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| ID | Type | Description | Link |
|---|---|---|---|
| MR-33-24-001563 | Other Identifier | Medical Research Registration and Filing Information System |
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| Name | Class |
|---|---|
| Beijing Institute of Genomics, Chinese Academy of Sciences | OTHER_GOV |
| Institute of Zoology, Chinese Academy of Sciences | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NMN treated (middle-aged female) | Experimental | NMN Arm participants (middle-aged female) took one capsule (containing 350mg NMN) with breakfast daily for one year. |
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| Placebo (middle-aged male) | Placebo Comparator | Placebo arm participants (middle-aged male) took one capsule (appearance and odor are the same as NMN) with breakfast daily for one year. |
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| NMN treated (middle-aged male) | Experimental | NMN Arm participants (middle-aged male) took one capsule (containing 350mg NMN) with breakfast daily for one year. |
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| NMN treated (old female) | Experimental | NMN Arm participants (old female) took one capsule (containing 350mg NMN) with breakfast daily for one year. |
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| NMN treated (old male) | Experimental | NMN Arm participants (old male) took one capsule (containing 350mg NMN) with breakfast daily for one year. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NMN | Dietary Supplement | NMN Arm participants took one capsule (containing 350mg NMN or placebo) with breakfast daily for one year. |
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| Measure | Description | Time Frame |
|---|---|---|
| Comprehensive evaluation of NMN in reducing biological age | 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:
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. | Baseline, 6 months and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Composite through clinical physical examination data, behavioral indicators and multilevel omics data, to discover new sensitive biomarkers for evaluating aging. | NMN intervention-associated changes will be evaluated across predefined domains:
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. |
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Inclusion criteria:
Exclusion criteria:
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:
B) older than 60 years:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feng Zhang | Contact | +86-15657053100 | felix.f.zhang@outlook.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| People's Hospital of Quzhou | Recruiting | Quzhou | Zhejiang | 324000 | China |
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| Placebo (middle-aged female) | Placebo Comparator | Placebo arm participants (middle-aged female) took one capsule (appearance and odor are the same as NMN) with breakfast daily for one year. |
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| Placebo (old male) | Placebo Comparator | Placebo arm participants (old male) took one capsule (appearance and odor are the same as NMN) with breakfast daily for one year. |
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| Placebo (old female) | Placebo Comparator | Placebo arm participants (old female) took one capsule (appearance and odor are the same as NMN) with breakfast daily for one year. |
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| placebo | Dietary Supplement | Placebo arm participants took one capsule (appearance and odor are the same as NMN) with breakfast daily for one year. |
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| Baseline, 6 months and 12 months |