Actively Recruiting

Phase 1
Age: 18Years - 45Years
FEMALE
NCT06642363

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

Led by Isfahan University of Medical Sciences · Updated on 2024-10-17

44

Participants Needed

1

Research Sites

52 weeks

Total Duration

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AI-Summary

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)

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 - 45 years
  • Clinical diagnosis of polycystic ovary syndrome
  • Body mass index of 25-35 kg/m2
  • Not pregnant or breastfeeding
  • No current medication use except metformin
  • Not planning pregnancy during the study
  • No chronic inflammatory or other endocrine disorders
  • No dietary supplement intake in the last 2 months
Not Eligible

You will not qualify if you...

  • Taking less than 80% of assigned astaxanthin supplements
  • Currently pregnant
  • Changes in usual diet, eating habits, or physical activity during the study
  • Presence of skin or digestive allergies or complications from astaxanthin
  • Smoking or alcohol use

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Isfahan university of medical sciences

Isfahan, Isfahan, Iran, 8174673461

Actively Recruiting

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Research Team

N

Nafiseh Shokri-Mashhadi, Dr.

CONTACT

M

Milad Nasiri Jounaghani

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

2

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