Clinical trial NCT06592859: Quzhou Population Cohort Research Project (Aging Related Research: Intervention of Nicotinamide Mononucleotide in Middle-aged and Elderly People)
Official title: Quzhou Population Cohort Research Project (Aging Related Research: Intervention of Nicotinamide Mononucleotide in Middle-aged and Elderly People)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aging
Keywords: Aging
NMN
Lead sponsor: People's Hospital of Quzhou
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 240
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is a single center, randomized, double-blind, placebo-controlled clinical trial of drug intervention on aging. The purpose is to explore the effectiveness of NMN on the premise of ensuring the safety of oral drug, in order to provide effective intervention means for delaying aging and improve the quality of life of the elderly population. The main outcome measures of this study were the efficacy and safety of NMN on aging intervention.


Eligibility criteria: 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 \&gt; 1.5 mg/dl (male).
   6. poor control of hypertension (although treated, there is still significant hypertension (systolic blood pressure \&gt; 160 mmHg, or diastolic blood pressure \&gt;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\&#39;s disease, etc.
   10. nervous system diseases such as dementia, such as Alzheimer/Parkinson\&#39;s disease.
   11. diabetes mellitus (hemoglobin \&gt; 6.5% or fasting blood glucose \&gt; 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\&#39;s disease, etc.
   5. nervous system diseases such as dementia, such as Alzheimer/Parkinson\&#39;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\&#39;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.

Primary outcomes:
measure: blood NAD+ levels
timeFrame: Baseline, 6 months and 12 months
measure: SF-36 questionnaire
timeFrame: Baseline, 6 months and 12 months
Secondary outcomes:
measure: bone density
timeFrame: Baseline, 6 months and 12 months
measure: FVC
timeFrame: Baseline, 6 months and 12 months
measure: FEV1
timeFrame: Baseline, 6 months and 12 months
measure: grip strength test
timeFrame: Baseline, 6 months and 12 months
measure: flexibility of fingers
timeFrame: Baseline, 6 months and 12 months
Other outcomes:
measure: BMI
timeFrame: Baseline, 6 months and 12 months
measure: blood pressure
timeFrame: Baseline, 6 months and 12 months
measure: Changes in the body composition
timeFrame: Baseline, 6 months and 12 months
Locations:
city: Quzhou
country: China
facility: Zhejiang Province
state: Zhejiang
Study officials:
References: