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Safety Study of NiagenĀ®Plus for Fatigue

This study is testing the safety of NiagenĀ®Plus, an injectable form of nicotinamide riboside (NR), which is being explored for its potential to help with fatigue. Researchers want to see how safe NiagenĀ®Plus is when given by injection under the skin (subcutaneous) or into the muscle (intramuscular) at two different doses (50 mg or 100 mg). You might be able to join if you are a generally healthy adult, aged 18 or older, and experience fatigue. The main goal is to understand if NiagenĀ®Plus is safe and well-tolerated over 100 days, and how it affects NAD+ levels in the blood. The study is currently recruiting 40 participants.

Study design
This is an open-label, randomized study with 40 participants, meaning you and the researchers will know which treatment you are receiving. It has four parallel groups to evaluate NiagenĀ®Plus administered by injection.
What's involved
You would receive daily injections for the first three days in the clinic, followed by a follow-up visit on Day 10. For the rest of the study, you would self-administer injections at home three times a week until Day 100, with clinic visits on Days 40 and 100.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for safety and other assessments through Day 100, which is the final visit.

AI-generated from the public study record. Only the study team can confirm whether you're eligible ā€” confirm details with them before making decisions.

NCT07251608

Randomized, Open-label, Safety Study of Subcutaneous and Intramuscular Injections of NiagenĀ® Plus

Recruiting
PHASE1Ages 18+InterventionalTreatment
ChromaDex, Inc.
~40 participants
Updated 2025-11-26 on ClinicalTrials.gov
What's tested:NiagenĀ®Plus

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and severity of adverse events
Measured over From Day 1 (first injection) through Day 100 (final visit)
+9 more outcomes measured

Conditions

Healthy Volunteer
Fatigue

Explore related trials

FatigueHealthy Volunteer

Where it's being run

1 sites across 1 states
Florida1

Who to contact

Anne Russ, M.S.
[email protected]
13058482347
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Generally healthy adults, aged 18+
Demonstrated baseline fatigue as determined by a below average score from the FAS (threshold prespecified in SAP).
NAD+ or NAD+ precursor injection naĆÆve (including intravenous, intramuscular, subcutaneous, or other injection route) (i.e., 8 weeks abstinent)
Non-anemic
Willingness to adhere to lifestyle considerations and study procedures.
Ability to read English, and provide written informed consent.
Willingness to self-administer the study material, via subcutaneous injection for 90 days (days 10-100 of the study), and complete finger prick blood collections.

Exclusion

One or more uncontrolled chronic illness including but not limited to diabetes, cardiovascular disease, liver, disease, kidney disease, or any form of cancer. An uncontrolled chronic illness, in this case, is defined as any changes to medication or other treatment modalities in the last 90 Days.
More than one chronic disease diagnosis under active treatment.
Any chronic disease, as determined by the primary investigator, that increases risk or confounds safety.
Any acute illness within 14 Days prior to Visit 1 (Day 1).
Cancer diagnosis within the last 5 years
Anemia (as defined by hemoglobin levels below 100 g/L, and other blood measures)
Current pregnancy or lactation; unwilling to use effective contraception if of childbearing potential.
Use of any NAD+ supplement, NAD+ precursor, or vitamin B3 product, orally, nasally, by patch, or injection within the last 60 Days. NAD+ precursors and related compounds include niacin (NA), nicotinamide (NAM), nicotinamide riboside (NR), nicotinamide mononucleotide (NMN), NAD+, NADH, NAD+3, inositol hexanicotinate, apigenin; etc. The exception is the use of a daily oral multivitamin, that may contain vitamin B3 (niacin/nicotinamide). Such use will need to be documented.
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).
Any other condition rendering the participant unsuitable per investigator.
Excessive daily use of alcohol, defined as 4 or more drinks on one occasion, or illicit drug use which would prevent adherence to the protocol as determined by the investigator.

What this trial measures

  • Incidence and severity of adverse eventsFrom Day 1 (first injection) through Day 100 (final visit)

    The incidence and severity of treatment-associated moderate and severe adverse events (AEs) will be assessed.

  • Blood PressureImmediately before the first intervention, and through the 100th day of the study.

    Blood pressure, systolic and diastolic, will be measured

  • Heart RateImmediately before the intervention and through the 100th day of the study (final visit).

    Heart rate will be measured.

  • Pulse RateImmediately before and through the 100th day of the study (final visit).

    Pulse rate will be measured.

  • Respiratory RateImmediately before and through the 100th day of the study (final visit).

    Respiratory rate will be measured.

  • Blood OxygenImmediately before and through the 100th day of the study (final visit).

    Blood oxygen level will be measured.

  • Complete Blood CountImmediately before and through the 100th day of the study (final visit).

    A complete blood count with differential will be evaluated through whole blood samples

  • Comprehensive Metabolic PanelImmediately before and through the 100th day of the study (final visit).

    Comprehensive metabolic panel will be evaluated through whole blood samples

  • HomocysteineImmediately before and through the 100th day of the study (final visit).

    Homocysteine will be measured from venous blood samples as part of the primary safety laboratory panel. Levels will be analyzed as absolute values and change-from-baseline to evaluate any clinically significant elevations or shifts associated with repeat dosing of NiagenĀ®Plus.

  • High-Sensitivity C-Reactive Protein (hs-CRP)Immediately before and through the 100th day of the study (final visit).

    High-sensitivity C-reactive protein will be assessed from venous blood samples as part of the primary safety laboratory panel. hs-CRP is a sensitive biomarker of systemic inflammation and may signal acute or sub-acute inflammatory responses to repeated NiagenĀ®Plus dosing. Levels will be analyzed as absolute values and change-from-baseline to identify any clinically meaningful elevations or trends. Data will be summarized descriptively by dose and route of administration to support safety evaluation.