| Objective1.To evaluate the effects of quality high-protein diet combined with metformin on menstrual cycle,hyperandrogenemia,body composition analyzer,sex hormone,glucose metabolism,lipid metabolism,hepatic and renal function,color ultrasound of uterus and ovary and other clinical outcomes of PCOS patients.2.Using metabolomics analysis to analyze the metabolic responses of patients that received quality high-protein diet combined with metformin,and to evaluate the efficacy and explore metabolic pathways preliminarily.Methods1.The study included 45 patients with polycystic ovary syndrome(PCOS)who visited the PCOS special clinic of Nanjing Drum Tower Hospital during February 2021 to February 2022.The patients were divided into two groups randomly using random number table: quality high-protein diet combined with metformin(experimental group)and normal diet combined with metformin(control group).A doctor of clinical nutrition department formulated a diet and exercise program for the patients who were required to record the chart of food and exercise every day.We followed up the patients through Wechat once a week,and the patients returned visit each mouth.The treatment lasted for 12 weeks.After treatment,we recorded and analyzed the data of before and after treatment to evaluate the efficacy and safety,including the recovery rate of menstrual cycle and hyperandrogenemia,body composition analyzer,sex hormone,glucose metabolism,lipid metabolism,hepatic and renal function,color ultrasound of uterus and ovary and other clinical outcomes.2.The study selected 6 patients with PCOS who visited the PCOS special clinic of Nanjing Drum Tower Hospital during February 2021 to February 2022.The patients were treated for 12 weeks on quality high-protein diet(C: P: F=40:30:30)combined with exercise(moderate intensity exercise 150 min per week)and metformin(1000mg/day).We collected the serum samples to analyze the variation of clinical indicators of sex hormone,glucose metabolism and lipid metabolism,body composition analyzer before and after treatment,and using GC-MS non-target metabolomics analysis the serum samples to find the differential metabolites and metabolic pathways.ResultsPart 1(1)There were no significant differences in baseline datas between the experimental group and the control group,so the two groups were comparable(p >0.05).(2)After 12 weeks,menstrual disorder and hyperandrogenemia were both improved,and the effect in experimental group was more significant than that in control group(p <0.05).(3)In body composition analysis,the experimental group showed decreases obviously in weight,muscle mass,body fat,BMI,body fat percentage,waist-to-hip fat ratio,obesity degree,visceral fat area and basal metabolism(all p <0.05).In experimental group,body weight,muscle mass,BMI and basal metabolism decreased more significantly(p <0.05)compared with the control group.We further analyzed the distribution of muscle and fat mass,and found that the muscle mass of both upper limbs and trunk in the experimental group decreased significantly(p <0.005).The fat mass of extremities and trunk in experimental group decreased evenly(all p <0.05),and trunk fat content decreased more significantly(p <0.005).In the control group,the decrease of fat mass was mainly in lower limbs(p<0.05).Compared with the control group,the muscle mass of upper limbs and trunk in experimental group decreased significantly(p <0.05).(4)In experimental group,FBG,FINS and HOMA-IR decreased significantly(p <0.05),and FINS and HOMA-IR decreased significantly compared with control group(p <0.05),indicating that the improvement of insulin resistance in experimental group was more significant.There was no significant change in serum lipid level in experimental group,while HDL and LDL decreased in control group(p <0.05).(5)The control group has a slight decrease in FAI(p >0.05),while the experimental group has decreases in LH/FSH,T and FAI.The T level in experimental group decreased significantly(p <0.05),indicating that the improvement of high androgen in experimental group was more obvious.(6)In terms of liver and kidney function,there were no significant changes in liver and kidney function indexes,urinary microalbumin and ACR in the control group(p >0.05).The AST of experimental group decreased(p<0.05),but all of them were within the normal range.The remaining indexes had no significant change.(7)There were no serious adverse reactions in the two groups during the treatment,which showed high safety.Part 2(1)A total of 6 patients were enrolled in this study.After 12 weeks of treatment,the weight,BMI,waist-hip comparison and AMH levels of the patients were significantly decreased(p <0.05).HOMAIR decreased after treatment,indicating a slight improvement in insulin resistance(p >0.05).(2)All serum samples were tested for non-target metabolomics analysis.PCA,OPLS-DA and model validation revealed significant differences between the distribution of samples.A total of 110 differential metabolites were detected(p <0.05,VIP>1),mainly including amino acids,carbohydrates,inorganic oxides,lipids,organic acids and other components.A total of 9 differential metabolites were screened out identified by multivariate and univariate statistical analyses,including fatty acids such as free fatty acids,pyridines and alcohols.Potential biomarker screening and pathway enrichment analysis of these showed that differential metabolites were enriched in four metabolic pathways: fatty acid biosynthesis,linoleic acid metabolism,fatty acid elongation in mitochondria and fatty acid metabolism.Conclusion1.The treatment of quality high-protein diet combined with metformin can significantly improve menstrual disorder and hyperandrogenemia,improve insulin resistance and reduce T level in PCOS patients,without obvious adverse reactions,showing good efficacy and high safety.2.After the treatment of 12 weeks,the weight,muscle mass and body fat of the patients decreased obviously.The fat mass of extremities and trunk of the experimental group was significantly decreased,especially in both upper limbs and trunk,while the fat mass of the control group was mainly decreased in both lower limbs.3.The treatment of quality high-protein diet combined with metformin can improve insulin resistance and menstrual disorders by reducing the level of free fatty acids,which may be related to fatty acid biosynthesis,linoleic acid metabolism and other pathways,but further study is needed to expand the sample size. |
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