Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| ChromaDex, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
This study evaluates the subjective effects of injection administration of NR on healthy adult populations.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NR via IM injection | Experimental | 100mg NR 2ml bacteriostatic water via intramuscular (IM) injection |
|
| NR via subcutaneous injection | Experimental | 100mg NR 2ml bacteriostatic water via subcutaneous (SQ) injection |
|
| NR via IV push | Experimental | 100mg NAD+ 2ml bacteriostatic water via intravenous push (IVP) injection |
|
| NAD+ via IM injection | Active Comparator | 100mg NAD+ in 2ml bacteriostatic water via intramuscular (IM) injection |
|
| NAD+ via subcutaneous injection | Active Comparator | 100mg NAD+ in 2ml bacteriostatic water via subcutaneous (SQ) injection |
|
| NAD+ via IV push | Active Comparator | 100mg NAD+ 2ml bacteriostatic water via intravenous push (IVP) injection |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Niagen® | Dietary Supplement | nicotinamide riboside |
|
| Measure | Description | Time Frame |
|---|---|---|
| McGill Pain Questionnaire | 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. | 1 minute after injection is complete |
| Subjective Discomfort | Subjective discomfort is measured using open-ended questions to qualitatively assess participant comfort during injection. | 1 minute after injection is complete |
| Measure | Description | Time Frame |
|---|---|---|
| C-reactive protein | CRP in serum | baseline, 90 minutes post injection, day 10 |
| Sed Rate | erythrocyte sedimentation rate through whole blood |
| Measure | Description | Time Frame |
|---|---|---|
| NRI Sleep Scale | The NRI Sleep scale is a validated scale that measures 6 domains of sleep via a Likert scale. Higher scores indicated greater sleep disturbances. | Baseline, Day 10 |
| NRI Energy Scale | The NRI Energy scale is a validated scale that measures 6 domains of fatigue via a Likert scale. Higher scores indicated greater fatigue. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JESSIE HAWKINS, PhD | Contact | 2562039010 | j.hawkins@nutraceuticalsresearch.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nutraceuticals Research Institute | Recruiting | Huntsville | Alabama | 35801 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C018613 | nicotinamide-beta-riboside |
| D009243 | NAD |
| ID | Term |
|---|---|
| D000227 | Adenine Nucleotides |
| D011685 | Purine Nucleotides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| placebo via IM injection | Placebo Comparator | 2ml bacteriostatic water via intramuscular (IM) injection |
|
| placebo via subcutaneous injection | Placebo Comparator | 2ml bacteriostatic water via subcutaneous (SQ) injection |
|
| placebo via IV push | Placebo Comparator | 2ml bacteriostatic water via intravenous push (IVP) injection |
|
| NAD+ | Other | Nicotinamide adenine dinucleotide |
|
| Placebo | Other | bacteriostatic water |
|
| baseline, 90 minutes post injection, day 10 |
| plasma viscosity | Plasma viscosity was measured through blood plasma. | baseline, 90 minutes post injection, day 10 |
| Baseline, Day 10 |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |