NAD, Vascular Aging
Conditions
Brief summary
Emerging evidence identifies vascular aging independently predicting cardiovascular events, yet effective clinical interventions remain lacking. Nicotinamide adenine dinucleotide (NAD+) is an essential cofactor whose levels decline with age, and preclinical studies suggest that boosting NAD+ can improve vascular function and structure. Preliminary clinical studies in healthy older adults indicate that supplementation with NAD+ precursors, such as nicotinamide riboside(NR) or nicotinamide mononucleotide (NMN), can reduce arterial stiffness as measured by pulse wave velocity (PWV). However, whether NAD+ supplementation can improve vascular endothelial function and exert anti-stiffening effects in patients who have already developed measurable arterial stiffness remains unknown. Based on this evidence, the investigator hypothesize that the Coenzyme I for Injection will reverse vascular aging in older adults with established arterial stiffening.
Interventions
DRUGNaCl (placebo)
Subjects receive 7 consecutive days of intravenous infusion of NaCl(0.9%).
Subjects receive 7 consecutive days of intravenous infusion of Coenzyme I for injection.
Sponsors
Shanghai 10th People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Ages 40-70 years; 2. cf-PWV was abnormally elevated and above the upper limit of its age-and blood-pressure matched reference range; 3. Systolic Blood Pressure \< 160 mmHg and ≥ 140 mmHg or Diastolic BP \< 100 mmHg ≥ 90mmHg; 4. Signed informed consent.
Exclusion criteria
1. Consumption of foods or medications containing high levels of NAD+, NR, NAM, NMN, or niacin-related components (including Vitamin B3 and natural health products) within 3 months prior to screening； 2. History of major cardiovascular or cerebrovascular events, including myocardial infarction, angina, stroke, or hospitalization for arterial revascularization； 3. Systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg； 4. Diagnosis of malignant tumor； 5. Known allergy or history of severe adverse reactions to Coenzyme I injection or any of its components； 6. History of severe allergies or infusion reactions； 7. Women who are pregnant, breastfeeding, or planning pregnancy； 8. Severe hepatic or renal dysfunction: ALT or AST \> 5 times the upper limit of normal; glomerular filtration rate ≤ 30 mL/min/1.73 m²； 9. Concurrent participation in another clinical trial without completion of the follow-up period； 10. Other conditions deemed by the investigator as unsuitable for inclusion, such as psychiatric or psychological disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in flow-mediated vasodilation(FMD) | Day 8/28 | Changes in FMD from baseline to day 8/28. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in retinal arteriovenous ratio (AVR) and wall/lumen ratio (WLR) | day 8/28 | Changes in retinal arteriovenous ratio (AVR) and wall/lumen ratio (WLR) from baseline to day 8/28. |
| Changes in the level of NAD+ | day 8/28 | Changes in the level of NAD+ from baseline to day 8/28. |
| Changes in cf-PWV. | day 8/28 | Changes in cf-PWV from baseline to day 8/28. |
| Changes in office blood pressure and 24-hour ambulatory blood pressure | day 8/28 | Changes in office blood pressure and 24-hour ambulatory blood pressure from baseline to day 8/28. |
| The change in the urine albumin-to-creatinine ratio | day 8/28 | The change in the urine albumin-to-creatinine ratio from baseline to day 8/28. |
| Changes in the metabolomics. | day 8/28 | Changes in the metabolomics from baseline to day 8/28. |
Countries
China
Contacts
Primary ContactYi Zhang
Outcome results
None listed