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IRCT20150815023617N6 IRCT 2022-06-22 Shahid Beheshti University of Medical Sciences The effects of synbiotic supplement containing Bacillus coagulans on women with polycystic ovarian syndrome. The effects of synbiotic supplement containing Bacillus coagulans on glycemic control, lipid profile, testosterone, systemic inflammation and anthropometric measurements in women with polycystic ovarian syndrome. 2022-06-22 anticipated 50 Complete https://irct.ir/trial/64042 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization of women, the Stratified Blocked Randomization method based on BMI, use of hormonal drugs that modulate the menstrual cycle and metformin will be used, Blinding description: In order to perform this research in a three blinded method, at the beginning of the study, the sachets containing synbiotic or placebo supplements are coded by the factory as A and B so that the lack of information of the researcher, statistical analyst and patients of the type of supplements received by each group is observed. . 3 Polycystic Ovarian Syndrome. Intervention 1: Intervention group: For 12 weeks, they will consume 1 sachet of synbiotic from Parsi Lact Co, Iran daily. Each 2 gram sachet contains 10 to the power of 10 CFU/g of Bacillus coagulans, 10 to the power of 10 CFU/g of Lactobacillus rhamnos, 10 to the power of 10 CFU/g of Lactobacillus helveticus, 500 mg of fructooligosaccharide and a 0.7% orange flavor. Intervention 2: Control group: For 12 weeks, they will consume 1 sachet of placebo from Parsi Lact Co, Iran daily. Each 2 gram sachet contains starch and a 0.7% orange flavor. Yes - There is a plan to make this available What will be shared: Only part of the data is shared, such as the original outcome. When: The start of the access period is 12 months after printing the results. To whom: It will be available for researchers working in academic and scientific institutions. Conditions: The documentation can only be used for more complete studies in this field. Where to obtain: Dr Golbon Sohrab Faculty member (assistant professor) at Faculty of Nutrition Sciences & Food Technology, Shaheed Beheshti University of Medical Sciences Email: golbonsohrab@sbmu.ac.ir How to obtain: The communication will be possible through the electronic mail given in the previous section. Comments:
public Golbon Sohrab
No. 7, West Hafezi Ave., Farahzadi Blvd., Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7483 golbonsohrab@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Golbon Sohrab
No. 7, West Hafezi Ave., Farahzadi Blvd., Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2207 7425 golbonsohrab@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Having polycystic ovary syndrome according to Rotterdam criteria At least 2 weeks after the diagnosis and treatment of PCOS Being in the age range of 18-45 years Being in the BMI range: 18.5-35 Willingness to cooperate 18 years 45 years Female Being pregnant Having liver disease, Kidney failure and heart failure, Infectious or inflammatory diseases, Thyroid disorders, Diabetes, Cancers, Hyperprolactinemia Take supplements or products containing synbiotics or probiotics in the past month Taking antibiotics in the last three months Consumption of corticosteroids or omega-3 E28.2 Polycystic ovarian syndrome Treatment - Drugs Placebo Intervention group: For 12 weeks, they will consume 1 sachet of synbiotic from Parsi Lact Co, Iran daily. Each 2 gram sachet contains 10 to the power of 10 CFU/g of Bacillus coagulans, 10 to the power of 10 CFU/g of Lactobacillus rhamnos, 10 to the power of 10 CFU/g of Lactobacillus helveticus, 500 mg of fructooligosaccharide and a 0.7% orange flavor. Control group: For 12 weeks, they will consume 1 sachet of placebo from Parsi Lact Co, Iran daily. Each 2 gram sachet contains starch and a 0.7% orange flavor. Fasting blood glucose (FBG). Timepoint: Measurement of fasting blood sugar at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption. Method of measurement: Enzymatic method. Serum Insulin. Timepoint: Measurement of serum insulin at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption. Method of measurement: Elisa method. Serum total testosterone. Timepoint: Measurement of serum total testosterone at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption. Method of measurement: Elisa method. HOMA-β: The homeostasis model assessment of pancreatic β-cell function. Timepoint: Measurement of HOMA-β at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption. Method of measurement: Calculating by formula: HOMA-β=360×Insulin (lnternational Unit/mililiter)/Fasting glucose (miligram/deciliter) − 63. HOMA-IR: Homeostatic model assessment of insulin resistance. Timepoint: Measurement of HOMA-IR at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption. Method of measurement: Calculating by formula: HOMA-IR = [FBG (miligram/deciliter)×Fasting Insulin (lnternational Unit/mililiter)]/405. QUICKI: The quantitative insulin-sensitivity check index. Timepoint: Measurement of QUICKI at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption. Method of measurement: Calculating by formula: QUICKI = 1/[log fasting insulin (lnternational Unit/mililiter)+log fasting glucose(miligram/deciliter)]. Serum triglyceride (TG). Timepoint: Measurement of serum triglyceride at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption. Method of measurement: Enzymatic method. Serum total cholesterol. Timepoint: Measurement of serum total cholesterol at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption. Method of measurement: Enzymatic method. Low density lipoprotein cholestrol (LDL-C). Timepoint: Measurement of low density lipoprotein cholestrol (LDL-C) at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption. Method of measurement: Enzymatic method. High density lipoprotein cholestrol (HDL-C). Timepoint: Measurement of high density lipoprotein cholestrol (HDL-C) at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption. Method of measurement: Enzymatic method. C reactive protein quantitive (CRP Quantitive). Timepoint: Measurement of C reactive protein quantitive (CRP Quantitive) at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption. Method of measurement: Elisa method. Weight. Timepoint: Measurement of weight at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption. Method of measurement: Body weight scale. Waist circumference. Timepoint: Measurement of waist circumference at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption. Method of measurement: Tape meter. Hip circumference. Timepoint: Measurement of hip circumference at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption. Method of measurement: Tape meter. Body mass index. Timepoint: Measurement of BMI at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption. Method of measurement: Calculating by formula: Weight in kilogram / the square of the height in centimeters. Shahid Beheshti University of Medical Sciences Approved 2022-02-21 Research Ethics Committees of National Nutrition & Food Technology Research Institute No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town. Tehran Tehran Iran (Islamic Republic of)