Intervention of Nicotinamide Mononucleotide in Middle-aged and Elderly People

ConditionsAgingNMN
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age39-70
SponsorPeople's Hospital of Quzhou

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • NMN

    Dietary supplement

    NMN Arm participants took one capsule (containing 350mg NMN or placebo) with breakfast daily for one year.

  • placebo

    Dietary supplement

    Placebo arm participants took one capsule (appearance and odor are the same as NMN) with breakfast daily for one year.

Treatment groups

240 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: NMN treated (middle-aged female)Experimental treatment 1 intervention
Group B: Placebo (middle-aged male)Placebo comparator 1 intervention
Group C: NMN treated (middle-aged male)Experimental treatment 1 intervention
Group D: NMN treated (old female)Experimental treatment 1 intervention
Group E: NMN treated (old male)Experimental treatment 1 intervention
Group F: Placebo (middle-aged female)Placebo comparator 1 intervention
Group G: Placebo (old male)Placebo comparator 1 intervention
Group H: Placebo (old female)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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: 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.

Time frame
Baseline, 6 months and 12 months

Secondary outcomes

1

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: 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.

Time frame
Baseline, 6 months and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

People's Hospital of Quzhou

Lead sponsor

Beijing Institute of Genomics, Chinese Academy of Sciences

Collaborator

Institute of Zoology, Chinese Academy of Sciences

Collaborator