Aging, NMN
Conditions
Keywords
Aging, NMN
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTNMN
NMN Arm participants took one capsule (containing 350mg NMN or placebo) with breakfast daily for one year.
DIETARY_SUPPLEMENTplacebo
Placebo arm participants took one capsule (appearance and odor are the same as NMN) with breakfast daily for one year.
Sponsors
People's Hospital of Quzhou
Beijing Institute of Genomics, Chinese Academy of Sciences
Institute of Zoology, Chinese Academy of Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
39 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
： 1. Local residents of Quzhou or living in Quzhou for over ten years. 2. age 40-50 and 60-70 years old, no major bad habits. 3. Gender unlimited. 4. in good health and has not undergone major surgery within half a year. 5. Be able to communicate well with researchers and cooperate with the work during the study. 6. Written informed consent can be signed voluntarily.
Exclusion criteria
： 1. Alcoholism, heavy smoking (more than 5 packs/day, 20 cigarettes per pack), drug abuse or substance abuse. 2. 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.). 3. Obesity (bmi more than 30). 4. Pregnant/lactating women. 5. Disease history: A) under 60 years old: 1. any cancer (erythrocytosis, except basal cell or squamous cell skin cancer). 2. coronary artery disease/myocardial infarction/clinically significant congestive heart failure. 3. stroke/transient ischemic attack. 4. deep vein thrombosis/pulmonary embolism. 5. serum creatinine \> 1.5 mg/dl (male). 6. poor control of hypertension (although treated, there is still significant hypertension (systolic blood pressure \> 160 mmHg, or diastolic blood pressure \>100 mmHg)). 7. history of active liver disease or metabolic acidosis. 8. chronic kidney disease/hemodialysis treatment, history of severe kidney damage and/or EGFR ≤ 45ml/min/1.73m2. 9. severe autoimmunity/inflammation, such as rheumatoid arthritis, lupus, Crohn\'s disease, etc. 10. nervous system diseases such as dementia, such as Alzheimer/Parkinson\'s disease. 11. diabetes mellitus (hemoglobin \> 6.5% or fasting blood glucose \> 126 mg/dL or taking diabetes drugs or insulin treatment). 12. recent (within 3 months) cardiovascular events (myocardial infarction, coronary intervention, coronary artery bypass grafting). 13. infectious diseases such as HIV, hepatitis, tuberculosis, etc. 14. hand or lower limb disability affects normal function and life. B) older than 60 years: 1. any cancer (erythrocytosis, except basal cell or squamous cell skin cancer). 2. history of active liver disease or metabolic acidosis. 3. chronic kidney disease/hemodialysis treatment, history of severe kidney damage and/or EGFR ≤ 45ml/min/1.73m2. 4. severe autoimmunity/inflammation, such as lupus, Crohn\'s disease, etc. 5. nervous system diseases such as dementia, such as Alzheimer/Parkinson\'s disease. 6. recent (within 3 months) cardiovascular events (myocardial infarction, coronary intervention, coronary artery bypass grafting). 7. infectious diseases such as HIV, hepatitis, tuberculosis, etc. 8. hand or lower limb disability affects normal function and life. 6. 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). 7. The researchers believe that the physical factors of the participants may have an adverse impact on the research process or results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comprehensive evaluation of NMN in reducing biological age | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | NMN intervention-associated changes will be evaluated across predefined domains: 1. Clinical examination parameters, such as: 1. Bone mineral density (g/cm²) 2. Pulmonary function, including FEV1 (L), FVC (L), and FEV1/FVC (%) Each parameter will be analyzed individually. 2. Functional performance measures, such as: 1. Grip strength (kg) 2. Purdue Pegboard Test completion time (s) Improvement is defined as an increase in grip strength and a decrease in completion time. 3. Inflammatory and clinical biomarkers, such as: Circulating inflammatory markers (e.g., IL-6 \[pg/mL\], CRP \[mg/L\]) Improvement is defined as a reduction in these markers. 4. Multi-omics-derived aging biomarkers, such as: Gene expression, proteomic, and metabolomic profiles related to metabolism, immunity, and aging. These measures will be summarized using: Predefined composite aging scoresm, biological ages, or principal component-based or pathway-level summaries, depending on the analysis framework. |
Countries
China
Contacts
CONTACTFeng Zhang
Outcome results
None listed