Abstract Background: This trial aims to investigate the effect of 12 weeks of 10 mg/day astaxanthin (ASX) administration compared with the control group on insulin sensitivity, lipid profile, circulating MDA levels, severity of hirsutism, and depression in women with Polycystic Ovary Syndrome (PCOS).
Methods: This manuscript will outline the design, methodology, and potential clinical implications of ASX supplementation in eligible women with PCOS and a body mass index of 25-35 kg/m2, who are referred to the gynecologist clinic in Isfahan, Iran, during 2024-2025.
Discussion: This study is one of the first attempts to assess the clinical efficacy of astaxanthin as an auxiliary treatment in PCOS patients, and will provide more evidence in this area.
Trial registration number: Iran Clinical Trials (IRCT) website. (IRCT20231001059573N1)
Age 18 - 45 years
Clinical diagnosis of polycystic ovary syndrome
Have a body mass index of 25-35 kg/m 2
Absence of pregnancy and breastfeeding
Consuming less than 80% of the total administered ASX supplements
Ongoing pregnancy
Changing their usual diet or eating habits or level of physical activity
Presence of Skin or digestive allergy symptoms or any desired complications by intake of ASX supplementation
Parallel
Subjects in the intervention group will receive one capsule containing 10 mg Astaper day made by the "Zyest Technology Tarawat Zendig" institute in Iran. The dosage of ASX is determined based on the s
DrugSubjects in the intervention group will receive one capsule containing 10 mg Astaper day made by the "Zyest Technology Tarawat Zendig" institute in Iran. The dosage of ASX is determined based on the s
Placebo
DrugThe placebo group will take one capsule containing corn starch in a wrapped and covered form and the appearance of ASX supplementation (blinding).
Blood pressure measurement
To measure blood pressure, patients were asked to rest for 10 minutes, then the measurement was done using a mercury sphygmomanometer (Riester, Germany). The blood pressure of each person will be measured twice with a time interval of 10 minutes, in a sitting position, from the right arm and at the level of the heart. The average of these two measurements was considered as the patient's blood pressure. Before taking blood pressure, patients will be asked about smoking or drinking coffee in the previous 2 hours
Evaluation of the severity of hirsutism
To assess the 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 to the modified Ferriman-Gallwey (mFG) scoring system. In this system, each body sit will be visually scored on a scale of 0 to 4, and the maximum score of each participant could be 16. The final score of 0 to 3 will be measured as non-hirsutism, 4 to 7 will be considered mild hirsutism, and 8 Up to 11 and 12 to 16 will reflect moderate hirsutism and severe hirsutism, respectively. Subjects will be asked to not use any removing hair methods during the study.
Evaluation of biochemical indicators
On days zero (before the start of the intervention) and day 80 (the end of the intervention), 10 cc of blood is taken from the patient in the morning and collected in a plastic tube. It is left with 3,600 revolutions for 3-4 minutes and poured into microtubes containing 0.5 ml. The samples are stored in a freezer at -70°C. To reduce the measurement error, all samplings are done at 8-10 in the morning and in the fasting state. Blood samples taken from patients at the beginning and end of the study are centrifuged for 10 minutes at 300 rpm to separate their serum. Serum values of lipid profile (triglyceride (TG) level, total cholesterol, Low-density lipoprotein cholesterol (LDL-c), and High-density lipoprotein cholesterol (HDL-c) serum) are measured by enzymatic colorimetric method. To measure serum cholesterol, cholesteryl ester enzymes are then added to the solution, and cholesterol oxidase is finally converted into cholesterol-4-en-3-one H₂O₂ and the cholesterol concentration of the
Physical Activity Assessment Questionnaire
The physical activity evaluation of the participants will be recorded by the short form of the International Physical Activity Questionnaire (IPAQ) 4 times (at the baseline, 4-week, 8-week, and the end of the study)(22). To obtain the overall physical activity score based on MET-minutes/week, the score obtained from 3 activity categories including walking, moderate physical activity, and vigorous physical activity will be recorded.
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