Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Obesity and Obesity-related Medical Conditions | — | UNRESOLVED | — |
| PCO - Polycystic Ovaries | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| 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 | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Drug
- description
- receiving ASX supplements
- interventionNames
- 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
- type
- PLACEBO_COMPARATOR
- label
- control
- description
- receiving placebo
- interventionNames
- Drug: Placebo
Primary outcomes (5)
- measure
- Blood pressure measurement
- timeFrame
- From enrollment to the end of treatment at 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18 - 45 years 2. Clinical diagnosis of polycystic ovary syndrome 3. Have a body mass index of 25-35 kg/m 2 4. Absence of pregnancy and breastfeeding 5. No intake of medicine 6. Not willing to get pregnant during the study 7. No presence of chronic inflammatory diseases or other endocrine disorders 8. No current treatments except metformin 9. No intake of dietary supplements within at last 2 previous months Exclusion Criteria: 1. Consuming less than 80% of the total administered ASX supplements 2. Ongoing pregnancy 3. Changing their usual diet or eating habits or level of physical activity 4. Presence of Skin or digestive allergy symptoms or any desired complications by intake of ASX supplementation 5. Smoking or alcohol consumption
References
Publications (20)
- BACKGROUNDGharaei R, Alyasin A, Mahdavinezhad F, Samadian E, Ashrafnezhad Z, Amidi F. Randomized controlled trial of astaxanthin impacts on antioxidant status and assisted reproductive technology outcomes in women with polycystic ovarian syndrome. J Assist Reprod Genet. 2022 Apr;39(4):995-1008. doi: 10.1007/s10815-022-02432-0. Epub 2022 Mar 3. PMID 35237893
- BACKGROUNDJabarpour M, Aleyasin A, Nashtaei MS, Lotfi S, Amidi F. Astaxanthin treatment ameliorates ER stress in polycystic ovary syndrome patients: a randomized clinical trial. Sci Rep. 2023 Feb 28;13(1):3376. doi: 10.1038/s41598-023-28956-8. PMID 36854788
- BACKGROUNDChoi HD, Kim JH, Chang MJ, Kyu-Youn Y, Shin WG. Effects of astaxanthin on oxidative stress in overweight and obese adults. Phytother Res. 2011 Dec;25(12):1813-8. doi: 10.1002/ptr.3494. Epub 2011 Apr 8. PMID 21480416
- BACKGROUNDPapathanasiou G, Georgoudis G, Papandreou M, Spyropoulos P, Georgakopoulos D, Kalfakakou V, Evangelou A. Reliability measures of the short International Physical Activity Questionnaire (IPAQ) in Greek young adults. Hellenic J Cardiol. 2009 Jul-Aug;50(4):283-94. PMID 19622498
- BACKGROUNDBrendler T, Williamson EM. Astaxanthin: How much is too much? A safety review. Phytother Res. 2019 Dec;33(12):3090-3111. doi: 10.1002/ptr.6514. Epub 2019 Dec 1. PMID 31788888
- BACKGROUNDKiel IA, Lionett S, Parr EB, Jones H, Roset MAH, Salvesen O, Vanky E, Moholdt T. Improving reproductive function in women with polycystic ovary syndrome with high-intensity interval training (IMPROV-IT): study protocol for a two-centre, three-armed randomised controlled trial. BMJ Open. 2020 Feb 20;10(2):e034733. doi: 10.1136/bmjopen-2019-034733. PMID 32086359
- BACKGROUNDFranks S. Controversy in clinical endocrinology: diagnosis of polycystic ovarian syndrome: in defense of the Rotterdam criteria. J Clin Endocrinol Metab. 2006 Mar;91(3):786-9. doi: 10.1210/jc.2005-2501. Epub 2006 Jan 17.