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IRCT20230615058489N1 IRCT 2023-06-25 Islamic Azad University the effect of low free sugar diet in patients with polycystic ovary syndrome - The effect of low free sugar diet on anthropometric parameters, lipid profile and glycemic control in women with polycystic ovarian syndrome 2023-07-06 anticipated 74 Complete https://irct.ir/trial/70811 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to randomly assign patients to two groups, stratified blocked randomization method is used based on BMI (overweight or obese). The size of the blocks is 4 blocks, two allocations to the intervention group (A) and two allocations to the control group (B) are considered. 6 permutations including AABB, ABAB, BBAA, BABA, ABBA, BAAB will be created. Finally, these permutations will be used for both BMI blocks. N/A Polycystic Ovary syndrome. Intervention 1: Intervention group: For 12 weeks, the low free sugar diet (less than 3% of calories are from free sugar) is provided along with the recommendations of a healthy diet and physical activity, and in order to follow the program, a food record is recorded every 2 weeks through A phone call is made. Intervention 2: Control group: food and physical activity recommendations / 12 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Asal Ataie Jafari
Research and Science Branch, Daneshgah Blvd, Simun Bulivar Blvd, Tehran
Tehran Iran (Islamic Republic of) 1477893855 +98 21 4486 5179 asal_ataie2003@yahoo.com Islamic Azad University scientific Hajar Gholamshahi
Unit 212, Dastwara Residential Complex, No. 185, Dastwara Blvd., after Godarzi Alley, South Aliabad, Tehran
Tehran Iran (Islamic Republic of) 1838871936 +98 21 5531 2098 hajar.gholamshahi@gmail.com Islamic Azad University Iran (Islamic Republic of) willingness to participate in research Age 18-45 years BMI> 25 Having polycystic ovarian syndrom based on the diagnosis of gynecologist ( According to Rotterdom criteria) Less than 6 months have passed since diagnosis People who get more than 10% of their calories from free sugars Absence of other diseases and chronic and acute disorders of women such as uterine and ovarian cancers Not suffering from liver diseases, suffering from kidney failure and heart failure, suffering from infectious or inflammatory diseases, suffering from thyroid gland disorders, diabetes, types of cancer, hyperprolactinemia Not pregnant or breastfeeding Non-adherence to special diets or weight loss diets in the last three months Not using hormonal drugs, corticosteroids, omega-3 and spironolactone 18 years 45 years Female Unwillingness to continue cooperation Failure to follow the intervention diet for more than 2 days Starting a new diet other than the nutritional recommendations provided in the control group pregnancy Changing the medication regimen, physical activity during the intervention period E28.2 Polycystic ovarian syndrome Treatment - Other Treatment - Other Intervention group: For 12 weeks, the low free sugar diet (less than 3% of calories are from free sugar) is provided along with the recommendations of a healthy diet and physical activity, and in order to follow the program, a food record is recorded every 2 weeks through A phone call is made. Control group: food and physical activity recommendations / 12 weeks Fasting Blood Glucose (FBG). Timepoint: Beggining and after 12 weeks. Method of measurement: Enzymatic method. Serum insulin. Timepoint: Beggining and after 12 weeks. Method of measurement: ELISA. HOMA-IR. Timepoint: Beggining and after 12 weeks. Method of measurement: Calculate. QUICKI. Timepoint: Beggining and after 12 weeks. Method of measurement: calculate. Serum triglycerides. Timepoint: Beggining and after 12 weeks. Method of measurement: Enzymatic Method. Total serum cholesterol. Timepoint: Beggining and after 12 weeks. Method of measurement: Enzymatic Method. Serum LDL-C. Timepoint: Beggining and after 12 weeks. Method of measurement: Enzymatic Method. Serum HDL-C. Timepoint: Beginning and after 12 weeks. Method of measurement: Enzymatic Method. Weight. Timepoint: Beginning and after 12 weeks. Method of measurement: Scales. Body Mass Index. Timepoint: Beginning and after 12 weeks. Method of measurement: Calculate. Waist to hip ratio. Timepoint: Beginning and after 12 weeks. Method of measurement: Calculate. Islamic Azad University Approved 2023-06-10 Research ethic committee Islamic Azad University_ Science and research Branch Science and Research Branch, Daneshgah Blvd,Simon Bulivar Blvd, Tehran Tehran Tehran Iran (Islamic Republic of)