Niagen®+ for Healthy Aging

Overseen By JESSIE HAWKINS, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nutraceuticals Research Institute

Must not be taking: NAD+ supplements

Disqualifiers: Seizure disorder, Diabetes, Heart disease, others

Compensation: Varies

Number of Visits: Unknown

Duration: 10 days

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the supplement Niagen®+ affects fatigue in healthy adults. Researchers are exploring various methods of administration, such as injections into the muscle, under the skin, or directly into the vein. The trial includes participants with a body mass index (BMI) between 25 and 34.9, who lead a mostly sedentary lifestyle (less than 20 minutes of exercise per day), and frequently experience tiredness. Participants must live within 100 miles of the study site and be in generally good health.

As an unphased trial, this study provides a unique opportunity to contribute to scientific understanding and potentially enhance fatigue management.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot start any new medications or supplements within 60 days before the study begins.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Niagen®, a type of nicotinamide riboside (NR), is generally safe for people. Studies have found that oral doses of NR up to 300 mg per day are usually well-tolerated, with only mild side effects such as nausea or tiredness. This suggests that similar doses given by injection might also be safe, but further research is needed to confirm this.

For NAD+, studies also suggest it is safe with few side effects. NAD+ is believed to support healthy aging and may help protect against age-related diseases. Previous research supports its safety, showing a low rate of side effects when used in supplements.

Both Niagen® and NAD+ are under study for their potential benefits in aging. While these treatments appear safe so far, monitoring new information from ongoing trials remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatments in the Niagen®+ trial for healthy aging because they explore the potential benefits of NAD+ and NR (Nicotinamide Riboside), which are precursors to NAD+, an essential molecule involved in energy production and cellular repair. Unlike traditional supplements that are taken orally, these treatments are delivered directly into the bloodstream or muscle, potentially enhancing their effectiveness and absorption. This direct delivery method could lead to faster and more significant improvements in cellular health, making them stand out from standard over-the-counter aging supplements. Additionally, by directly targeting cellular metabolism, these treatments could address aging at its root, offering a novel approach to maintaining vitality and health as we age.

What evidence suggests that this trial's treatments could be effective for healthy aging?

Research shows that nicotinamide riboside (NR) might help lower inflammation and boost metabolism, both important for aging. Studies indicate that NR can increase NAD+ levels, which tend to decrease with age. This increase might support healthy aging by improving cellular energy use. NAD+ is crucial for cell metabolism and has been linked to benefits for aging and heart health. Some studies suggest that adding NAD+ can positively impact aging markers in the body. Overall, both NR and NAD+ show promising potential for supporting healthy aging. Participants in this trial will receive either NR or NAD+ through intravenous push, intramuscular injection, or subcutaneous injection to evaluate their effects on healthy aging. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

Adults aged 40-65 with a BMI of 25-34.9, living within 100 miles of the study site, and leading a sedentary lifestyle can join this trial. They must be in good health, not use NAD+ supplements recently, and agree to lifestyle rules and contraception if applicable. Those with chronic illnesses or recent significant weight changes cannot participate.

Inclusion Criteria

Agreement to adhere to Lifestyle Considerations throughout study duration

Provision of signed and dated informed consent form

Lives within 100 miles of the NRI study site

Exclusion Criteria

Out of range phosphate levels at baseline

Positive COVID-19 test within 30 days of the study period

ANY chronic illness (pre-disease state acceptable)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive injections of NR or NAD+ via various routes to assess absorption and tolerability

10 days

Multiple visits for injections and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Niagen®+

Trial Overview The trial is testing how well the body absorbs Niagen®+, compared to NAD+, when injected into healthy adults. It looks at tolerability and subjective effects on aging-related fatigue by randomly assigning participants to receive either Niagen®, NAD+, or a placebo.

How Is the Trial Designed?

Group I: NR via subcutaneous injection Experimental Treatment 1 Intervention

100mg NR 2ml bacteriostatic water via subcutaneous (SQ) injection

Group II: NR via IV push Experimental Treatment 1 Intervention

100mg NAD+ 2ml bacteriostatic water via intravenous push (IVP) injection

Group III: NR via IM injection Experimental Treatment 1 Intervention

100mg NR 2ml bacteriostatic water via intramuscular (IM) injection

Group IV: NAD+ via IM injection Active Control 1 Intervention

100mg NAD+ in 2ml bacteriostatic water via intramuscular (IM) injection

Group V: NAD+ via subcutaneous injection Active Control 1 Intervention

100mg NAD+ in 2ml bacteriostatic water via subcutaneous (SQ) injection

Group VI: NAD+ via IV push Active Control 1 Intervention

100mg NAD+ 2ml bacteriostatic water via intravenous push (IVP) injection

Group VII: placebo via IM injection Placebo Group 1 Intervention

2ml bacteriostatic water via intramuscular (IM) injection

Group VIII: placebo via subcutaneous injection Placebo Group 1 Intervention

2ml bacteriostatic water via subcutaneous (SQ) injection

Group IX: placebo via IV push Placebo Group 1 Intervention

2ml bacteriostatic water via intravenous push (IVP) injection

Who Is Running the Clinical Trial?

Nutraceuticals Research Institute

Lead Sponsor

Trials

19

Recruited

3,700+

ChromaDex, Inc.

Industry Sponsor

Trials

8

Recruited

400+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9512238/

The Role of NAD+ in Regenerative Medicine - PMC NAD+ plays a pivotal role in cellular metabolism and is a co-substrate for enzymes that play key roles in pathways that modify aging.

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

NAD+ Metabolism in Cardiac Health, Aging, and Disease NAD + pools tend to decline with normal aging, obesity, and hypertension, which are all major risk factors for cardiovascular disease.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0006291X24001256

The therapeutic perspective of NAD + precursors in age- ... Administration of NAD+ precursors exhibit beneficial effects against aging in animal models and clinical trials. •. Involvement of microbiome is important for ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10692436/

Dietary Supplementation With NAD+-Boosting Compounds in ... The varied outcomes assessed in these studies limit comparison between trials, but together, the results suggest limited effectiveness of 12 weeks of ...

5. nature.com nature.com/articles/s41514-023-00134-0

The use of a systems approach to increase NAD + in ... Furthermore, we report a positive change in multiple healthy-ageing biomarkers (besides NAD+) in response to an NAD+ targeting supplement in a ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7277745/

Possible Adverse Effects of High-Dose Nicotinamide Counter-balancing this change through NAD+ supplementation has been proposed as beneficial for healthy aging in animal and human studies [52]. Therefore, long- ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2161831323013595

The Safety and Antiaging Effects of Nicotinamide ... NMN supplementation increases NAD + concentration and could mitigate aging-related disorders such as oxidative stress, DNA damage, neurodegeneration, and ...

8. journals.physiology.org journals.physiology.org/doi/10.1152/ajpendo.00242.2023

Evaluation of safety and effectiveness of NAD in different ... NADH supplementation is safe and has a low incidence of side effects. Future investigations are needed to evidence the clinical benefits regarding specific ...

9. verywellhealth.com verywellhealth.com/nad-supplements-7966461

What You Need to Know About NAD+ Supplements Research suggests that NAD+ (nicotinamide adenine dinucleotide) supplements may help slow the aging process, protect against neurodegenerative diseases, ...