Actively Recruiting
Absorption and Tolerability of Injectable Administration of Niagen®, Nicotinamide Riboside Chloride, a Specialized Form of Vitamin B3, as Compared to NAD+: a Double Blinded, Randomized, Controlled Clinical Trial
Led by Nutraceuticals Research Institute · Updated on 2025-04-09
70
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
N
Nutraceuticals Research Institute
Lead Sponsor
C
ChromaDex, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the subjective effects and tolerability of Niagen®, a specialized form of vitamin B3 called nicotinamide riboside chloride, administered by injection in healthy adults aged 40 to 65. The study compares Niagen® with NAD+, an active comparator, using the same injection routes. The goal is to understand how these substances are absorbed and tolerated when given by different injection methods. Participants receive either 100mg of Niagen® or NAD+ dissolved in 2ml of bacteriostatic water, administered via intramuscular (IM), subcutaneous (SQ), or intravenous push (IVP) injection. There are also placebo groups receiving just bacteriostatic water through the same injection methods. The study is randomized and double-blinded to compare the effects across these groups. During the study, participants will be monitored closely with assessments including pain and discomfort questionnaires one minute after injections. Blood tests for inflammation markers such as C-reactive protein, sedimentation rate, and plasma viscosity will be taken at baseline, 90 minutes post-injection, and on day 10. The study lasts for the duration needed to complete these assessments, with safety and tolerability as key focus points.
CONDITIONS
Brief Title
Absorption and Tolerability of Injectable Administration of Niagen®+, as Compared to NAD+
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provision of signed and dated informed consent form
- Willingness and ability to comply with all study procedures and availability for the study duration
- Lives within 100 miles of the study site
- Any gender, aged 40 to 65 years inclusive
- Good general health based on medical history
- Body mass index (BMI) between 25 and 34.9 kg/m2
- Sedentary lifestyle with less than 20 minutes per day or 100 minutes per week of moderate to vigorous exercise
- Demonstrated fatigue with a below-average score on the Fatigue Assessment Scale
- For females of reproductive potential, use of highly effective contraception for at least 1 month prior to screening and agreement to use it during and one month after the study
- Agreement to follow lifestyle considerations throughout the study
You will not qualify if you...
- Current diagnosis of seizure disorder, diabetes, insulin resistance, kidney or liver disorder, heart disease, anemia, cancer, or Parkinson's disease
- Any chronic illness (except pre-disease states)
- Abnormal phosphate levels at baseline
- BMI less than 25 or 35 and above
- Pregnancy, trying to conceive, or breastfeeding
- Known allergy to any study components or related compounds including vitamin B3
- Positive COVID-19 test within 30 days prior to the study
- Significant weight change (10% body weight) in the last 6 months
- Current use of NAD+ or NAD precursors, including B-complex supplements, within 60 days before the study (multivitamins excluded)
- Starting any new medication, supplement, investigational drug, or lifestyle change within 60 days before the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single administration with assessments up to 10 days
Participants receive injections of Niagen®, NAD+, or placebo via intramuscular, subcutaneous, or intravenous push routes to assess absorption and tolerability.
1 injection visit and 2 follow-up visits (90 minutes post injection and day 10)
Trial Site Locations
Total: 1 location
1
Nutraceuticals Research Institute
Huntsville, Alabama, United States, 35801
Actively Recruiting
Research Team
J
JESSIE HAWKINS, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
9
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