|

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

RECRUITINGPhase 1Sponsored by Isfahan University of Medical Sciences
Actively Recruiting
PhasePhase 1
SponsorIsfahan University of Medical Sciences
Started2024-07-22
Est. completion2025-07-22
Eligibility
Age18 Years – 45 Years
SexFEMALE
Healthy vol.Accepted

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

Age: 18 Years – 45 YearsSex: FEMALEHealthy volunteers accepted
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

Conditions3

CancerObesity and Obesity-related Medical ConditionsPCO - Polycystic Ovaries

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.