The Impact of Nicotinamide Mononucleotide Sustained-release Tablets on Immunosenescence and Metablism in Middle-aged and Elderly Individuals With Metabolic Disorders.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- CD3+CD8+CD27-CD28- T cells as a percentage of CD3+CD8+ T cells, expressed in %, evaluated by flow cytometry
研究概览
简要总结
The ageing of our country is increasing and the ageing of the population has led to a significant increase in aging related diseases. During the aging process of the organism, cellular senescence can occur in all systems of the body, of which the senescence of the immune system is called immunosenescence. Some studies have shown that metabolic disorders can also trigger aging. This study investigated the effect of nicotinamide mononucleotide (NMN) supplementation on immunosenescence in middle-aged and elderly people through a placebo-controlled long-range clinical trail, aiming to provide a new method to improve immunosenescence. The effects of NMN supplementation on glucose and lipid metabolic indexes, body composition and telomere length of peripheral blood cells are also investigated, which may open up new ideas for the prevention and treatment of glucose and lipid metabolic diseases.
详细描述
A randomised, placebo-controlled, parallel group study to assess the efficacy and safety of NMN in middle-aged and elderly people with immunosenescence. People aged 50-70 years will be included in the study. Participants will be given NMN SR tablets (1000mg/tablet) or placebo, 1 tablet daily before breakfast. The study treatment period lasts 26 weeks. Investigator visits will be conducted at months 1, 3 and 6. Percentage of CD3+CD8+CD27-CD28- cells to total CD3+CD8+ T cells will be used as the primary evaluation metrics for assessing efficacy.Liver fat content, body composition analysis, pancreatic β-cell function, telomere length, fasting blood glucose, glycosylated hemoglobin, and cardiorespiratory fitness will be used as secondary indicators for efficacy assessment. Physiological and biochemical parameters such as blood and urine routine, liver and kidney function will be used for safety assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50-70 years with overweight or obesity (BMI 24kg/m2);
- •At least one of the following three: metabolism-related fatty liver disease (diagnosed by ultrasound); pre-diabetes; type 2 diabetes mellitus with HbA1c <7% without glucose-lowering drug therapy;
- •Agreed to participate in the trial and could adhere to the follow-up and visit the hospital on their own; signed the informed consent form.
排除标准
- •Patients with tumours;
- •Patients with autoimmune diseases (excluding Hashimoto's thyroiditis);
- •Severe cardiovascular disease or cardiac insufficiency;
- •Systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg;
- •Chronic obstructive pulmonary disease;
- •Chronic active hepatitis or cirrhosis;
- •Chronic renal insufficiency;
- •Stroke patients
- •Severe haematological diseases;
- •Infectious diseases;
- •Mental illness;
- •Other conditions that, in the opinion of the investigator, may affect the results of the study;
- •Those who have used NMN or other anti-aging agents within six months.
- •Premenopausal woman
- •ALT, AST values are more than three times higher than the upper limit of the normal reference range
研究组 & 干预措施
NMN Arm
NMN tablets (1000mg/tablet) , 1 tablet daily before breakfast
干预措施: NMN (Dietary Supplement)
Placebo Arm
Matching Placebo (tablets) once daily before breakfast
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
CD3+CD8+CD27-CD28- T cells as a percentage of CD3+CD8+ T cells, expressed in %, evaluated by flow cytometry
时间窗: 26 weeks
次要结局
- Waist-to-hip ratio, expressed as a unitless ratio, evaluated using a standardized tape measure following WHO measurement protocols.(26 weeks)
- Peripheral blood cell telomere length, expressed as a unitless value , evaluated by Quantitative Real-time polymerase chain reaction(26 weeks)
- Cardiorespiratory fitness related indicators, expressed in mL/kg/min, L/min, beats/min, and unitless ratios, evaluated by COSMED metabolic cart during cardiopulmonary exercise testing(26 weeks)
- Glycosylated hemoglobin, expressed in mmol/mol, evaluated by HPLC(26 weeks)
- Pancreatic β-cell function, expressed as a unitless value, evaluated by HOMA-β、HOMA-IR(26 weeks)
- Weight, expressed in kilograms, evaluated by weighing scale(26 weeks)
- Waist circumference, expressed in centimeters, evaluated by tape measure(26 weeks)
- Waist-to-hip ratio, expressed as a unitless ratio, evaluated using a standardized tape measure following WHO measurement protocols.(26 weeks)
- Waist-to-height, expressed as a unitless ratio, evaluated using a standardized tape measure following WHO measurement protocols.(26 weeks)
- NMN, NAD+ levels in peripheral blood cells, evaluated by mass spectrometry(26 weeks)
- CD3+CD8+ T cells as a percentage of CD3+CD4+ T cells, expressed in %, evaluated by flow cytometry(26 weeks)
- Body composition analysis, expressed in kg, %, and g/cm², evaluated by dual-energy X-ray absorptiometry(26 weeks)
- Determination of fasting blood glucose and OGTT 2-hour blood glucose, expressed in mmol/L, evaluated by glucose oxidase method(26 weeks)
- CD3+CD8+CD27- T cells as a percentage of total CD3+CD8+ T cells, expressed in %, evaluated by flow cytometry(26 weeks)
- CD3+CD8+CD28- T cells as a percentage of total CD3+CD8+ T cells, expressed in %, evaluated by flow cytometry(26 weeks)
- CD3+CD4+CD27- T cells as a percentage of CD3+CD4+ T cells, expressed in %, evaluated by flow cytometry(26 weeks)
- CD3+CD4+CD28- T cells as a percentage of CD3+CD4+ T cells, expressed in %, evaluated by flow cytometry(26 weeks)
- CD3+CD4+CD27-CD28- T cells as a percentage of CD3+CD4+ T cells, expressed in %, evaluated by flow cytometry(26 weeks)
- CD3+CD8+CD45RA+CCR7- T cells as a percentage of CD3+CD8+ T cells, expressed in %, evaluated by flow cytometry(26 weeks)
- CD3+CD8+CD57+KLRG1+ T cells as a percentage of CD3+CD8+ T cells, expressed in %, evaluated by flow cytometry(26 weeks)
- Body composition analysis, expressed in kg, %, and g/cm², evaluated by dual-energy X-ray absorptiometry(26 weeks)
- Determination of fasting blood glucose and OGTT 2-hour blood glucose, expressed in mmol/L, evaluated by glucose oxidase method(26 weeks)
- CD3+CD8+CD57+KLRG1+ T cells as a percentage of CD3+CD8+ T cells, expressed in %, evaluated by flow cytometry(26 weeks)
- CD3+CD8+CD27- T cells as a percentage of total CD3+CD8+ T cells, expressed in %, evaluated by flow cytometry(26 weeks)
- CD3+CD8+CD28- T cells as a percentage of total CD3+CD8+ T cells, expressed in %, evaluated by flow cytometry(26 weeks)
- CD3+CD4+CD28- T cells as a percentage of CD3+CD4+ T cells, expressed in %, evaluated by flow cytometry(26 weeks)
- CD3+CD4+CD27- T cells as a percentage of CD3+CD4+ T cells, expressed in %, evaluated by flow cytometry(26 weeks)
- CD3+CD4+CD27-CD28- T cells as a percentage of CD3+CD4+ T cells, expressed in %, evaluated by flow cytometry(26 weeks)
- CD3+CD8+CD45RA+CCR7- T cells as a percentage of CD3+CD8+ T cells, expressed in %, evaluated by flow cytometry(26 weeks)
- CD3+CD8+ T cells as a percentage of CD3+CD4+ T cells, expressed in %, evaluated by flow cytometry(26 weeks)
- NMN, NAD+ levels in peripheral blood cells, evaluated by mass spectrometry(26 weeks)
- Peripheral blood cell telomere length, expressed as a unitless value , evaluated by Quantitative Real-time polymerase chain reaction(26 weeks)
- Cardiorespiratory fitness related indicators, expressed in mL/kg/min, L/min, beats/min, and unitless ratios, evaluated by COSMED metabolic cart during cardiopulmonary exercise testing(26 weeks)
- Glycosylated hemoglobin, expressed in mmol/mol, evaluated by HPLC(26 weeks)
- Pancreatic β-cell function, expressed as a unitless value, evaluated by HOMA-β、HOMA-IR(26 weeks)
- Weight, expressed in kilograms, evaluated by weighing scale(26 weeks)
- Waist circumference, expressed in centimeters, evaluated by tape measure(26 weeks)
- Waist-to-height, expressed as a unitless ratio, evaluated using a standardized tape measure following WHO measurement protocols.(26 weeks)
研究者
Qing Su
Director, Dept of Endocrinology,Xinhua Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine