Polycystic Ovarian Syndrome. Polycystic ovarian syndrome
Conditions
Interventions
Intervention 1: Intervention group: High Performance Inulin group. With Degree of Polymerization equal or more than 22, with commercial name Frutafit® TEX, Sensus/Netherlands. The supplement will be
Sponsors
Esfahan University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: Patients between 18 to 40 years old BMI between 25 to 35 Kg/m2 Unwillingness to cooperate with the project Not intended to become pregnant
Exclusion criteria
Exclusion criteria: Current consumption (or during the previous 3 months) of oral contraceptive pills, hormone therapy, anti-diabetic or insulin sensitizing drugs, weight loss drugs, probiotic, synbiotic or prebiotic supplements, antibiotics, proton pomp inhibitors, multivitamin or mineral supplements or other nutritional supplements History of other endocrine disorders, including Thyroid disorders, Hyperprolactinemia, Cushing syndrome, Diabetes or Glucose Intolerance, and Androgenic disorders Pregnancy and lactation Smoking or alcohol consumption History of Gastrointestinal disorders, such as Inflammatory Bowel Diseases and Irritable Bowel Syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The score of hirsutism severity in modified Ferriman-Galway Scale. Timepoint: At the beginning of the study, at the end of the sixth week and at the end of the study. Method of measurement: modified Ferriman-Galway Scale.;Free Androgen Index. Timepoint: At the beginning of the study and at the end of the intervention. Method of measurement: Based on serum total Testosterone and serum SHBG.;Serum hs-CRP. Timepoint: At the beginning of the study and at the end of the intervention. Method of measurement: ELISA immunoassay kit.;Serum Endothelin-1. Timepoint: At the beginning of the study, and at the end of the study (end of the twelfth week). Method of measurement: ELISA immunoassay kit.;Serum Fasting Plasma Glucose. Timepoint: At the beginning of the study, and at the end of the study (end of the twelfth week). Method of measurement: Calorimetric assay.;Serum Fasting Insulin. Timepoint: At the beginning of the study, and at the end of the study (end of the twelfth week). Method of measurement: ELISA immunoassay kit.;Insulin resistance. Timepoint: At the beginning of the study, and at the end of the study (end of the twelfth week). Method of measurement: (Quantitative Insulin Sensitivity Check Index (QUICKI).;Insulin resistance. Timepoint: At the beginning of the study, and at the end of the study (end of the twelfth week). Method of measurement: Homeostatic Model Assessment Index (HOMA).;Serum Triglyceride level. Timepoint: At the beginning of the study, and at the end of the study (end of the twelfth week). Method of measurement: Calorimetric assay.;Serum Low-Density Lipoprotein (LDL-cholesterol). Timepoint: At the beginning of the study, and at the end of the study (end of the twelfth week). Method of measurement: Calorimetric assay.;Serum High-Density Lipoprotein (HDL-cholesterol). Timepoint: At the beginning of the study, and at the end of the study (end of the twelfth week). Method of measurement: Calorimetric assay.;Serum Total Cholesterol. Timepoint: At the begi | — |
Secondary
| Measure | Time frame |
|---|---|
| Weight. Timepoint: At the beginning of the study, at the end of the sixth week and at the end of the intervention. Method of measurement: Standard weight scale.;Systolic and Diastolic blood pressure. Timepoint: At the beginning of the study, at the end of the sixth week and at the end of the intervention. Method of measurement: Digital Sphygmomanometer.;Body Mass Index. Timepoint: At the beginning of the study, at the end of the sixth week and at the end of the intervention. Method of measurement: It will calculated by weight divided by height (in meters). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactRahele Ziaei
Esfahan University of Medical Sciences
Outcome results
None listed