A Clinical Trial For Obese PCOS By Intervening The Gut Microbiota-targeted Nutrition

ObjectivePolycystic ovary syndrome is a common heterogeneous endocrine and chronic metabolic disease affecting the reproductive-aged women and has a major impact on reproductive health.It has a variety of clinical manifestations like anovulatory infertility and metabolic diseases including obesity,impaired glucose tolerance,metabolic syndrome and cardiovascular disease.In recent years,the diagnosis and treatment of PCOS has not only been focus on menstrual disorders and infertility,but metabolic abnormalities have become a hot research topic of PCOS.A complex community of microorganisms resides within the large intestine(the gut microbiome)that is important for human health.Correlative studies demonstrated that the gut microbiome of individuals with metabolic disorders,such as obesity and dyslipidemia,differs from healthy individuals.WTP diet can improve blood glucose and lipid levels by changing the structure of gut microbiota.However,the role of the gut microbiome in the pathogenesis and metabolic abnormalities of PCOS remains unclear.A better understanding of the relationship between PCOS and the gut microbiome in women may lead to new therapeutic approaches for PCOS.Methods16 obese PCOS women(BMI?25 kg/m~2)at the gynecological clinic of Henan Provincial People's Hospital will be recruited into a dietary intervention for 3 months as the experiment group.In the experimental group,PCOS patients will only receive a microbiota-targeted diet intervention based on whole grains,traditional Chinese medicinal foods,and probiotics(WTP diet intervention)and have a record every day.Meanwhile they will be guided supervised by professional nutritionist.Feces,blood samples,anthropometric data and clinical laboratory analysis are obtained at baseline and every month during the intervention.Blood samples are collected after overnight fasting and then stood at room temperature for 30 min.Then they will be centrifuged at 3,000 rpm for 15 minutes to obtain serum.The serum are used to detect the level of sex hormones,blood lipids,blood glucose and insulin.The feces are collected on the same day and immediately frozen on dry ice upon collection and stored at-80°C until further sequenced analysis.Results1.Compared with pre-dietary intervention,the menstruation of obese patients with PCOS is shortened after intervention.Besides,the levels of T and LH/FSH in PCOS patients are decreased and FSH is increased significantly(P<0.05);2.The fasting blood glucose,fasting blood insulin,OGTT AUC,Insulin AUC and HOMA-IR of patients are reduced after dietary intervention significantly(P<0.05);3.Compared with pre-dietary intervention,their body weight,BMI and the Rosenfield scores also decreased significantly.The TC,TG and LDL of the patients showed a downward trend after the dietary intervention while the HDL showed an upward trend;4.With the prolongation of dietary intervention,the alpha diversity and abundance of gut microbiome increased,especially the Actinobacteria.Especially,the diversity is associated with the weight loss.Conclusion1.Gut microbiome is associated with clinical manifestations of obese PCOS patients such as menstrual thinning,obesity,impaired glucose tolerance,dyslipidemia,and hyperandrogenism.2.The microbiota-targeted dietary intervention can increase the Alpha diversity of gut microbiome in obese PCOS patients and help to modulate the clinical symptoms of PCOS patients with obesity.Besides,it can be a potential method to be an adjuvant therapy for enhanced effects on PCOS patients' health.