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IRCT20190407043193N1 IRCT 2019-06-30 Esfahan University of Medical Sciences effect of canola and olive oils consumption in polycystic ovary syndrome Study of the effect of canola and olive oils consumption on anthropometric, inflammatory, glycemic and hormonal indices, lipid profiles, grade of fatty liver and mood disorder score in patients with polycystic ovary syndrome 2018-10-22 anticipated 90 Complete https://irct.ir/trial/38684 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The samples were classified using randomized block splitting and divided into three groups using random numbers table, Blinding description: In this study, the patients were randomly divided into three groups who were informed about entering the study and were not aware of the type of intervention received. On the other hand, the researcher who does all the information and measurements is also unaware of the type of intervention that each patient receives. A collaborator physician in the study was also blinded to this study. 2-3 Polycystic ovary syndrome. Intervention 1: Intervention group: 25 grams of olive oil. Intervention 2: Intervention group: 25 grams of canola oil. Intervention 3: Control group: 25 grams of sunflower oil. Yes - There is a plan to make this available What will be shared: Proposals and consent form and published article from the study When: Getting Started October 1399 To whom: Academic Institutions Conditions: To give students access to their dissertations Where to obtain: You can call 09134118836 for help How to obtain: After doing the research and publishing the paper, it will provide you with the documentation. Comments:
public Maryam Yahay
Hezarjrib ave, Isfahan university of medical science. faculty of nutrition.
Esfahan Iran (Islamic Republic of) 8156685691 +98 31 3662 4711 maryam.yahay@gmail.com Esfahan University of Medical Sciences scientific Maryam Yahay
Hezarjrib ave, Isfahan university of medical science. faculty of nutrition.
Esfahan Iran (Islamic Republic of) 8156685691 +98 31 3662 4711 maryam.yahay@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) The definitive diagnosis of PCOS based on diagnostic criteria (Rotterdam3) by the physician The absence of other endocrine disorders or the conditions that lead to some or most of the clinical manifestations and disorders associated with PCOS (such as congenital or non-classic adrenal hyperplasia, Cushing's syndrome, androgens secreting tumors, drugs induced hyperandrogenism, idiopathic hyperandrogenism, hirsutism Idiopathic, thyroid dysfunction, hyperprolactinemia, pregnancy, lactation and menopause) Non-use of any drug and / or surgical treatment for the clinical symptoms and disorders associated with PCOS other than OCP (such as spironolactone, finasteride, isotretinoin, letrozole, clomiphene, gonadotropins, metformin, cyproterone, rosiglitazone, pioglitazone, ovarian laparoscopic surgery, and Auxiliary reproductive technology) Absence of any severe or significant systemic disease requiring treatment such as any cancer; digestive, liver or endocrine disorders (such as celiac disease, Crohn's disease, ulcerative colitis), diabetes mellitus, hyperparathyroidism, hypercalcemia, or hyperphosphatemia); cardiovascular disorders (e.g. Uncontrolled hypertension or history of myocardial infarction); kidney disorders (such as renal failure, nephrotic syndrome); blood coagulation disorders (eg thalassemia, hemophilia); neurological disorders (such as epilepsy) or reproductive disorders associated with PCOS Ask a doctor or a patient Not taking any of these items: tobacco; alcohol; anti-estrogens (such as tamoxifen and raloxifene); oral or injectable corticosteroids (such as prednisone, prednisolone, dexamethasone, triamcinolone, hydrocortisone or betamethasone); lack of omega-3 supplementation Chains and long chains); effective drugs for insulin resistance such as metformin and sitagliptin Non-consumption of any canola and olive oil in the last 6 months as the main consumer oil Lack of any allergy, intolerance or harmful drug reaction to the supplementation of the studied oils Being in the age range of 18-45 years (people are not better off at the age of growth and menopause) Being in the BMI range above 25 and less than 40 Ability to understand the goals of the study and provide informed written consent The desire to participate in the study Weight constant over the past 6 months (self report) Lack of Pregnancy and Breastfeeding 18 years 45 years Female The onset of a dose or any change in dosage in the above drugs or the change in the type or dose of OCP consumed during the study period Getting pregnant during the study period Incidence of severe side effects or signs of poisoning with supplements used during the study period Failure to adhere to the study protocol The acceptance of less than 80% of the intervention (consumption of less than 80% of the total intervention oil that should be consumed during the 10-week intervention period will be considered as a low admission) E28.2 Polycystic ovarian syndrome Treatment - Other Treatment - Other Treatment - Other Intervention group: 25 grams of olive oil Intervention group: 25 grams of canola oil Control group: 25 grams of sunflower oil Lipid profile. Timepoint: At the beginning of the study, 5 weeks after the intervention and the end of the study. Method of measurement: Spectrophotometric method. Anthropometric Indicators. Timepoint: At the beginning of the study, 5 weeks after the intervention and the end of the study. Method of measurement: Measurements with biometric impedance analysis (BIA) and meters. Fatty liver grade. Timepoint: At the beginning of the study, 5 weeks after the intervention and the end of the study. Method of measurement: sonography. Mood disorder score. Timepoint: At the beginning of the study, 5 weeks after the intervention and the end of the study. Method of measurement: DASS-21 questionnaire. Inflammatory Indicators. Timepoint: At the beginning of the study, 5 weeks after the intervention and the end of the study. Method of measurement: ELISA. Clinical signs including hirsutism and the interval between menstruation. Timepoint: At the beginning of the study, 5 weeks after the intervention and the end of the study. Method of measurement: MFGS questionnaire And the question of the patient. Blood pressure. Timepoint: At the beginning of the study, 5 weeks after the intervention and the end of the study. Method of measurement: Mercury barometric. Esfahan University of Medical Sciences Approved 2019-11-17 Ethics Committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences. Hazar Jarib Street isfahan Isfehan Iran (Islamic Republic of)