Research protocol: effect of natural S-equol on blood pressure and vascular function--a six-month randomized controlled trial among equol non-producers of postmenopausal women with prehypertension or untreated stage 1 hypertension.

BACKGROUND: Although higher habitual soy intake is associated with lower blood pressure (BP) and stroke incidence, clinical trials using soy protein or isoflavones on cardiovascular risks yielded inconsistent results. The discrepancies are hypothesized to be due to the individuals' intestinal bacterial capacity to metabolite isoflavones daidzein into equol. Animal and in vitro studies have revealed that equol has stronger estrogen-like and anti-oxidative activity than isoflavones and possesses natriuretic and vasorelaxant properties which may play an important role in the prevention of hypertension. However, no clinical trial has examined the effect of equol on BP. We thus propose a 24-week randomized controlled trial to test the effectiveness of natural S-equol on BP and vascular function among equol non-producers. METHODS/DESIGN: This will be a 6-month double-blind, randomized, placebo-controlled trial among 207 non-equol producing postmenopausal women with prehypertension or early untreated hypertension. Eligible participants who have completed a 2-week run-in will be randomized to either one of the 3 groups: placebo group, low-equol group (10 mg/d) and high equol group (20 mg/d). The outcome measures will be conducted at baseline and at the end of the trial including 24 h ambulatory BP, endothelial function (by ultrasound determined brachial flow mediated dilation), arterial stiffness (by pulse wave analysis) and other cardiovascular risk factors (lipid profile, glycemic control and inflammatory biomarkers). Urinary isoflavones will be tested for compliance assessment. One way analysis of variance will be applied to compare the 6-month changes in ambulatory BP or parameters of vascular function among the 3 treatment groups. DISCUSSION: This study will be performed in community subjects. If the antihypertensive effect of equol is proven, the provision of natural equol to those high risk adults who are unable to produce equol will have enormous public health implications for the primary and secondary prevention of hypertension and cardiovascular diseases on a population basis. The research efforts will also have significant implications for industry in the provision of suitable soy products for the prevention of hypertension and its related complications. TRIAL REGISTRATION: The trial was registered in ClinicalTrials.gov with identifier of NCT02515682 .

[Chinese medicine formula 1 regulating immunity and anti-oxidation experiments in mice].

OBJECTIVE: To observe the effect of immunoregulation and anti-oxidation of Zhongyaofangji NO1 (ZYFJ). METHODS: 1. SPF BALB/C mice were randomly divided into control group (distilled water), positive control group (Broken Spore), ZYFJ low dose group (0.35 g/kg), middle dose group (0.70 g/kg) and high dose group (1.40 g/kg), with intragastric administration 1 time/d for 30d; The spleen and thymus index, ability of spleen lymphocyte proliferation, phagocytosing chicken red blood cell (CRBC) of abdominal macrophage cell, carbon clearance were investigated. 2. SPF BALB/C mice were divided into normal control group, model control group (D-galactose induced peroxidation damage), model plus ZYFJ low dose, middle dose and high dose group, model plus positive control group (Broken Spore), with drug administration 1 time/d for 30 d. SOD activity, MDA and LPO content in brain tissue were tested while Nrf2 [Nuclear factor (erythroi D-derived 2)-like 2] protein expression in brain tissue nucleus was tested by western blotting. RESULTS: The thymus index and spleen index in groups of ZYFJ high dose and positive control were higher than those in control group, the ability of lymphocyte proliferation and phagocytosis of macrophages were increased in all the other groups significantly compared with control group; The activity of SOD and Nrf2 protein expression level in brain tissue of model mice was increased, MDA and LPO contents were reduced in ZYFJ middle and high dose as well as positive control significantly, while the MDA content was reduced and Nrf2 protein was increased in low dose group. CONCLUSION: Appropriate dose of ZYFJ1 has good effect of immunoregulation, and plays a role of anti-oxidation probably by regulating Nrf2 protein expression in brain tissue and related signaling pathway.

[Study on antidepressant effect of kuanxinjieyutang combined aerobic exercise].

OBJECTIVE: To observe antidepressant effects of Kuanxinjieyutang (KXJYT), short-term aerobic exercise and their joint intervention and its possible mechanism. METHODS: Ninty-six SPF male KM mice were randomly divided into control group, imipramine, low dose (KXJYT 1.8 g crude drugs/kg bw/time/day), high dose (3.6 g crude drugs/kg bw/time/day), exercise group (swimming 30 min/times/day), joint group (low dose and swimming ), with 8 days intervention. The antidepressant effect was evaluated by forced swimming, tail suspension test and overhead cross maze test. After mice were killed, brain monoamine neurotransmitter levels of mice were detected by ELISA, and BDNF expression in brain was analyzed by Western blotting. RESULTS: High dose group showed antidepressant effect like imipramine while low dose didn't. Exercise group showed similar or better antidepressant effect than imipramine. Joint group showed better interaction antidepressant effect. Brain NE, DA of high dose group and brain NE, DA and 5-HT content of exercise group increased significantly, similar to imipramine. Brain NE,DA and 5-HT content of Joint group were significantly higher than those of imipramine. The protein expression of BDNF in brain was more in imipramine, high dose,exercise and joint groups than that of control group, sports group was higher than that of low dose and high dose group, joint group was obviously higher than other groups. CONCLUSION: Moderate KXJYT, short-term aerobic exercise and their joint intervention have obvious antidepressant effect on mild depression. Its mechanism may be related to increasing brain NE and 5-HT content, and inducing brain BDNF expression, which may affect the nerve regeneration and plasticity, improve cognitive function.

Systematic review and meta-analysis: Tai Chi for preventing falls in older adults.

OBJECTIVE: It remains unclear whether Tai Chi is effective for preventing falls in older adults. We undertook this systematic review to evaluate the preventive effect of Tai Chi by updating the latest trial evidence. DESIGN: Systematic review and meta-analysis. METHODS: The Cochrane Library, MEDLINE and EMBASE were searched up to February 2016 to identify randomised trials evaluating Tai Chi for preventing falls in older adults. We evaluated the risk of bias of included trials using the Cochrane Collaboration's tool. Results were combined using random effects meta-analysis. OUTCOME MEASURES: Number of fallers and rate of falls. RESULTS: 18 trials with 3824 participants were included. The Tai Chi group was associated with significantly lower chance of falling at least once (risk ratio (RR) 0.80, 95% CI 0.72 to 0.88) and rate of falls (incidence rate ratio (IRR) 0.69, 95% CI 0.60 to 0.80) than the control group. Subgroup analyses suggested that the preventive effect was likely to increase with exercise frequency (number of fallers: p=0.001; rate of falls: p=0.007) and Yang style Tai Chi was likely to be more effective than Sun style Tai Chi (number of fallers: p=0.01; rate of falls: p=0.001). The results might be influenced by publication bias as the funnel plots showed asymmetry. Sensitivity analyses by sample size, risk of bias and comorbidity showed no major influence on the primary results. CONCLUSIONS: Tai Chi is effective for preventing falls in older adults. The preventive effect is likely to increase with exercise frequency and Yang style Tai Chi seems to be more effective than Sun style Tai Chi.