Astaxanthin supplementation for women with Polycystic Ovary Syndrome
The Effectiveness of Astaxanthin Supplementation on the Clinical Symptoms and Cardio-metabolic Profile in Women with Polycystic Ovary Syndrome: a Protocol for a Randomized Double-blinded, Placebo-controlled Parallel-group Study
This study is testing if taking astaxanthin for 12 weeks can help women with Polycystic Ovary Syndrome feel better by improving symptoms like insulin sensitivity and mood.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Isfahan University of Medical Sciences Academic / other |
| Locations | 1 site (Isfahan, Isfahan) |
| Trial ID | NCT06642363 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effects of 12 weeks of astaxanthin supplementation at a dosage of 10 mg per day on various clinical symptoms and metabolic profiles in women diagnosed with Polycystic Ovary Syndrome (PCOS). The study will compare the outcomes of participants receiving astaxanthin to those in a control group, focusing on insulin sensitivity, lipid profiles, hirsutism severity, and depression levels. Conducted at Isfahan University of Medical Sciences in Iran, the trial aims to provide insights into the potential benefits of astaxanthin as an auxiliary treatment for PCOS. Eligible participants will have a body mass index between 25 and 35 kg/m² and will be monitored throughout the study period.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 to 45 with a clinical diagnosis of PCOS and a body mass index of 25-35 kg/m².
Not a fit: Patients who are pregnant, breastfeeding, or have chronic inflammatory diseases or other endocrine disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new dietary supplement option to improve metabolic and psychological symptoms in women with PCOS.
How similar studies have performed: While this approach is relatively novel, previous studies have indicated positive effects of antioxidant supplementation in managing complications associated with PCOS.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Isfahan, Isfahan
- Isfahan university of medical sciences — Isfahan, Isfahan, Iran (Recruiting)
Study contacts
- Study coordinator: Nafiseh Shokri-Mashhadi, Dr.
- Email: miladnacri@gmail.com
- Phone: +989134312432
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.