Brazil. Participants: 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-1010 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. Main outcome measures: Lipidprofile 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 cardiovasculardiseases in moderately hypercholesterolemic men, through the an improvement in lipid profile and antioxidant properties.Fil: Cavallini, Daniela Cardoso Umbelino. Universidade Estadual Paulista Julio de Mesquita Filho; BrasilFil: Manzoni, Marla Simone Jovenasso. Universidade Estadual Paulista Julio de Mesquita Filho; BrasilFil: Bedani, Raquel. Universidade de Sao Paulo; BrasilFil: Roselino, Mariana Nougalli. Universidade Estadual Paulista Julio de Mesquita Filho; BrasilFil: Celiberto, Larissa Sbaglia. Universidade Estadual Paulista Julio de Mesquita Filho; BrasilFil: Vendramini, Regina Célia. Universidade Estadual Paulista Julio de Mesquita Filho; BrasilFil: Font, Graciela Maria. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Tucuman. Centro de Referencia Para Lactobacilos; ArgentinaFil: Abdalla, Dulcinéia Saes Parra. Universidade de Sao Paulo; BrasilFil: Pinto, Roseli Aparecida. Universidade Estadual Paulista Julio de Mesquita Filho; BrasilFil: Rosetto, Daniella. Universidade Estadual Paulista Julio de Mesquita Filho; BrasilFil: Valentini, Sandro Roberto. Universidade Estadual Paulista Julio de Mesquita Filho; BrasilFil: Rossi, Elizeu Antonio. Universidade Estadual Paulista Julio de Mesquita Filho; Brasi