The Effectiveness of Astaxanthin Supplementation on the Clinical Symptoms and Cardio-metabolic Profile in 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
Isfahan University of Medical Sciences
44 participants
Jul 22, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria9
- Age 18 - 45 years
- Clinical diagnosis of polycystic ovary syndrome
- Have a body mass index of 25-35 kg/m 2
- Absence of pregnancy and breastfeeding
- No intake of medicine
- Not willing to get pregnant during the study
- No presence of chronic inflammatory diseases or other endocrine disorders
- No current treatments except metformin
- No intake of dietary supplements within at last 2 previous months
Exclusion Criteria5
- Consuming less than 80% of the total administered ASX supplements
- Ongoing pregnancy
- Changing their usual diet or eating habits or level of physical activity
- Presence of Skin or digestive allergy symptoms or any desired complications by intake of ASX supplementation
- Smoking or alcohol consumption
Interventions
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
The placebo group will take one capsule containing corn starch in a wrapped and covered form and the appearance of ASX supplementation (blinding).
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06642363