Efeito da suplementação dietética com isoflavona da soja sobre a qualidade de vida e sintomas urogenitais do climatério: ensaio clínico randomizado controlado / Effect of a say-based dietary supplement with isoflavones on the quality of and urogenital symptoms of menopause: randomized contorlled clinical trial

Objetivos: Comparar dos efeitos da ingestão diária de um suplemento alimentar á base de isoflavona de soja, terapia hormonal (TH) de baixa dosagem e placebo sobre a qualidade de vida (QV) em mulheres sintomáticas na pós-menopausa e avaliar a correlação entre a melhora dos sintomas da menopausa e a QV de acordo com o tipo de tratamento e comparar os efeitos de cada uma das intervenções sobre o sistema urogenital da mulher na pós- menopausa.

To compare the effects of a soy-based dietary supplement, low-dose hormone therapy (HT) and placebo and on quality of life (QOL) of symptomatic postmenopausal women and to evaluate the correlation between the improvement in menopausal symptoms and QOL according to treatment type and, also assess the effects of each intervention on the urogenital systems in postmenopausal women. Methods: This was a double-blind, randomized and placebo-controlled clinical trial. Sixty healthy postmenopausal women,aged 40 - 60, were recruited and randomly assigned to three groups

The effect of soy dietary supplement and low dose of hormone therapy on main cardiovascular health biomarkers: a randomized controlled trial.

PURPOSE: 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. CONCLUSION: The use of dietary soy supplement did not show any significant favorable effect on cardiovascular health biomarkers compared with HT. CLINICAL TRIAL REGISTRY: The trial is registered at the Brazilian Clinical Trials Registry (Registro Brasileiro de Ensaios Clínicos - ReBEC), number RBR-76mm75.

The effect of soy dietary supplement and low dose of hormone therapy on main cardiovascular health biomarkers: a randomized controlled trial / O efeito de um suplemento alimentar à base de soja e terapia hormonal em baixa dose sobre os principais marcadores de risco cardiovascular: ensaio clínico randomizado controlado

PURPOSE: 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. CONCLUSION: The use of dietary soy supplement did not show any significant favorable effect on cardiovascular health biomarkers compared with HT. Clinical Trial Registry: The trial is registered at the Brazilian Clinical Trials Registry (Registro Brasileiro de Ensaios Clínicos - ReBEC), number RBR-76mm75. .

OBJETIVO: Avaliar os efeitos do uso de um suplemento alimentar à base de soja sobre os principais marcadores de risco cardiovascular e compará-los com o uso da terapia hormonal (TH) de baixa dose e grupo placebo em mulheres na pós-menopausa. MÉTODOS: Foram selecionadas 60 participantes do ambulatório de menopausa com idade entre 40 e 60 anos, com idade média de 4,1 anos na menopausa para participar de um ensaio clínico randomizado, duplo-cego e controlado com duração de 16 semanas. As pacientes foram randomizadas em 3 grupos: um grupo que recebeu suplemento dietético à base de soja (isoflavona 90 mg), um grupo que recebeu TH em baixa dose (estradiol 1 mg e noretisterona 0,5 mg) e um grupo placebo. Os seguintes parâmetros foram avaliados no início e ao término das 16 semanas de intervenção: perfil lipídico, glicemia de jejum, índice de massa corpórea, pressão sanguínea arterial e circunferência abdominal. A análise estatística foi realizada usando-se o teste do χ2, teste exato de Fisher, teste não paramétrico de Kruskal-Wallis, análise de variância (ANOVA), teste t de Student pareado e teste de Wilcoxon. RESULTADOS: Ao final do período de intervenção de 16 semanas, houve uma diminuição do colesterol total em 11,3% e do LDL-colesterol em 18,6% no grupo da TH, porém ambos não tiveram mudanças tanto no grupo do suplemento alimentar à base de soja quanto no grupo placebo. Os valores de triglicérides, HDL-colesterol, glicemia de jejum, índice de massa corpórea, pressão sanguínea arterial e circunferência abdominal não mudaram ao longo da intervenção em nenhum dos grupos estudados. CONCLUSÃO: Do ponto de vista cardiovascular, o suplemento alimentar à base de soja não mostrou efeito ...