Quzhou Population Cohort Research Project (Aging Related Research: Intervention of Nicotinamide Mononucleotide in Middle-aged and Elderly People)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Comprehensive evaluation of NMN in reducing biological age
研究概览
简要总结
This study is a single-center, randomized, double-blind, placebo-controlled clinical trial investigating a pharmacological intervention for aging. Its primary objective is to evaluate the efficacy of NMN while ensuring the safety of oral administration, with the aim of identifying effective strategies to delay aging and improve the quality of life in the elderly population. The main outcomes of this study are to characterize the patterns of NMN efficacy across different populations and to identify sensitive biomarkers that reflect responsiveness to the intervention.
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
- 39 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Local residents of Quzhou or living in Quzhou for over ten years.
- •age 40-50 and 60-70 years old, no major bad habits.
- •Gender unlimited.
- •in good health and has not undergone major surgery within half a year.
- •Be able to communicate well with researchers and cooperate with the work during the study.
- •Written informed consent can be signed voluntarily.
排除标准
- •Alcoholism, heavy smoking (more than 5 packs/day, 20 cigarettes per pack), drug abuse or substance abuse.
- •Participants are conducting other clinical trials or using any research drugs or equipment for treatment within 30 days before enrollment (including but not limited to aspirin, metformin, resveratrol, vitamin C, etc.).
- •Obesity (bmi more than 30).
- •Pregnant/lactating women.
- •Disease history:
- •A) under 60 years old:
- •any cancer (erythrocytosis, except basal cell or squamous cell skin cancer).
- •coronary artery disease/myocardial infarction/clinically significant congestive heart failure.
- •stroke/transient ischemic attack.
- •deep vein thrombosis/pulmonary embolism.
- •serum creatinine > 1.5 mg/dl (male).
- •poor control of hypertension (although treated, there is still significant hypertension (systolic blood pressure > 160 mmHg, or diastolic blood pressure >100 mmHg)).
- •history of active liver disease or metabolic acidosis.
- •chronic kidney disease/hemodialysis treatment, history of severe kidney damage and/or EGFR ≤ 45ml/min/1.73m
- •severe autoimmunity/inflammation, such as rheumatoid arthritis, lupus, Crohn's disease, etc.
- •nervous system diseases such as dementia, such as Alzheimer/Parkinson's disease.
- •diabetes mellitus (hemoglobin > 6.5% or fasting blood glucose > 126 mg/dL or taking diabetes drugs or insulin treatment).
- •recent (within 3 months) cardiovascular events (myocardial infarction, coronary intervention, coronary artery bypass grafting).
- •infectious diseases such as HIV, hepatitis, tuberculosis, etc.
- •hand or lower limb disability affects normal function and life.
- •B) older than 60 years:
- •any cancer (erythrocytosis, except basal cell or squamous cell skin cancer).
- •history of active liver disease or metabolic acidosis.
- •chronic kidney disease/hemodialysis treatment, history of severe kidney damage and/or EGFR ≤ 45ml/min/1.73m
- •severe autoimmunity/inflammation, such as lupus, Crohn's disease, etc.
- •nervous system diseases such as dementia, such as Alzheimer/Parkinson's disease.
- •recent (within 3 months) cardiovascular events (myocardial infarction, coronary intervention, coronary artery bypass grafting).
- •infectious diseases such as HIV, hepatitis, tuberculosis, etc.
- •hand or lower limb disability affects normal function and life.
- •Currently taking the following drugs regularly:
- •A) chemotherapy drugs (such as tamoxifen, adriamycin, mitoxantrone, bleomycin). B) antiplatelet drugs (e.g., clopidogrel/Plavix, dipyridamole/anglionide, ticlopidine/ticlopidine, except aspirin).
- •C) cholinesterase inhibitors for Alzheimer's disease (donepezil/alicept).
- •The researchers believe that the physical factors of the participants may have an adverse impact on the research process or results.
研究组 & 干预措施
NMN treated (middle-aged male)
NMN Arm participants (middle-aged male) took one capsule (containing 350mg NMN) with breakfast daily for one year.
干预措施: NMN (Dietary Supplement)
NMN treated (old female)
NMN Arm participants (old female) took one capsule (containing 350mg NMN) with breakfast daily for one year.
干预措施: NMN (Dietary Supplement)
NMN treated (middle-aged female)
NMN Arm participants (middle-aged female) took one capsule (containing 350mg NMN) with breakfast daily for one year.
干预措施: NMN (Dietary Supplement)
Placebo (middle-aged male)
Placebo arm participants (middle-aged male) took one capsule (appearance and odor are the same as NMN) with breakfast daily for one year.
干预措施: placebo (Dietary Supplement)
NMN treated (old male)
NMN Arm participants (old male) took one capsule (containing 350mg NMN) with breakfast daily for one year.
干预措施: NMN (Dietary Supplement)
Placebo (middle-aged female)
Placebo arm participants (middle-aged female) took one capsule (appearance and odor are the same as NMN) with breakfast daily for one year.
干预措施: placebo (Dietary Supplement)
Placebo (old male)
Placebo arm participants (old male) took one capsule (appearance and odor are the same as NMN) with breakfast daily for one year.
干预措施: placebo (Dietary Supplement)
Placebo (old female)
Placebo arm participants (old female) took one capsule (appearance and odor are the same as NMN) with breakfast daily for one year.
干预措施: placebo (Dietary Supplement)
结局指标
主要结局
Comprehensive evaluation of NMN in reducing biological age
时间窗: Baseline, 6 months and 12 months
Change in biological age from baseline to 12 months, quantified using predefined multi-layer aging clock(s). Biological age will be assessed using the following measures: 1. Transcriptomic age (years) 2. DNA methylation age (years) 3. Proteomic age (years) 4. Metabolomic age (years) 5. Phenotypic age (years) The primary endpoint will be defined as: Change from baseline to 12 months in a prespecified composite biological age score, derived from the above aging clocks using a predefined integration method (e.g., standardized z-score aggregation or principal component-based integration). A reduction in biological age is defined as a decrease in the composite biological age score.
次要结局
- Composite through clinical physical examination data, behavioral indicators and multilevel omics data, to discover new sensitive biomarkers for evaluating aging.(Baseline, 6 months and 12 months)
研究者
Feng Zhang
researcher
People's Hospital of Quzhou