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IRCT20191109045383N1 IRCT 2019-11-16 Esfahan University of Medical Sciences The effect of pomegranate juice concentrate in women with polycystic ovary syndrome The Effect Of Concentrated Pomegranate Juice On Depression score , Insulin Resistance(HOMA-IR) , oxidative And Antioxidant Markers (TAC , MDA) In Women With Polycystic Ovary Syndrome(PCOS) 2018-04-14 anticipated 44 Complete https://irct.ir/trial/43573 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Other design features: In this study, all individuals are divided into two groups: the first group receives the intervention and the second group is the control group that receives no intervention, Randomization description: First, we select all individuals using available sampling method and after describing the aims and methods of the study, if they wish to participate in the study, we randomly divided them into two groups of Concentrated pomegranate juice and control. N/A Polycystic Ovary Syndrome. Intervention 1: Intervention group: 45 ml Concentrated Pomegranate Juice for 8 weeks with 180 cc water, in the afternoon, Takeda factory of East Azarbaijan . Intervention 2: Control group: Does not receive any intervention. Yes - There is a plan to make this available What will be shared: clinical measurements as word file can be shared for other researchers When: the main data are available one year after pulication To whom: data are available for all clinicians especially RDNs. Conditions: data users had not allowed to analyze this data for drug industries. Where to obtain: mail to this address: maryamabedinii93@gmail.com How to obtain: just mail to this address and request with IRCT-related code: maryamabedinii93@gmail.com Comments:
public Maryam Abedini
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran
Esfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 1378 maryamabedinii93@gmail.com Esfahan University of Medical Sciences scientific Maryam Abedini
Faculty of Nutrition, Isfahan University of Medical Sciences, Hezar Jarib Ave, Isfahan, Iran
Esfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 1378 maryamabedinii93@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) 18≤Age≤40 BMI ≥ 25 Being single Not having acute and chronic diseases such as: cardiovascular disease, kidney, liver, diabetes, hypothyroidism, hyperthyroidism, asthma, neoplastic, hyperprolactinemia, malabsorption disorders, hypertension, dyslipidemia, (new or during 6 months). No Depression Not following a specific diet. Not following a specific exercise program. Non-use of drugs such as contraceptive pills (Oral contraceptive pill), hormonal drugs, anti-diabetic drugs, anti-obesity drugs, antioxidant supplements and multivitamin minerals, blood lipid lowering drugs. Not smoking Not allergic to pomegranate and its products. Not consuming pomegranates and pomegranate-containing products at least 2 months before starting the study 18 years 40 years Female Pregnancy Not consuming Concentrated Pomegranate Juice completely Not willing to continue participating in the study Treatment - Other Other Intervention group: 45 ml Concentrated Pomegranate Juice for 8 weeks with 180 cc water, in the afternoon, Takeda factory of East Azarbaijan . Control group: Does not receive any intervention. Evaluation of malondialdehyde in women with polycystic ovary syndrome. Timepoint: Baseline and 8 weeks after starting the study. Method of measurement: Measurement of serum malondialdehyde by calorimetric method using kiazist kit. Evaluation of total antioxidant capacity in women with polycystic ovary syndrome. Timepoint: Baseline and 8 weeks after starting the study. Method of measurement: Measurement of serum total antioxidant capacity by cupric reducing antioxidant capacity (CUPRAC) method using kiazist kit. Evaluation of insulin resistance in women with polycystic ovary syndrome. Timepoint: Baseline and 8 weeks after starting the study. Method of measurement: Measurement of Insulin Resistance Using Formula (fasting plasma glucose (mMol/L) × insulin (µIU/mL))/22.5. The levels of serum insulin will be determined using ELISA kit (AccuBind, Monobind Inc., USA) and fasting blood sugar will be measured by enzymatic photometric method using standard kits (Pars Azmun, Tehran, Iran). Depression score. Timepoint: Baseline and 8 weeks after starting the study. Method of measurement: Depression Anxiety Stress Scale-21 (DASS-21) questionnaire. Esfahan University of Medical Sciences Approved 2018-03-04 Ethics committee of Isfahan University of Medical Sciences Faculty of Nutrition, Isfahan University of Medical Sciences, Hezar Jarib Ave., Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)