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NCT Number: NCT06592859

Intervention of Nicotinamide Mononucleotide in Middle-aged and Elderly People

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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Key information

Conditions

Age range

39 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

People's Hospital of Quzhou

Quzhou, Zhejiang, 324000, China

Location status: Recruiting

Location contact

Beier Jiang

CONTACT

[email protected]

+86-18367091390

Feng Zhang, Professor

PRINCIPAL_INVESTIGATOR

Guanghui Liu, Professor

SUB_INVESTIGATOR

Weiqi Zhang, Professor

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Be able to communicate well with researchers and cooperate with the work during the study.
  • Written informed consent can be signed voluntarily.

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:

  • any cancer (erythrocytosis, except basal cell or squamous cell skin cancer).
  • coronary artery disease/myocardial infarction/clinically significant congestive heart failure.
  • stroke/transient ischemic attack.
  • deep vein thrombosis/pulmonary embolism.
  • serum creatinine > 1.5 mg/dl (male).
  • poor control of hypertension (although treated, there is still significant hypertension (systolic blood pressure > 160 mmHg, or diastolic blood pressure >100 mmHg)).
  • history of active liver disease or metabolic acidosis.
  • chronic kidney disease/hemodialysis treatment, history of severe kidney damage and/or EGFR ≤ 45ml/min/1.73m2.
  • severe autoimmunity/inflammation, such as rheumatoid arthritis, lupus, Crohn's disease, etc.
  • nervous system diseases such as dementia, such as Alzheimer/Parkinson's disease.
  • diabetes mellitus (hemoglobin > 6.5% or fasting blood glucose > 126 mg/dL or taking diabetes drugs or insulin treatment).
  • recent (within 3 months) cardiovascular events (myocardial infarction, coronary intervention, coronary artery bypass grafting).
  • infectious diseases such as HIV, hepatitis, tuberculosis, etc.
  • hand or lower limb disability affects normal function and life.

B) older than 60 years:

  • any cancer (erythrocytosis, except basal cell or squamous cell skin cancer).
  • history of active liver disease or metabolic acidosis.
  • chronic kidney disease/hemodialysis treatment, history of severe kidney damage and/or EGFR ≤ 45ml/min/1.73m2.
  • severe autoimmunity/inflammation, such as lupus, Crohn's disease, etc.
  • nervous system diseases such as dementia, such as Alzheimer/Parkinson's disease.
  • recent (within 3 months) cardiovascular events (myocardial infarction, coronary intervention, coronary artery bypass grafting).
  • infectious diseases such as HIV, hepatitis, tuberculosis, etc.
  • hand or lower limb disability affects normal function and life.
  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Comprehensive evaluation of NMN in reducing biological age

    Time frame: 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:

    • Transcriptomic age (years)
    • DNA methylation age (years)
    • Proteomic age (years)
    • Metabolomic age (years)
    • 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 outcomes

  1. Composite through clinical physical examination data, behavioral indicators and multilevel omics data, to discover new sensitive biomarkers for evaluating aging.

    Time frame: Baseline, 6 months and 12 months

    NMN intervention-associated changes will be evaluated across predefined domains:

    • Clinical examination parameters, such as:
    • Bone mineral density (g/cm²)
    • Pulmonary function, including FEV1 (L), FVC (L), and FEV1/FVC (%) Each parameter will be analyzed individually.
    • Functional performance measures, such as:
    • Grip strength (kg)
    • Purdue Pegboard Test completion time (s) Improvement is defined as an increase in grip strength and a decrease in completion time.
    • 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.

    • 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Feng Zhang

CONTACT

[email protected]

+86-15657053100

Sponsors and collaborators

Lead sponsor

People's Hospital of Quzhou

Other

Collaborators

  • Beijing Institute of Genomics, Chinese Academy of Sciences
  • Institute of Zoology, Chinese Academy of Sciences

Registry information

Official study title

Quzhou Population Cohort Research Project (Aging Related Research: Intervention of Nicotinamide Mononucleotide in Middle-aged and Elderly People)

Acronym: NMNAGING

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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