]>
IRCT20101101005062N11 IRCT 2020-11-10 Esfahan University of Medical Sciences The effect of Inulin-type Fructans, in treatment of Polycystic Ovary Syndrome The Effect of Inulin-type Fructans, with different degrees of polymerization, on metabolic parameters, hormonal status, inflammatory markers, oxidative stress, and endothelial dysfunction, in women with Polycystic Ovary Syndrome: A Randomized, Double-blind, Controlled, Clinical Trial 2020-10-22 anticipated 75 Complete https://irct.ir/trial/48088 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: The patients will be divided into three groups: High Performance Inulin- Oligofructose-enriched Inulin- Placebo, Randomization description: Randomization will be done by Permuted Block Randomization, via the website, https://www.sealedenvelope.com/simple-randomiser/v1/lists. Each block has capacity for four subjects. After that, subjects will be randomly assigned to treatment or placebo groups, within each block. Random assignment will be done using a random chain, which will be extracted from the site, Blinding description: Two ype of Inulin supplements and palcebo will be given to patients in similar packs. Both patients and the researcher are not aware of being in intervention or placebo group. Inulin supplements and placebo are relatively identical, in terms of color, taste and solubility. N/A Polycystic Ovarian Syndrome. 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 given to patients in 10 grams packs. It should be consumed by dissolving in water or yogurt, with main meals. Intervention 2: Intervention group: Oligofructose-enriched inulin, with average Degree of Polymerization between 8 to 13, with commercial name Frutafit® IQ, Sensus/Netherlands. The supplement will be given to patients in 10 grams packs. It should be consumed by dissolving in water or yogurt, with main meals. Intervention 3: Control group: Maltodextrin powder, 10 grams per day. The placebo will be given to patients in 10 grams packs. It should be consumed by dissolving in water or yogurt, with main meals. Yes - There is a plan to make this available What will be shared: Major parts of data will be available for the population. When: 12 months after publishing the results. To whom: Available for academic researchers, who work in academic and scientific institutions. Conditions: For conducting similar projects. Where to obtain: Dr. Reza Ghiasvand ghiasvand@hlth.mui.ac.ir How to obtain: The data will be send one month after receiving the request. Comments:
public Rahele Ziaei
School of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 8487 r.ziaei92@gmail.com Esfahan University of Medical Sciences scientific Reza Ghiasvand
School of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 8487 ghiasvand@hlth.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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 18 years 40 years Female 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 E28.2 Polycystic ovarian syndrome Treatment - Other Treatment - Other Placebo 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 given to patients in 10 grams packs. It should be consumed by dissolving in water or yogurt, with main meals. Intervention group: Oligofructose-enriched inulin, with average Degree of Polymerization between 8 to 13, with commercial name Frutafit® IQ, Sensus/Netherlands. The supplement will be given to patients in 10 grams packs. It should be consumed by dissolving in water or yogurt, with main meals. Control group: Maltodextrin powder, 10 grams per day. The placebo will be given to patients in 10 grams packs. It should be consumed by dissolving in water or yogurt, with main meals. 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 beginning of the study, and at the end of the study (end of the twelfth week). Method of measurement: Calorimetric assay. Dietary intakes. Timepoint: At the beginning of the study, at the end of the sixth week, and at the end of the intervention. Method of measurement: Three-days Food Record. Serum Nitric Oxide level. 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 Sex-Hormone Binding Globulin (SHBG). 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 Total Testosterone. 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. Mood status score. Timepoint: At the beginning of the study, and at the end of the study (end of the twelfth week). Method of measurement: DASS-21 Questionnaire. Quality of life score. Timepoint: At the beginning of the study, and at the end of the study (end of the twelfth week). Method of measurement: PCOS quality-of-life questionnaire (PCOSQ). 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). Esfahan University of Medical Sciences Approved 2020-10-20 Ethics committee of Isfahan University of Medical Sciences School of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Hezarjerib St, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)