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

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: PCO - Polycystic Ovaries, Obesity and Obesity-related Medical Conditions

In brief

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)

Key facts

Study ID

NCT06642363

Run by

Isfahan University of Medical Sciences

People needed

44

Starts

2024-07-22

Expected to finish

2025-07-22

Last updated by the study team

2024-10-17

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• Isfahan university of medical sciences — Isfahan, Isfahan, Iran (enrolling)

Full record on ClinicalTrials.gov

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