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Abstract：
BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) accounts as a crucial health concern with a huge burden on health and economic systems. The aim of this study is to evaluate the effect of soy isoflavones supplementation on metabolic status in patients with NAFLD.
METHODS: In this randomized clinical trial, 50 patients with NAFLD were randomly allocated to either soy isoflavone or placebo groups for 12 weeks. The soy isoflavone group took 100 mg/d soy isoflavone and the placebo group took the similar tablets containing starch. Anthropometric indices, blood lipids, glycemic parameters and blood pressure were measured at the beginning and at the end of the study.
RESULTS: At the end of week 12 the level of serum triglyceride (TG), low density lipoprotein (LDL) and total cholesterol (TC) was significantly decreased only in soy isoflavone group compared to baseline (P < 0.05). Although waist circumference (WC) decreased significantly in both groups after 12 weeks of intervention (P < 0.05), hip circumference (HC) decreased significantly only in soy isoflavone group (P = 0.001). No significant changes observed regarding high density lipoprotein (HDL) and blood pressure in both groups. At the end of the study, serum glucose level was significantly decreased in the placebo group compared to baseline (P = 0.047). No significant changes demonstrated in the soy isoflavone group in regard to glycemic parameters (P > 0.05).
CONCLUSIONS: This study revealed that soy isoflavones could significantly reduce TG, LDL TC, WC and HC in NAFLD patients.
BACKGROUND: The Ethics committee of Ahvaz Jundishapur University of Medical Sciences approved the protocol of the present clinical research (IR.AJUMS.REC.1401.155). The study was in accordance with the Declaration of Helsinki. This study\'s registered number and date are IRCT20220801055597N1 and 20.09.2022, respectively at https://fa.irct.ir .
METHODS: In this randomized clinical trial, 50 patients with NAFLD were randomly allocated to either soy isoflavone or placebo groups for 12 weeks. The soy isoflavone group took 100 mg/d soy isoflavone and the placebo group took the similar tablets containing starch. Anthropometric indices, blood lipids, glycemic parameters and blood pressure were measured at the beginning and at the end of the study.
RESULTS: At the end of week 12 the level of serum triglyceride (TG), low density lipoprotein (LDL) and total cholesterol (TC) was significantly decreased only in soy isoflavone group compared to baseline (P < 0.05). Although waist circumference (WC) decreased significantly in both groups after 12 weeks of intervention (P < 0.05), hip circumference (HC) decreased significantly only in soy isoflavone group (P = 0.001). No significant changes observed regarding high density lipoprotein (HDL) and blood pressure in both groups. At the end of the study, serum glucose level was significantly decreased in the placebo group compared to baseline (P = 0.047). No significant changes demonstrated in the soy isoflavone group in regard to glycemic parameters (P > 0.05).
CONCLUSIONS: This study revealed that soy isoflavones could significantly reduce TG, LDL TC, WC and HC in NAFLD patients.
BACKGROUND: The Ethics committee of Ahvaz Jundishapur University of Medical Sciences approved the protocol of the present clinical research (IR.AJUMS.REC.1401.155). The study was in accordance with the Declaration of Helsinki. This study\'s registered number and date are IRCT20220801055597N1 and 20.09.2022, respectively at https://fa.irct.ir .
摘要：
背景：非酒精性脂肪性肝病（NAFLD）是一个至关重要的健康问题，对健康和经济系统造成巨大负担。这项研究的目的是评估大豆异黄酮补充剂对NAFLD患者代谢状态的影响。
方法：在这项随机临床试验中，50名NAFLD患者随机分为大豆异黄酮组或安慰剂组，为期12周。大豆异黄酮组服用100mg/d大豆异黄酮，安慰剂组服用类似的含淀粉片剂。人体测量指数,血脂,在研究开始和结束时测量血糖参数和血压.
结果：在第12周结束时，血清甘油三酯（TG）水平，与基线相比，大豆异黄酮组低密度脂蛋白（LDL）和总胆固醇（TC）显着降低（P<0.05）。干预12周后,两组患者的腰围均显著下降(P<0.05)。仅大豆异黄酮组的臀围（HC）显着降低（P=0.001）。两组的高密度脂蛋白（HDL）和血压均无明显变化。在研究结束时,与基线相比,安慰剂组的血清葡萄糖水平显著降低(P=0.047).大豆异黄酮组的血糖参数没有显著变化(P>0.05)。
结论：这项研究表明，大豆异黄酮可以显着降低TG，LDLTC,NAFLD患者的WC和HC。
背景：AhvazJundishapur医科大学的伦理委员会批准了本临床研究的方案（IR。JUMS.REC.1401.155).这项研究符合《赫尔辛基宣言》。本研究的注册编号和日期分别为IRCT20220801055597N1和20.09.2022，网址为https://fa。irct.Ir.
方法：在这项随机临床试验中，50名NAFLD患者随机分为大豆异黄酮组或安慰剂组，为期12周。大豆异黄酮组服用100mg/d大豆异黄酮，安慰剂组服用类似的含淀粉片剂。人体测量指数,血脂,在研究开始和结束时测量血糖参数和血压.
结果：在第12周结束时，血清甘油三酯（TG）水平，与基线相比，大豆异黄酮组低密度脂蛋白（LDL）和总胆固醇（TC）显着降低（P<0.05）。干预12周后,两组患者的腰围均显著下降(P<0.05)。仅大豆异黄酮组的臀围（HC）显着降低（P=0.001）。两组的高密度脂蛋白（HDL）和血压均无明显变化。在研究结束时,与基线相比,安慰剂组的血清葡萄糖水平显著降低(P=0.047).大豆异黄酮组的血糖参数没有显著变化(P>0.05)。
结论：这项研究表明，大豆异黄酮可以显着降低TG，LDLTC,NAFLD患者的WC和HC。
背景：AhvazJundishapur医科大学的伦理委员会批准了本临床研究的方案（IR。JUMS.REC.1401.155).这项研究符合《赫尔辛基宣言》。本研究的注册编号和日期分别为IRCT20220801055597N1和20.09.2022，网址为https://fa。irct.Ir.
