Niagen®Plus for Fatigue

Overseen By Anne Russ, M.S.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: ChromaDex, Inc.

Must not be taking: NAD+ supplements

Disqualifiers: Uncontrolled chronic illness, Cancer, Anemia, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Niagen®Plus, an injectable form of nicotinamide riboside (a type of vitamin B3), is safe and how it affects energy levels in the body. Researchers will assess changes in fatigue, sleep, and overall quality of life over 100 days. Participants will receive injections either under the skin or into the muscle, with some administering the treatment at home. The trial seeks generally healthy adults who often feel tired and have not recently used NAD+ supplements or related products. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have an uncontrolled chronic illness with recent medication changes, you may not be eligible to participate.

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

Research has shown that Niagen®Plus, an injectable form of nicotinamide riboside (NR), has generally been safe in past studies. One study found that administering 500 mg of NR through an IV was safe, with no major safety issues reported. Niagen® is also considered safe for use in food, supporting its safety profile.

However, limited information exists about the injectable form used in this trial. Additionally, NAD+ injections are not recommended for pregnant or breastfeeding individuals due to insufficient safety data. While studies suggest Niagen®Plus is well-tolerated, this trial aims to provide more information about the safety of its injectable form. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Niagen®Plus for treating fatigue because it offers a unique approach compared to current options like stimulants or lifestyle changes. Niagen®Plus works by potentially enhancing cellular energy production, targeting fatigue at a cellular level rather than just masking symptoms. This treatment is distinctive due to its varied delivery methods, which include both subcutaneous and intramuscular injections. These methods might allow for more precise dosing and targeted delivery, potentially leading to quicker results or improved efficacy. Additionally, the use of different dosages and administration schedules could cater to varying needs and responses among patients.

What evidence suggests that Niagen®Plus could be an effective treatment for fatigue?

Studies have shown that nicotinamide riboside (NR), a type of vitamin B3, can increase NAD+ levels in the body. NAD+ plays a crucial role in energy production and cell repair. Research suggests that NR supplements may help reduce tiredness and improve sleep, particularly for individuals with long COVID symptoms. One study found that NADH, a similar compound, reduced fatigue in people with chronic fatigue syndrome. These findings suggest that increasing NAD+ levels with Niagen®Plus, administered in various dosages and methods to trial participants, might help reduce tiredness and enhance well-being. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for generally healthy adults interested in the safety of Niagen®Plus, an injectable form of nicotinamide riboside. Participants will be involved for about 100 days, receiving injections and completing surveys on fatigue, sleep, and well-being.

Inclusion Criteria

Ability to read English, and provide written informed consent

Demonstrated baseline fatigue as determined by a below average score from the FAS (threshold prespecified in SAP)

Non-anemic

Exclusion Criteria

Hypersensitivity or allergy to NR, niacin, other forms of vitamin B3/NAD+ precursors, bacteriostatic water

Significant aversion to needles or finger pricks

Participation in another clinical intervention study, 90 Days (or 5 half-lives of the intervention, whichever is longer) prior to Visit 1 (Day 1)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants receive three consecutive daily injections of Niagen®Plus (50 mg or 100 mg; subcutaneous or intramuscular) administered in clinic on Days 1-3

1 week

3 visits (in-person)

Follow-up Visit

Participants return for a follow-up visit on Day 10 for safety evaluation and laboratory testing

1 day

1 visit (in-person)

Continued Treatment

Participants self-administer subcutaneous Niagen®Plus at home three times per week from Days 10-100

13 weeks

2 visits (in-person) on Days 40 and 100

Final Follow-up

Participants return to the clinic on Day 100 for final safety and laboratory testing

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Niagen®Plus

Trial Overview The study tests the safety and effects of Niagen®Plus injections on NAD+ blood levels over 100 days. It involves initial clinic injections followed by self-injections at home, with clinic visits for testing and monitoring changes in various health aspects.

How Is the Trial Designed?

Group I: 50 mg Subcutaneous Niagen®Plus Experimental Treatment 1 Intervention

Participants receive 50 mg Niagen®Plus administered subcutaneously (under the skin) once daily for three consecutive days during in-clinic visits (Days 1-3). Participants then continue self-administered subcutaneous injections of the same dose three times per week (Monday, Wednesday, Friday) from Days 10-100.

Group II: 50 mg Intramuscular Niagen®Plus Experimental Treatment 1 Intervention

Participants receive 50 mg Niagen®Plus administered intramuscularly (into the deltoid muscle) once daily for three consecutive days during in-clinic visits (Days 1-3). No further at-home injections are performed; participants return for follow-up visits on Days 10, 40, and 100.

Group III: 100 mg Subcutaneous Niagen®Plus Experimental Treatment 1 Intervention

Participants receive 100 mg Niagen®Plus administered subcutaneously once daily for three consecutive days during in-clinic visits (Days 1-3). Participants then continue self-administered subcutaneous injections of the same dose three times per week (Monday, Wednesday, Friday) from Days 10-100.

Group IV: 100 mg Intramuscular Niagen®Plus Experimental Treatment 1 Intervention

Participants receive 100 mg Niagen®Plus administered intramuscularly (into the deltoid muscle) once daily for three consecutive days during in-clinic visits (Days 1-3). No further at-home injections are performed; participants return for follow-up visits on Days 10, 40, and 100.

Who Is Running the Clinical Trial?

ChromaDex, Inc.

Lead Sponsor

Trials

8

Recruited

400+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07251608

Randomized, Open-label, Safety Study of Subcutaneous ... Participants receive 100 mg Niagen®Plus administered intramuscularly (into the deltoid muscle) once daily for three consecutive days during in- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9495723/

Current Uncertainties and Future Challenges Regarding ... Most side effects reported during NAM, NR, and NMN administration are minor (e.g., diarrhea, nausea, rashes, flushing, calf cramps, thrombocytopenia, erythema ...

3. medrxiv.org medrxiv.org/content/10.1101/2024.06.06.24308565v1.full-text

Randomized, placebo-controlled, pilot clinical study ... This is the first study to clinically evaluate NR IV. Overall, acute intravenous infusions of 500 mg NR were safe in the study participants with no ...

4. journals.physiology.org journals.physiology.org/doi/full/10.1152/ajpendo.00242.2023

Evaluation of safety and effectiveness of NAD in different ... (23) observed NADH may be a valuable adjunctive therapy in the management of chronic fatigue syndrome. This response was characterized by improvement in fatigue ...

5. morningstar.com morningstar.com/news/business-wire/20251112992378/niagen-bioscience-announces-results-from-first-ever-randomized-controlled-trial-exploring-niagen-patented-nicotinamide-riboside-nr-supplementation-in-long-covid

Niagen Bioscience Announces Results from First-Ever ... “These findings demonstrate that ten weeks of Niagen NR supplementation increased NAD+ levels and improved long COVID symptoms of fatigue, sleep ...

6. empowerpharmacy.com empowerpharmacy.com/compounding-pharmacy/nad-injection/

NAD+ Injection (Lyo) In summary, due to insufficient safety data, NAD+ Injection is contraindicated in pregnancy and during breastfeeding to protect both mother and child.

7. niagenplus.com niagenplus.com/blogs/blog/safety-first-understanding-the-importance-of-pharmaceutical-grade-nad-in-iv-therapy

Safety First: Why Pharmaceutical-Grade NAD+ IV Therapy ... Learn why the FDA warns against food-grade NAD+ IVs and how Niagen Plus's pharmaceutical-grade Niagen IV (NRC) offers a safer, ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6611812/

Safety and Metabolism of Long-term Administration of ... NIAGEN is Generally Recognized as Safe (GRAS) in the United States for use in food products and the subject of two new dietary ingredient ...