Status:
RECRUITING
Absorption and Tolerability of Injectable Administration of Niagen®+, as Compared to NAD+
Lead Sponsor:
Nutraceuticals Research Institute
Collaborating Sponsors:
ChromaDex, Inc.
Conditions:
Healthy Aging
Eligibility:
All Genders
40-65 years
Phase:
NA
Brief Summary
This study evaluates the subjective effects of injection administration of NR on healthy adult populations.
Detailed Description
The purpose of this work is to explore the tolerability of Niagen®, nicotinamide riboside chloride, a specialized form of vitamin B3, via intramuscular (IM), subcutaneous (SQ), and intravenous-push (I...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06919328
Start Date
October 31 2024
End Date
June 30 2025
Last Update
April 9 2025
Active Locations (1)
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1
Nutraceuticals Research Institute
Huntsville, Alabama, United States, 35801