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
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Blood pressure measurement
研究概览
简要总结
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)
详细描述
Introduction Polycystic Ovary Syndrome (PCOS) is a significant endocrine disorder affecting women of reproductive age, associated with common symptoms, including anovulation, infertility, metabolic dysfunction, cardiovascular issues, dyslipidemia, as well as clinical manifestations related to hyperandrogenism. his condition not only leads to reproductive issues but is also linked to psychological disorders, such as depression. The exact etiology of PCOS remains incompletely understood; however, it is suggested that, alongside genetic factors, insulin resistance, an abnormal rise in circulating testosterone levels, and obesity-related inflammation may contribute to ovarian dysfunction.
lifestyle intervention is the current recommendation that could enhance anthropometric indices, cardio-metabolic markers, and reproductive characteristics of women with PCOS. Recent evidence indicated that the administration of lipid-soluble antioxidants may influence lipid profiles and lipid peroxidation levels in individuals with PCOS. Furthermore, previous studies have reported the positive effects of supplementation with antioxidants on other complications associated with PCOS, including inflammatory markers and insulin resistance.
Astaxanthin (ASX) is a carotenoid fat-soluble pigment with potential antioxidant properties naturally found in certain seafood and a specific type of algae. As a consequence of the unique molecular structure of this component, the beneficial effects of ASX on various health aspects involving lipid profile, blood pressure, and depression have been proposed by recent studies . Several experimental investigations also indicated the anti-oxidative and anti-inflammatory impact of ASX supplementation in various PCOS models; however, there are limited studies on the impact of ASX on the cardio-metabolic profile, inflammatory biomarkers, and clinical manifestation of women with PCOS. This paper will describe the design, methodology, and potential clinical implications of the impact of ASX supplementation in women with PCOS.
Thus, this trial aims to investigate the effect of 12 weeks of 10 mg/day astaxanthin administration compared to a control group on insulin sensitivity, lipid profile, circulating Malondialdehyde (MDA) levels, severity of hirsutism, and depression in women with PCOS.
Material and methods Study setting and recruitment This is a single-center double-blind, randomized controlled clinical trial with two parallel groups: one intervention group and one control group. Eligible women with PCOS who are referred to the collaborating gynecologist clinic in Isfahan, Iran, in 2024-2025, will be recruited in this study. After outlining the study's objectives, written informed consent will be obtained from all participants. All participants will be assigned a project-specific code that will be used throughout all data analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Drug
receiving ASX supplements
干预措施: 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)
control
receiving placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Blood pressure measurement
时间窗: From 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 hirsutism
时间窗: From 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 indicators
时间窗: From 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 oxidase is finally converted into cholesterol-4-en-3-one H₂O₂ and the cholesterol concentration of the
Physical Activity Assessment Questionnaire
时间窗: 4 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 assessment
时间窗: at 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)
次要结局
未报告次要终点
研究者
Milad Nasiri Jounaghani
Principal Investigator
Isfahan University of Medical Sciences