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RECRUITING
NCT06642363
PHASE1

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

Sponsor: Isfahan University of Medical Sciences

View on ClinicalTrials.gov

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)

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

44

Start Date

2024-07-22

Completion Date

2025-07-22

Last Updated

2024-10-17

Healthy Volunteers

No

Interventions

DRUG

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

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

DRUG

Placebo

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)

Isfahan university of medical sciences

Isfahan, Isfahan, Iran