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)
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Blood pressure measurement
Timeframe: From enrollment to the end of treatment at 8 weeks
Evaluation of the severity of hirsutism
Timeframe: From enrollment to the end of treatment at 8 weeks
Evaluation of biochemical indicators
Timeframe: From enrollment to the end of treatment at 8 weeks
Physical Activity Assessment Questionnaire
Timeframe: 4 times (at the baseline, 4-week, 8-week, and the end of the study)
Dietary intake assessment
Timeframe: at the baseline, 4-week, 8-week, and the end of the study)