Healthy Aging
Conditions
Keywords
NAD+
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 (IVP) administration, in comparison to NAD+, an active comparator, administered through the same routes.
Interventions
Sponsors
ChromaDex, Inc.
Nutraceuticals Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| McGill Pain Questionnaire | 1 minute after injection is complete | The MPQ contains 78 pain related terms to identify the quantity and type of pain experienced. This multi-dimensional tool has three components; sensory, cognitive, emotional. Higher scores indicate higher levels of pain. |
| Subjective Discomfort | 1 minute after injection is complete | Subjective discomfort is measured using open-ended questions to qualitatively assess participant comfort during injection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| plasma viscosity | baseline, 90 minutes post injection, day 10 | Plasma viscosity was measured through blood plasma. |
| Sed Rate | baseline, 90 minutes post injection, day 10 | erythrocyte sedimentation rate through whole blood |
| C-reactive protein | baseline, 90 minutes post injection, day 10 | CRP in serum |
Other
| Measure | Time frame | Description |
|---|---|---|
| NRI Sleep Scale | Baseline, Day 10 | The NRI Sleep scale is a validated scale that measures 6 domains of sleep via a Likert scale. Higher scores indicated greater sleep disturbances. |
| NRI Energy Scale | Baseline, Day 10 | The NRI Energy scale is a validated scale that measures 6 domains of fatigue via a Likert scale. Higher scores indicated greater fatigue. |
Countries
United States
Contacts
Primary ContactJESSIE HAWKINS, PhD
Outcome results
None listed