Polycystic Ovary Syndrome. Polycystic ovarian syndrome
Conditions
Interventions
Intervention group: Astaxanthin.
Sponsors
Esfahan University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Nafiseh Shokri
Esfahan University of Medical Sciences
Outcome results
None listed