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The Effectiveness of Astaxanthin Supplementation on the Clinical Symptoms and Cardio-metabolic Profile in Women with Polycystic Ovary Syndrome

RecruitingPhase 1Ages 18 Years - 45 YearsFemaleIsfahan University of Medical Sciences
NCT06642363 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age 18 - 45 years 2. Clinical diagnosis of polycystic ovary syndrome 3. Have a body mass index of 25-35 kg/m 2 4. Absence of pregnancy and breastfeeding 5. No intake of medicine 6. Not willing to get pregnant during the study 7. No presence of chronic inflammatory diseases or other endocrine disorders 8. No current treatments except metformin 9. No intake of dietary supplements within at last 2 previous months Exclusion Criteria: 1. Consuming less than 80% of the total administered ASX supplements 2. Ongoing pregnancy 3. Changing their usual diet or eating habits or level of physical activity 4. Presence of Skin or digestive allergy symptoms or any desired complications by intake of ASX supplementation 5. Smoking or alcohol consumption
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What it tests

  • 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
  • Placebo
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Where

1 site
Isfahan university of medical sciences
Isfahan, Iran
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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