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IRCT20200608047697N1 IRCT 2020-08-01 Kermanshah University of Medical Sciences Evaluation of effects of cardamom supplementation among obese women with polycystic ovary syndrome Effects of cardamom supplementation on antheropometric indices, cardiometabolic status, obesity and diabetes gene expression among obese women with polycystic ovary syndrome 2020-08-21 anticipated 140 Complete https://irct.ir/trial/48748 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Using the draw method the names of the participants will be written on the separate papers and will be placed inside a container. Then the names of the participants will be withdrawn randomly. The first 70 names will be placed in the intervention group and the rest in the control group, Blinding description: This clinical trial will be double blind, with the researcher and participants not aware of the allocation of groups, and the supplements appearance will be similar in both groups. The supplements will be encode by manufacturer before delivery. 3 Poly-cystic Ovarian Syndrome. Intervention 1: Intervention group: The intervention will be performed with weight loss diet (reduction of 300-500 kcal per day of energy required based on the adjusted ideal body weight) and three 1 gram capsules containing cardamom daily (Karen Company, Canada, representative in Iran) three times a day with the main meals. Intervention 2: Control group: weight loss diet (reduction of 300-500 kcal per day of energy required based on the adjusted ideal body weight) and three 1 gram capsules containing starch (placebo) (Karen Company, Canada, representative in Iran) will be received three times a day with the main meals. Yes - There is a plan to make this available What will be shared: Data collected for the primary outcomes will be shared. When: After publication of the results in valid Journals To whom: The data will only be available for people working in academic institutions. Conditions: For Meta- analysis studies Where to obtain: Shima Moradi- Shool of nutritional Sciences and Food Technology Shima.Moradi@kums.ac.ir How to obtain: By email Shima.Moradi@kums.ac.ir Comments:
public Shima Moradi
Isar Square, next to Farabi Hospital, School of Nutrition and Food Sciences
Kermanshah Iran (Islamic Republic of) 6719851351 +98 83 3710 2015 Shima.Moradi@kums.ac.ir Kermanshah University of Medical Sciences scientific Dr. Yahya Pasdar
Isar Square, next to Farabi Hospital, School of Nutrition and Food Sciences
Kermanshah Iran (Islamic Republic of) 6719851351 +98 83 3826 2005 Yahya.Pasdar@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) Diagnosis of polycystic ovary syndrome based on Rotterdam criteria for at least two of the following factors: 1. Oligomnorrhea or amenorrhea. 2. Biochemical or clinical symptoms increased levels of androgens in the blood.3- Having polycystic ovaries in ultrasound Women with age range between 18-45 year Body mass index more than 30 kg/m2 Voluntary participation in the project 18 years 45 years Female Pregnancy and lactation Illnesses such as autoimmune, gastrointestinal, liver, thyroid and unstable cardiovascular diseases, severe depression, mental diseases, severe respiratory diseases (asthma and chronic bronchitis) Take any vitamin and mineral supplements Allergies to cardamom, cardamom tea and cardamom products E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Drugs Intervention group: The intervention will be performed with weight loss diet (reduction of 300-500 kcal per day of energy required based on the adjusted ideal body weight) and three 1 gram capsules containing cardamom daily (Karen Company, Canada, representative in Iran) three times a day with the main meals. Control group: weight loss diet (reduction of 300-500 kcal per day of energy required based on the adjusted ideal body weight) and three 1 gram capsules containing starch (placebo) (Karen Company, Canada, representative in Iran) will be received three times a day with the main meals. Reducing of weight among obese women with polycystic ovary syndrome. Timepoint: Measurement of weight before intervention and 12 week after intervention. Method of measurement: Weight measurement will be performed using the Inbody 770 with minimal clothing. Reducing of waist circumference among obese women with polycystic ovary syndrome. Timepoint: Measurement of waist circumference before intervention and 12 week after intervention. Method of measurement: Waist circumference measurement will be performed using a flexible tape between the last rib and the top of the iliac crest in exhalation. Improvement of blood pressure among obese women with polycystic ovary syndrome. Timepoint: Measurement of blood pressure before intervention and 12 week after intervention. Method of measurement: Blood pressure will be measured using a digital arm sphygmomanometer. Improvement of insulin level. Timepoint: Measurement of insulin level before intervention and 12 week after intervention. Method of measurement: Insulin level will be measured by ELISA method. Improvement of fasting blood sugar. Timepoint: Measurement of fasting blood sugar before intervention and 12 week after intervention. Method of measurement: Fasting blood sugar was measured by Glucose oxidase method. Improvement of lipid profile. Timepoint: Measurement of lipid profile before intervention and 12 week after intervention. Method of measurement: Lipid profile will be measured by enzymatic kits (Pars Azmoon, Iran). Improvement of inflammatory status. Timepoint: Measurement of C- reactive protein before intervention and 12 week after intervention. Method of measurement: Measurement of C- reactive protein will be performed by Highly sensitive CRP assay method. Reducing of obesity and diabetes gene expression. Timepoint: Measurement of obesity and diabetes gene expression before intervention and 12 week after intervention. Method of measurement: The expression of obesity and diabetes genes will be determined by Real Time PCR and specific primers designed with valid software. Kermanshah University of Medical Sciences Approved 2020-07-13 Ethics Committee of Kermanshah University of Medical Sciences Building No. 2, Research Council of Kermanshah University of Medical Sciences (KUMS), Shahid Beheshti Boulevard, Kermanshah, Iran. Kermanshah Kermanshah Iran (Islamic Republic of)