Evaluating the effects of injectable Niagen®+ compared to NAD+ for healthy aging
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
This study is testing if an injectable form of vitamin B3 called Niagen®+ is safe and effective for healthy aging compared to another treatment called NAD+ in healthy adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 40 Years to 65 Years |
| Sex | All |
| Sponsor | Nutraceuticals Research Institute Academic / other |
| Locations | 1 site (Huntsville, Alabama) |
| Trial ID | NCT06919328 on ClinicalTrials.gov |
What this trial studies
This study investigates the tolerability and subjective effects of Niagen®, a specialized form of vitamin B3, administered through intramuscular, subcutaneous, and intravenous-push routes in healthy adults. It compares these effects to those of NAD+, an active comparator, using the same administration methods. Participants will be monitored for their responses to the injections to determine the safety and acceptability of Niagen®+. The study aims to gather data that could inform future applications of NAD+ precursors in promoting healthy aging.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 40-65 with a BMI of 25-34.9 and a sedentary lifestyle.
Not a fit: Patients with current diagnoses of seizure disorders, diabetes, or significant kidney or liver issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into effective methods for enhancing healthy aging through improved NAD+ levels.
How similar studies have performed: While the specific administration of Niagen®+ is novel, similar studies on NAD+ precursors have shown promising results in enhancing health outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness and demonstrated ability to comply with all study procedures, as well as availability for the duration of the study * Lives within 100 miles of the NRI study site * Any gender, aged 40-65, inclusive * Good general health as evidenced by medical history * BMI 25-34.9 kg/m2 * Sedentary behavior (defined as \<20 minutes per day or 100 minutes per week of moderate to vigorous exercise) * Demonstrated fatigue (Fatigue Assessment Scale) defined as a below-average score * For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional month after the end of the study * Agreement to adhere to Lifestyle Considerations throughout study duration Exclusion Criteria: * Current diagnosis of any seizure disorder, diabetes or insulin resistance, any kidney or liver disorder, heart disease, anemia, cancer, or Parkinson's disease * ANY chronic illness (pre-disease state acceptable) * Out of range phosphate levels at baseline * BMI less than 25 or greater than or equal to 35 * Pregnancy, trying to conceive, or breastfeeding * Known allergic reactions to any components of the intervention or related compounds, including any form of B3 * Positive COVID-19 test within 30 days of the study period * Recent dramatic weight changes (10% change in body weight in the last 6 months) * Existing usage of a NAD+ or NAD precursor supplement in any form (oral, nasal, patch, or injection/IV administration), including a B-complex supplement, within 60 days of the study, not including multivitamins. * Introducing a new medication, supplement, investigational drug, or other intervention (including lifestyle changes) within 60 days of the start of the study.
Where this trial is running
Huntsville, Alabama
- Nutraceuticals Research Institute — Huntsville, Alabama, United States (Recruiting)
Study contacts
- Study coordinator: JESSIE HAWKINS, PhD
- Email: j.hawkins@nutraceuticalsresearch.com
- Phone: 2562039010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.