RecruitingPhase 1NCT06642363

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

Sponsor

Isfahan University of Medical Sciences

Enrollment

44 participants

Start Date

Jul 22, 2024

Study Type

INTERVENTIONAL

Conditions

PCO - Polycystic Ovaries Obesity and Obesity-related Medical 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

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether astaxanthin (a natural antioxidant supplement found in seafood like salmon and shrimp) can improve symptoms and metabolic health markers in women with polycystic ovary syndrome (PCOS). **You may be eligible if...** - You are a woman between 18 and 45 years old - You have been diagnosed with PCOS - Your BMI is between 25 and 35 kg/m² - You are not pregnant or breastfeeding and do not plan to become pregnant during the study - You are not taking any medications (except metformin) and have not taken dietary supplements in the past 2 months **You may NOT be eligible if...** - You smoke or consume alcohol - You have a skin or digestive allergy to astaxanthin - You plan to significantly change your diet or exercise habits during the study - You develop an ongoing pregnancy during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSubjects 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

DRUGPlacebo

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

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NCT06642363

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