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

NCT06642363 | Recruiting Phase 1 DMC

• 1 other identifier: IR.MUI.RESEARCH.REC.1402.204
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

PCO - Polycystic Ovaries; Obesity and Obesity-related Medical Conditions

Keywords

Astaxanthin; Polycystic Ovary Syndrome; Obesity; Hirsutism

Outcome Measures

Primary Outcomes (5)

• Blood pressure measurement

  To measure blood pressure, patients were asked to rest for 10 minutes, then the measurement was done using a mercury sphygmomanometer (Riester, Germany). The blood pressure of each person will be measured twice with a time interval of 10 minutes, in a sitting position, from the right arm and at the level of the heart. The average of these two measurements was considered as the patient's blood pressure. Before taking blood pressure, patients will be asked about smoking or drinking coffee in the previous 2 hours

  From enrollment to the end of treatment at 8 weeks

• Evaluation of the severity of hirsutism

  To assess the severity of hirsutism, the amount of total body hair in nine sits (upper lip, chin, chest, upper and lower abdomen, thigh, upper and lower back, and upper arm) will be evaluated according to the modified Ferriman-Gallwey (mFG) scoring system. In this system, each body sit will be visually scored on a scale of 0 to 4, and the maximum score of each participant could be 16. The final score of 0 to 3 will be measured as non-hirsutism, 4 to 7 will be considered mild hirsutism, and 8 Up to 11 and 12 to 16 will reflect moderate hirsutism and severe hirsutism, respectively. Subjects will be asked to not use any removing hair methods during the study.

  From enrollment to the end of treatment at 8 weeks

• Evaluation of biochemical indicators

  On days zero (before the start of the intervention) and day 80 (the end of the intervention), 10 cc of blood is taken from the patient in the morning and collected in a plastic tube. It is left with 3,600 revolutions for 3-4 minutes and poured into microtubes containing 0.5 ml. The samples are stored in a freezer at -70°C. To reduce the measurement error, all samplings are done at 8-10 in the morning and in the fasting state. Blood samples taken from patients at the beginning and end of the study are centrifuged for 10 minutes at 300 rpm to separate their serum. Serum values of lipid profile (triglyceride (TG) level, total cholesterol, Low-density lipoprotein cholesterol (LDL-c), and High-density lipoprotein cholesterol (HDL-c) serum) are measured by enzymatic colorimetric method. To measure serum cholesterol, cholesteryl ester enzymes are then added to the solution, and cholesterol oxidase is finally converted into cholesterol-4-en-3-one H₂O₂ and the cholesterol concentration of the

  From enrollment to the end of treatment at 8 weeks

• Physical Activity Assessment Questionnaire

  The physical activity evaluation of the participants will be recorded by the short form of the International Physical Activity Questionnaire (IPAQ) 4 times (at the baseline, 4-week, 8-week, and the end of the study)(22). To obtain the overall physical activity score based on MET-minutes/week, the score obtained from 3 activity categories including walking, moderate physical activity, and vigorous physical activity will be recorded.

  4 times (at the baseline, 4-week, 8-week, and the end of the study)

• Dietary intake assessment

  The individual's dietary intake will be evaluated using a 24-hour dietary recall in the four scenarios (at the baseline, 4-week, 8-week, and the end of the study) by a trained nutritionist. the reported amounts of each food and drink consumed will be converted to grams per day using the household guidebook(20). Diet information analysis will be done using Nutritionist IV software (First Databank, Hearst Corp, San Bruno, CA, USA)

  at the baseline, 4-week, 8-week, and the end of the study)

Study Arms (2)

Drug

EXPERIMENTAL

receiving ASX supplements

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

control

PLACEBO COMPARATOR

receiving placebo

Drug: Placebo

Interventions

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

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 DRUG

The placebo group will take one capsule containing corn starch in a wrapped and covered form and the appearance of ASX supplementation (blinding).

control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: eligible women with PCOS and a body mass index of 25-35 kg/m2, who are referred to the gynecologist clinic in Isfahan, Iran,
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 - 45 years
• Clinical diagnosis of polycystic ovary syndrome
• Have a body mass index of 25-35 kg/m 2
• Absence of pregnancy and breastfeeding
• No intake of medicine
• Not willing to get pregnant during the study
• No presence of chronic inflammatory diseases or other endocrine disorders
• No current treatments except metformin
• No intake of dietary supplements within at last 2 previous months

You may not qualify if:

• Consuming less than 80% of the total administered ASX supplements
• Ongoing pregnancy
• Changing their usual diet or eating habits or level of physical activity
• Presence of Skin or digestive allergy symptoms or any desired complications by intake of ASX supplementation
• Smoking or alcohol consumption

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

Study Sites (1)

Isfahan university of medical sciences

Isfahan, Isfahan, 8174673461, Iran

RECRUITING

Related Publications (20)

• 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.

  PMID: 35237893 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.

  PMID: 36854788 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.

  PMID: 21480416 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.

  PMID: 19622498 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.

  PMID: 31788888 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.

  PMID: 32086359 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.

  PMID: 16418209 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.

  PMID: 37736515 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.

  PMID: 29384321 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.

  PMID: 36363994 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.

  PMID: 35388031 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.

  PMID: 35960093 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.

  PMID: 29322000 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.

  PMID: 21339935 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.

  PMID: 24002410 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.

  PMID: 23114091 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.

  PMID: 29962792 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.

  PMID: 17692530 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.

  PMID: 34578816 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.

  PMID: 10566641 BACKGROUND

MeSH Terms

Conditions

Obesity; Polycystic Ovary Syndrome; Hirsutism

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Virilism

Study Officials

• Nafiseh Shokri-Mashhadi, Dr.

  Isfahan University of Medical Sciences

  STUDY DIRECTOR

Central Study Contacts

Nafiseh Shokri-Mashhadi, Dr.

CONTACT

+989134312432; miladnacri@gmail.com

Milad Nasiri Jounaghani

CONTACT

+989338033133; miladnasiri.j@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: In this study, the individual conducting the blood test, the one prescribing the supplements, and the person analyzing the data are unaware of the division of participants into two groups: drug and placebo. Since the astaxanthin supplement and placebo are identical in color and shape, patients are also unaware of this division.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Masking In this study, the individual conducting the blood test, the one prescribing the supplements, and the person analyzing the data are unaware of the division of participants into two groups: drug and placebo. Since the astaxanthin supplement and placebo are identical in color and shape, patients are also unaware of this division. Blinding All baseline assessments will be conducted before randomization, and certain assessments will be performed with blinding for group allocation.

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 15, 2024
• Study Start: July 22, 2024
• Primary Completion: July 22, 2025
• Study Completion: July 22, 2025
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)