]>
IRCT20231001059573N1 IRCT 2023-10-10 Esfahan University of Medical Sciences Efeect of Astaxanthin supplementation in women with Polycystic ovary syndrome (PCOs) Effect of Astaxanthin supplementation on the insulin sensivity, lipid profile, and clinical symptoms in women with PCOS: A randomized clinical study 2023-09-23 anticipated 44 Complete https://irct.ir/trial/72890 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly divided into 2 groups to receive astaxanthin supplement or placebo using the Permuted Block Randomization method. In this method, for selection of block size, we choose the block size 4 for this study (step1). For formation of blocks, participants are grouped into sets of four (step 2). For randomization within blocks within each block, randomization is performed using random number table. The key is that the treatment assignments within each block are randomly allocated (step 3). For balanced allocation, after randomizing the participants within a block, the number of participants assigned to each treatment group should be equal or as close to equal as possible (step 4). For the last step, steps 3 and 4 are repeated for each block of participants until all participants have been assigned to a treatment group, Blinding description: In this study, the person who performs the blood test, the person who prescribes the supplements and participants do not know about the division of people into two drug and placebo groups. In this randomised trial, the person who analyzes the data (statistician) will generate allocation sequence, and assign participants to interventions randomly. Since the astaxanthin supplement and placebo are completely similar in terms of color and shape, patients are also not aware of this division. All baseline assessments will be undertaken prior to randomization and some assessments will be undertaken blinded for group allocation. All incoming data, including questionnaires and laboratory tests are collected by expert investigators in considered data sheets, and reviewed by the trial coordinator at the the Ethics Committee of Isfahan University of Medical Science to promote data quality. Both participants in AST and placebo groups are coded by the pharmaceutical company (code A and B). So, the investigators and participants will not be informed about allocation and the cods will be concealed until end of study. N/A Polycystic Ovary Syndrome. Intervention group: Astaxanthin. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Dr. Nafiseh Shokri
Hezarjareeb street
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 nafiseh.shokri@yahoo.com Esfahan University of Medical Sciences scientific Dr. Nafiseh Shokri
Hezarjareeb street
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 nafiseh.shokri@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) PCOS diagnosis according to Rotterdam 2003 criteria Have a body mass index of 25-35 kg/m 2 Absence of pregnancy and breastfeeding No intake of medicine Not willing to get pregnant during the study 18 years 45 years Female Ongoing pregnancy Changing their usual diet or eating habits or level of physical activity Presence of Skin or digestive allergy symptoms or any complications by intake of Astaxanthin supplementation Smoking or alcohol consumption E28.2 Polycystic ovarian syndrome Treatment - Other Intervention group: Astaxanthin Effect of 10 mg/day Astaxanthin supplementation for 12 weeks on severity of hirsutism in women with PCOS. Timepoint: At the baseline, and the end of the study. Method of measurement: To assess severity of hirsutism, the amount of total body hair in nine sits (upper lip, chin, chest, upper and lower abdomen, thigh, upper and lower back, and upper arm) will be evaluated according the modified Ferriman–Gallwey (mFG) scoring system. In this system, each individual body sit will be visually scored on a scale of 0 to 4, and the maximum score of each participants could be 16. The final score of 0 to 3 will be measured non-hirsutism, 4 to 7 will be considered mild hirsutism, and 8 Up to 11 and 12 to 16 will be reflected moderate hirsutism and severe hirsutism, respectively. Subjects will be asked to not use any removing hair methods during the study. Effect of 10 mg/day Astaxanthin supplementation for 12 weeks on circulating Malondialdehyde levels in women with PCOS. Timepoint: At the baseline, and the end of the study. Method of measurement: Serum Malondialdehyde (MDA) values will be measured by the TBARS method (Arsam Far Biot Company kit) and with a spectrophotometer or fluorimeter. Efffect of 10 mg/day Astaxanthin administration for 12 weeks on insulin sensitivity in women with PCOS. Timepoint: At the baseline, and the end of the study. Method of measurement: To measure the serum glucose level, it will be converted to glucuronic acid by the activity of glucose oxidase, and the glucose concentration will be calculated using the quinonimine indicator. Fasting insulin will be measured by enzyme immunoassay methods. HOMA-IR index will be used to evaluate insulin resistance. To calculate the HOMA-IR index, fasting insulin (U/mlμ) and fasting blood glucose (nmol) will be used: HOMA-IR = fasting insulin (μU/L) x fasting glucose (nmol/L)/22.5. Serum Malondialdehyde (MDA) values will be measured by the TBARS method (Arsam Far Biot Company kit) and with a spectrophotometer or fluorimeter. Effect of 10 mg/day AST administration for 12 weeks on lipid profile in women with PCOS. Timepoint: At the baseline, and the end of the study. Method of measurement: Serum values of lipid profile (triglyceride, total cholesterol, LDL-c, HDL-c, cholesterol) are measured by enzymatic colorimetric methods. Lipase enzyme is used to measure TG, which converts TG into glycerol and fatty acid. Isfahan university of medical science Approved 2023-09-21 Ethics Committee of Isfahan University of Medical Science Hezarjareeb street Isfahan Isfehan Iran (Islamic Republic of)