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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NMN Arm | Experimental | NMN tablets (1000mg/tablet) , 1 tablet daily before breakfast |
|
| Placebo Arm | Placebo Comparator | Matching Placebo (tablets) once daily before breakfast |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NMN | Dietary Supplement | NMN SR tablets(1000mg/tablets) , 1 tablet daily before breakfast |
| |
| Measure | Description | Time Frame |
|---|---|---|
| CD3+CD8+CD27-CD28- T cells as a percentage of CD3+CD8+ T cells, expressed in %, evaluated by flow cytometry | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Su | Contact | 008613651611560 | suqing139@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | China |
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| Placebo |
| Dietary Supplement |
Matching Placebo (tablets) once daily before breakfast |
|
| 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 |
| 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-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 |