NCT06642363 The Effectiveness of Astaxanthin Supplementation on the Clinical Symptoms and Cardio-metabolic Profile in Women with Polycystic Ovary Syndrome
| NCT ID | NCT06642363 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Isfahan University of Medical Sciences |
| Condition | PCO - Polycystic Ovaries |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2024-07-22 |
| Primary Completion | 2025-07-22 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 44 participants in total. It began in 2024-07-22 with a primary completion date of 2025-07-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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)
Eligibility Criteria
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
Contact & Investigator
Nafiseh Shokri-Mashhadi, Dr.
STUDY DIRECTOR
Isfahan University of Medical Sciences
Frequently Asked Questions
Who can join the NCT06642363 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying PCO - Polycystic Ovaries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06642363 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06642363 currently recruiting?
Yes, NCT06642363 is actively recruiting participants. Contact the research team at miladnacri@gmail.com for enrollment information.
Where is the NCT06642363 trial being conducted?
This trial is being conducted at Isfahan, Iran.
Who is sponsoring the NCT06642363 clinical trial?
NCT06642363 is sponsored by Isfahan University of Medical Sciences. The principal investigator is Nafiseh Shokri-Mashhadi, Dr. at Isfahan University of Medical Sciences. The trial plans to enroll 44 participants.