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

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)

Timeline

Start

2024-07-22

Primary completion

2025-07-22

Completion

2025-07-22

Publications

• Background Gharaei 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.
• Background Jabarpour 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.
• Background Choi 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.
• Background Papathanasiou 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.
• Background Brendler 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.
• Background Kiel 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.
• Background Franks 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.
• Background Toktay E, Selli J, Gurbuz MA, Alaca R. Investigation of the effects of astaxanthin in experimental polycystic ovary syndrome (PCOS) in rats. Iran J Basic Med Sci. 2023;26(10):1155-1161. doi: 10.22038/IJBMS.2023.69984.15223.
• Background Mashhadi NS, Zakerkish M, Mohammadiasl J, Zarei M, Mohammadshahi M, Haghighizadeh MH. Astaxanthin improves glucose metabolism and reduces blood pressure in patients with type 2 diabetes mellitus. Asia Pac J Clin Nutr. 2018;27(2):341-346. doi: 10.6133/apjcn.052017.11.
• Background Bjorklund G, Gasmi A, Lenchyk L, Shanaida M, Zafar S, Mujawdiya PK, Lysiuk R, Antonyak H, Noor S, Akram M, Smetanina K, Piscopo S, Upyr T, Peana M. The Role of Astaxanthin as a Nutraceutical in Health and Age-Related Conditions. Molecules. 2022 Oct 23;27(21):7167. doi: 10.3390/molecules27217167.
• Background Tefagh G, Payab M, Qorbani M, Sharifi F, Sharifi Y, Ebrahimnegad Shirvani MS, Pourghazi F, Atlasi R, Shadman Z, Rezaei N, Mohammadi-Vajari E, Larijani B, Ebrahimpur M. Effect of vitamin E supplementation on cardiometabolic risk factors, inflammatory and oxidative markers and hormonal functions in PCOS (polycystic ovary syndrome): a systematic review and meta-analysis. Sci Rep. 2022 Apr 6;12(1):5770. doi: 10.1038/s41598-022-09082-3.
• Background Zhao J, Sui X, Shi Q, Su D, Lin Z. Effects of antioxidant intervention in patients with polycystic ovarian syndrome: A systematic review and meta-analysis. Medicine (Baltimore). 2022 Aug 12;101(32):e30006. doi: 10.1097/MD.0000000000030006.
• Background Borzoei A, Rafraf M, Niromanesh S, Farzadi L, Narimani F, Doostan F. Effects of cinnamon supplementation on antioxidant status and serum lipids in women with polycystic ovary syndrome. J Tradit Complement Med. 2017 May 19;8(1):128-133. doi: 10.1016/j.jtcme.2017.04.008. eCollection 2018 Jan.
• Background Badawy A, Elnashar A. Treatment options for polycystic ovary syndrome. Int J Womens Health. 2011 Feb 8;3:25-35. doi: 10.2147/IJWH.S11304.
• Background Panidis D, Tziomalos K, Papadakis E, Katsikis I. Infertility treatment in polycystic ovary syndrome: lifestyle interventions, medications and surgery. Front Horm Res. 2013;40:128-41. doi: 10.1159/000341824. Epub 2012 Oct 18.
• Background Lim SS, Norman RJ, Davies MJ, Moran LJ. The effect of obesity on polycystic ovary syndrome: a systematic review and meta-analysis. Obes Rev. 2013 Feb;14(2):95-109. doi: 10.1111/j.1467-789X.2012.01053.x. Epub 2012 Oct 31.
• Background Sadeeqa S, Mustafa T, Latif S. Polycystic Ovarian Syndrome-Related Depression in Adolescent Girls: A Review. J Pharm Bioallied Sci. 2018 Apr-Jun;10(2):55-59. doi: 10.4103/JPBS.JPBS_1_18.
• Background Diamanti-Kandarakis E, Papavassiliou AG, Kandarakis SA, Chrousos GP. Pathophysiology and types of dyslipidemia in PCOS. Trends Endocrinol Metab. 2007 Sep;18(7):280-5. doi: 10.1016/j.tem.2007.07.004. Epub 2007 Aug 10.
• Background Dubey P, Reddy S, Boyd S, Bracamontes C, Sanchez S, Chattopadhyay M, Dwivedi A. Effect of Nutritional Supplementation on Oxidative Stress and Hormonal and Lipid Profiles in PCOS-Affected Females. Nutrients. 2021 Aug 25;13(9):2938. doi: 10.3390/nu13092938.
• Background Diamanti-Kandarakis E, Kouli CR, Bergiele AT, Filandra FA, Tsianateli TC, Spina GG, Zapanti ED, Bartzis MI. A survey of the polycystic ovary syndrome in the Greek island of Lesbos: hormonal and metabolic profile. J Clin Endocrinol Metab. 1999 Nov;84(11):4006-11. doi: 10.1210/jcem.84.11.6148.

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