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