Health TrialsbyHealthPanel

Efficacy and Safety of Coenzyme I for Injection on Vascular Aging.

ConditionsVascular AgingNAD
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-70
SponsorShanghai 10th People's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ages 40-70 years;

cf-PWV was abnormally elevated and above the upper limit of its age-and blood-pressure matched reference range;

Systolic Blood Pressure < 160 mmHg and ≥ 140 mmHg or Diastolic BP < 100 mmHg ≥ 90mmHg;

Signed informed consent.

Disqualifiers

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；

History of major cardiovascular or cerebrovascular events, including myocardial infarction, angina, stroke, or hospitalization for arterial revascularization；

Systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg；

Diagnosis of malignant tumor；

Trial design

Design model

Parallel

Treatments tested in this trial

  • Coenzyme I for Injection

    Drug

    Subjects receive 7 consecutive days of intravenous infusion of Coenzyme I for injection.

  • NaCl (placebo)

    Drug

    Subjects receive 7 consecutive days of intravenous infusion of NaCl(0.9%).

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The change in flow-mediated vasodilation(FMD)

Changes in FMD from baseline to day 8/28.

Time frame
Day 8/28

Secondary outcomes

1

Changes in cf-PWV.

Changes in cf-PWV from baseline to day 8/28.

Time frame
day 8/28
2

Changes in retinal arteriovenous ratio (AVR) and wall/lumen ratio (WLR)

Changes in retinal arteriovenous ratio (AVR) and wall/lumen ratio (WLR) from baseline to day 8/28.

Time frame
day 8/28
3

Changes in the level of NAD+

Changes in the level of NAD+ from baseline to day 8/28.

Time frame
day 8/28
4

Changes in the metabolomics.

Changes in the metabolomics from baseline to day 8/28.

Time frame
day 8/28

Other outcomes

Sponsors and contacts

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

Shanghai 10th People's Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: