Discussion
T2DM, TG, tumor necrosis
TUMOR NECROSIS
This randomized double-blind clinical trial aimed to examine the effects of soymilk and probiotics supplement co-administration on cardiovascular risk factors in patients with T2DM. The results showed soymilk plus probiotics supplement consumption significantly improved DBP, TC, TG, HDL-C, and insulin levels after 6 weeks of treatment. Also, soymilk consumption had significant beneficial effects on DBP, TG, HDL-C, and insulin levels. Moreover, probiotics supplementation significantly improved the levels of SBP, HDL-C, and insulin. The results of between-group comparisons showed that probiotics supplement significantly reduced SBP levels compared to conventional milk. As far as we know the majority of previous studies focused on fermented soymilk with specific probiotics and no studies have been conducted on soymilk plus probiotics co-administration.In this study, we failed to show a significant difference in the reduction of anthropometric measurements, blood pressure, lipid profiles, and glucose tolerance indices by soymilk between the study's groups. However, within-group comparison showed significant beneficial effects of soymilk on DBP, TG, HDL-C, and insulin levels. A systematic review and meta-analysis investigated the effects of soymilk consumption on cardiovascular risk factors and reported inconsistent findings. Accordingly, soymilk consumption significantly decreased SBP, DBP, TC, LDL-C, waist circumference (WC), C-reactive protein (CRP), and tumor necrosis factor-alpha compared to the control group. However, it was not effective in the reduction of other risk factors including body weight, BMI, HDL-C, TG, FBS, and fasting insulin. The results differed from ours because the authors did not take into account the health status of the subjects and pooled data from healthy and sick subjects in the analysis. Also, none of the primary studies included in the meta-analyses were performed on patients with T2DM [In our study, probiotics supplementations significantly improved the levels of SBP, HDL-C, and insulin after 6 weeks of intervention. The results of between-group comparisons also showed that probiotics supplement significantly reduced SBP levels compared to conventional milk. In a systematic review and meta-analysis of 13 RCTs, the authors found that multi-strain probiotics supplementation compared to the control group significantly improved FBS, HOMA-IR, TC, TG, SBP, and DBP, but not HbA1c, fasting insulin, HDL-C, and LDL-C [Finally, this study indicated that soymilk plus probiotics supplement consumption significantly improved DBP, TC, TG, HDL-C, and insulin levels after 6 weeks of treatment. However, between-group comparisons didn't show significant differences. Few RCTs have investigated the effects of fermented soymilk on cardiovascular risk factors [This study has some strengths. As far as we know this study for the first time has investigated the effects of soymilk plus probiotics supplement in patients with T2DM. Also, in our study, the effectiveness of the main group (soymilk plus probiotics supplement) was compared with a control (conventional milk) and its two components (soymilk and probiotics). Moreover, compliance with the study protocol was assessed during and at the end of the study, and major confounders were controlled for in the analyses. Like any other study, our study also has some limitations. First, our study seems to have a short duration which resulted in non-significant results. Second, the isoflavone content of the soymilks was not assessed. Third, we haven’t evaluated the survival rate of probiotics bacteria during passage through the gastrointestinal tract.