Nicotinamide Riboside for Endothelial Dysfunction

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Nathaniel Jenkins

Must be taking: Nicotinamide riboside

Must not be taking: Cardiovascular drugs, SSRIs

Disqualifiers: Hypertension, Obesity, Cardiovascular disease, others

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether nicotinamide riboside, a form of vitamin B3, can improve blood vessel function in young adults who had difficult childhoods. The focus is on individuals who experienced four or more adverse childhood events (ACEs), as they often face higher risks of heart problems later in life. Participants will receive either nicotinamide riboside or a placebo to determine its effect on blood vessel function. Those with four or more ACEs, without major health issues like high blood pressure or tobacco use, may be suitable for this study. As an unphased study, this trial offers a unique opportunity to contribute to understanding how nicotinamide riboside might benefit heart health in those with challenging childhoods.

Will I have to stop taking my current medications?

If you are taking cardiovascular or metabolic prescription drugs, or certain antidepressants like SSRIs or clonidine, you will need to stop as these are part of the exclusion criteria for the trial.

Is there any evidence suggesting that nicotinamide riboside is likely to be safe for humans?

Research shows that nicotinamide riboside (NR) is generally safe for use. Studies have found that NR can reduce harmful cell damage and improve blood vessel health by boosting nitric oxide levels. This is significant because harmful cell damage can impair cells, while nitric oxide enhances blood vessel function.

Reports of serious side effects with NR are rare. Most people tolerate it well, making it a promising option for improving heart and blood vessel health. Researchers are studying NR in various areas, and it is considered safe at the doses typically used in research. However, as with any supplement, individual reactions may vary, so consulting a healthcare professional before starting any new treatment is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Nicotinamide Riboside is unique because it targets endothelial dysfunction by potentially boosting levels of NAD+, a crucial molecule for cellular energy and repair. Unlike typical treatments for endothelial dysfunction, which often focus on managing symptoms with medications like statins or ACE inhibitors, Nicotinamide Riboside offers a novel approach by enhancing the body's natural repair mechanisms. Researchers are excited about this treatment because it could improve vascular health from a cellular level, offering a new way to address the root causes of the condition rather than just alleviating symptoms.

What evidence suggests that nicotinamide riboside might be an effective treatment for endothelial dysfunction?

This trial will evaluate the effects of nicotinamide riboside (NR) on endothelial dysfunction. Studies have shown that NR increases NAD+ levels in the body, which boosts SIRT1 activity. SIRT1 is linked to improved blood vessel health. Research suggests that NR might enhance blood vessel function by reducing harmful oxidative stress and increasing nitric oxide, aiding in vessel relaxation and proper function. Early findings indicate that NR can enhance mitochondrial efficiency, the energy producers in cells. These effects could potentially improve blood vessel health in individuals with difficult childhood experiences, known to impact heart health. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for young adults who have experienced at least four adverse childhood experiences (ACEs) and are showing signs of premature vascular aging, but do not yet have clinical cardiovascular disease. The study aims to include individuals both with and without ACE exposure to compare their vascular health.

Inclusion Criteria

ACE score of 0 OR ≥4 for Aim 1; ACE score ≥4 for Aim 2

I am between 18 and 30 years old.

Exclusion Criteria

Resting arterial blood pressure >140/90 mmHg

Currently pregnant or breastfeeding

Heavy alcohol consumption (AUDIT screening)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 4-week nicotinamide riboside (NR) supplementation or placebo

4 weeks

Before and after supplementation period

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nicotinamide Riboside

Trial Overview The trial is testing whether a supplement called Nicotinamide Riboside can improve blood vessel function in those affected by ACEs. It involves taking the supplement or a placebo for four weeks, with researchers measuring changes in inflammation, oxidative stress, and SIRT1 activity related to vascular health.

How Is the Trial Designed?

Group I: Nicotinamide Riboside Experimental Treatment 1 Intervention

4-weeks of twice daily, oral supplementation (2,000 mg/day) of NR (NIAGEN® , ChromaDEX, Irvine, CA).

Group II: Placebo Placebo Group 1 Intervention

Participants randomized to the control group will consume matched placebo capsules containing microcrystalline cellulose.

Who Is Running the Clinical Trial?

Nathaniel Jenkins

Lead Sponsor

Trials

5

Recruited

300+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7352172/

Nicotinamide Riboside—The Current State of Research and ... Oral supplementation with NR has been shown to increase NAD+ levels in multiple tissues, along with increased SIRT activity [10,11], improved mitochondrial ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022356525398204

Effects of NAD+ supplementation with oral nicotinamide ... Preliminary results indicate a positive trend in peripheral endothelial function, significant improvements in cerebrovascular response in the left dorsolateral ...

3. nature.com nature.com/articles/s41467-024-49092-5

Nicotinamide riboside for peripheral artery disease Oral nicotinamide riboside (NR) increases bioavailability of NAD+ in humans. Among 90 people with PAD, this randomized double-blind clinical ...

4. jpet.aspetjournals.org jpet.aspetjournals.org/article/S0022-3565(25)39820-4/abstract

Effects of NAD + supplementation with oral nicotinamide ... NAD+ supplementation with NR was associated with reduced oxidative stress and increased nitric oxide production and mitochondrial efficiency in endothelial ...

5. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.121.056589

NAD+ Metabolism in Cardiac Health, Aging, and Disease Taken together, NAD+ supplementation using nicotinamide or NR improves cardiac diastolic function through several mutually nonexclusive ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9133775/

NAD+ and Vascular Dysfunction: From Mechanisms to ... NAD+ is linked to vascular disease risk factors. Increasing NAD+ levels may reduce inflammation and improve vascular health, and is a potential ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06032923

NCT06032923 | Double-blind Placebo Controlled Study to ... Moreover, as type 1 interferon drives endothelial dysfunction, linked to increased cardiovascular risk, the effect of NR on endothelial function will be ...