Clinical trial

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

Recruiting now · Phase 1 · 1 countries · Registry ID NCT06642363

Recruiting nowPhase 1Interventional

What this study 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)

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 45 Years
SexFemale
Healthy volunteersNot accepted
ConditionPCO - Polycystic Ovaries, Obesity and Obesity-related Medical Conditions

Full registry criteria

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

Treatments and study arms

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

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).

Primary outcomes

Blood pressure measurementFrom enrollment to the end of treatment at 8 weeks

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

Evaluation of the severity of hirsutismFrom enrollment to the end of treatment at 8 weeks

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.

Evaluation of biochemical indicatorsFrom enrollment to the end of treatment at 8 weeks

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 oxi…

Physical Activity Assessment Questionnaire4 times (at the baseline, 4-week, 8-week, and the end of the study)

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.

Dietary intake assessmentat the baseline, 4-week, 8-week, and the end of the study)

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)

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Isfahan university of medical sciences🌐 Isfahan, Isfahan, Iran
Nafiseh Shokri-Mashhadi, DrContact