NCT05305677已完成不适用
Effect of NMN (Nicotinamide Mononucleotide) Intervention on Patients With Polycystic Ovary Syndrome
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Testosterone level
研究概览
简要总结
The purpose of the study is to understand the effect of Nicotinamide mononucleotide (NMN) on patients with polycystic ovary syndrome.
详细描述
This study aims to evaluate the effects of NMN on reproductive endocrine and metabolism, chronic inflammation, and reproductive outcomes in women with polycystic ovary syndrome (PCOS), and to explore its underlying mechanisms to provide the intervention strategies for PCOS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Individuals who are 20 to 40 years old;
- •BMI < 25 kg/m2;
- •Individuals with PCOS should meet all the Rotterdam diagnostic criteria: 1) Oligo- and/or anovulation; 2) Clinical and/or biochemical signs of hyperandrogenism; 3) Polycystic ovaries, and exclusion of other aetiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome).
- •Individuals who can insist on continuous monitoring in the outpatient clinic.
- •Individuals who are not participating in other research projects currently or 3 months before the intervention.
排除标准
- •Individuals who suffering from other diseases that may cause hyperandrogenism and ovulation abnormalities.
- •Individuals who are during pregnant, lactation or menopause.
- •Individuals who currently receiving weight-loss drugs or surgery or within the past 2 months.
- •Individuals who take niacin, nicotinamide, or other vitamin B-related supplementation currently or within the past 2 months.
- •Individuals who need regular medication to treat chronic diseases such as diabetes, hypertension, gout, hyperuricemia, etc.
- •Use of medications that affect hormone levels, appetite, carbohydrate absorption, and metabolism within the past 2 months.
- •Individuals with severe liver diseases or kidney disease that are ineligible to participate in the study.
- •A medical history of severe cardiovascular and cerebrovascular diseases.
- •Individuals who currently suffer from severe gastrointestinal diseases or undergo gastrointestinal resection that may affect nutrient absorption.
- •Individuals who drink more than 15g of alcohol per day or have a smoking habit.
- •Individuals who need drug treatment for any mental illness such as epilepsy and depression.
- •Cancer patients.
- •Individuals who suffer from infectious diseases such as hepatitis B, active tuberculosis, AIDS, etc.
结局指标
主要结局
Testosterone level
时间窗: From enrollment to the end of treatment at 8 weeks
Changes of testosterone level in serum after intervention.
Antral follicle counts
时间窗: From enrollment to the end of treatment at 8 weeks
The number of antral follicle counts in each ovary will be determined using transvaginal ultrasonography for each participant.
Menstrual cycle
时间窗: before and after 8 weeks of intervention
The changes of menstrual cycle frequency after intervention.
次要结局
- Luteinizing hormone (LH) level(From enrollment to the end of treatment at 8 weeks)
- Follicle-stimulating hormone (FSH) level(From enrollment to the end of treatment at 8 weeks)
- Homeostasis Model Assessment for Insulin Resistance (HOMA-IR) index(From enrollment to the end of treatment at 8 weeks)
- Changes in other endocrine hormones(From enrollment to the end of treatment at 8 weeks)
- Changes in blood NAD+ level and related metabolites(From enrollment to the end of treatment at 8 weeks)
- Multi-omics(From enrollment to the end of treatment at 8 weeks)
研究者
研究点 (1)
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