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

Recruiting · NCT06642363 · Interventional (participants receive a specific treatment) · Lead sponsor: Isfahan University of Medical Sciences

View the official record on ClinicalTrials.gov →

Obesity PCOS

Interventions studied

PlaceboSubjects 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

What this trial is about

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)

Who can take part

Age range

18 Years to 45 Years

Sex

Female

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 1

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

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 criteria

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

Where it is running

1 location listed.

Isfahan university of medical sciences - Isfahan, Isfahan, Iran

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →