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IRCT20100408003664N19 IRCT 2018-03-18 Tabriz University of Medical Sciences Effect of synbiotic supplementation in patients with polycystic ovary syndrome Study of the Effect of synbiotic supplementation on metabolic status ، serum apelin levels and anthropometric indexes in patients with polycystic ovary syndrome 2018-03-21 anticipated 68 Complete https://irct.ir/trial/28155 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Samples were selected using available methods and randomly assigned random blocks of 4 volumes to the study groups.A random sequence is generated using the STATA14 software.During the random assignment, individuals in the groups will be classified according to age and BMI variables, Blinding description: Double blind practices: Trials that are planned in a way that neither the studied subjects nor the observers (researchers) know who the group is. N/A polycystic ovary syndrome. Intervention 1: Intervention group: En Interventions 1: 500mg capsules of synbiotic 1 per day for 8 weeks Interventions ,, Half an hour after lunch, the product of Biostimiran Company. Intervention 2: Control group: Placebo: 500 mg capsule 1 per day for 8 weeks, half an hour after lunch. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Because the research project has not yet begin.
public Sima Darvishi
Tabriz University of Medical Science,Nutrition Faculty,Attar Neyshabori,Golgasht Street
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 7581 simaadarvishi@gmail.com Tabriz University of Medical Sciences scientific Sima Darvishi
Tabriz University of Medical Sience,Nutrition Faculty, Attar Neyshabori,Golgasht street,Tabriz,Iran
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 7580 simaadarvishi@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) • Women with PCOS aged 20-40 years • Diagnosis of PCOS in patients by Gynecologist and according to Rotterdam Standard 2003• The BMI range is between 40-25 m ^ 2/ kg 20 years 44 years Female • History of thyroid disorders, hyperprolactinemia, Cushing's syndrome, liver and kidney disease, cardiovascular disease, digestive diseases (food allergies, celiac disease, irritable bowel disease), high blood pressure and diabetes. Diagnosis of non-disease By asking the patient, using the existing tests and under the supervision of the doctor will be done. • Pregnancy and breastfeeding • Consumers of anti-obesity drugs and blood lipid lowering drugs, anticoagulants and glucocorticoids • Using a weight loss diet • smoking • Athlete or regular exercise • Sensitivity to synbiotic and probiotic capsules • Antibiotic use a month ago • Use of any dietary supplements in the last 2 months or during the study • Receiving probiotics, perebiotic, synbiotics during the last three months and during the study • Regular consumption of probiotic products E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Drugs Intervention group: En Interventions 1: 500mg capsules of synbiotic 1 per day for 8 weeks Interventions ,, Half an hour after lunch, the product of Biostimiran Company Control group: Placebo: 500 mg capsule 1 per day for 8 weeks, half an hour after lunch Fasting blood sugar. Timepoint: Begining and end of the intervention. Method of measurement: Analysing With Spectrophotometer. Level of Serum Insulin. Timepoint: Begining and end of the intervention. Method of measurement: Analysing with ELISA. HOMA-IR. Timepoint: Begining and end of the intervention. Method of measurement: Calculated According to The Formula. Total Cholestrol. Timepoint: Begining and end of the intervention. Method of measurement: Analysing With Spectrophotometer. HDL-C. Timepoint: Begining and end of the intervention. Method of measurement: Analysing With Spectrophotometer. LDL-C. Timepoint: Begining and end of the intervention. Method of measurement: Calculated According to The Friedewald Formula. TG. Timepoint: Begining and end of the intervention. Method of measurement: Analysing With Spectrophotometer. Apelin. Timepoint: Beginning and end of intervention. Method of measurement: Analysing With ELISA. Anthropometric indexes. Timepoint: Beginning and end of intervention. Method of measurement: Measuring with scales and meters. Tabriz University of Medical Sciences Approved 2018-02-24 Ethics committee of Tabriz University of Medical Science Tabriz University of Medical Science,Nutrition Faculty,Attar Neyshabori,Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)