Actively Recruiting
Randomized, Open-label, Safety Study of Subcutaneous and Intramuscular Injections of Niagen® Plus
Led by ChromaDex, Inc. · Updated on 2025-11-26
40
Participants Needed
1
Research Sites
19 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this study is to learn about the safety of Niagen®Plus, an injectable form of nicotinamide riboside (NR), and to see how it affects levels of NAD+ in the blood. Niagen®Plus will be given either by subcutaneous (under the skin) or intramuscular (into the muscle) injection at two dose levels (50 mg or 100 mg). The main questions this study aims to answer are: Is Niagen®Plus safe and well-tolerated when given by injection several times over 100 days? How do NAD+ levels in blood change after repeated doses of Niagen®Plus? What are participants' and clinicians' experiences with the injections? Researchers will also look at changes in fatigue, sleep, quality of life, inflammation markers, mitochondrial efficiency, and perceived skin appearance. Participants will: Receive three injections in clinic on Days 1-3, followed by a Day 10 follow-up visit Self-inject Niagen®Plus at home three times per week from Days 10-100 Return to the clinic on Days 40 and 100 for safety and laboratory testing Complete short surveys about fatigue, sleep, and overall well-being throughout the study The study will include 40 generally healthy adults and will last about 100 days per participant.
CONDITIONS
Official Title
Randomized, Open-label, Safety Study of Subcutaneous and Intramuscular Injections of Niagen® Plus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Generally healthy adults aged 18 years or older
- Demonstrated baseline fatigue with below average fatigue assessment scale scores
- No NAD+ or NAD+ precursor injections within the prior 8 weeks
- Non-anemic participants
- Willing to follow lifestyle guidelines and study procedures
- Ability to read English and provide written informed consent
- Willingness to self-inject subcutaneous Niagen4 Plus from Days 10 to 100 and complete finger prick blood samples
You will not qualify if you...
- Uncontrolled chronic illnesses such as diabetes, cardiovascular disease, liver disease, kidney disease, or any cancer with medication or treatment changes in the last 90 days
- More than one chronic disease under active treatment
- Any chronic disease increasing risk or confounding safety as judged by the investigator
- Any acute illness within 14 days before Day 1
- Cancer diagnosis within the past 5 years
- Anemia defined by hemoglobin below 100 g/L or other blood abnormalities
- Current pregnancy or lactation; or unwillingness to use effective contraception if of childbearing potential
- Use of NAD+ supplements or precursors by any route in the past 60 days, except daily multivitamins containing vitamin B3
- Allergy or hypersensitivity to NR, niacin, vitamin B3 forms, or bacteriostatic water
- Strong aversion to needles or finger pricks
- Participation in another clinical intervention study within 90 days or 5 half-lives of that intervention
- Any condition making the participant unsuitable as per investigator
- Excessive alcohol use (4 or more drinks on one occasion) or illicit drug use preventing study adherence
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
BTT Medical Institute Aventura North
Miami, Florida, United States, 33180
Actively Recruiting
Research Team
A
Anne Russ, M.S.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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