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This is a 2-part study evaluating the effects of IV administration of NR on healthy adult populations. Study 1 involved all four arms with 37 people. The second study only included the active NR and NAD+ arms to further evaluate tolerability and comfort of the IV.
The purpose of this work is to establish and quantify the safety and efficacy of IV administration of ChromaDex's Niagen®, nicotinamide riboside chloride in comparison to currently available IV NAD+, a saline IV, and orally administered Niagen®
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NR (Cohorts 1&2) | Experimental | IV administered 500 mg of sterile Niagen® (nicotinamide riboside chloride) diluted, in 500 ml of saline |
|
| Active Comparator (Cohorts 1&2) | Active Comparator | IV administered 500 mg of sterile nicotinamide adenine dinucleotide in 500 ml of saline |
|
| Oral Comparator (Cohort 1 only) | Other | orally administered 500 mg of sterile Niagen® (nicotinamide riboside chloride) in capsules |
|
| Placebo (Cohort 1 only) | Placebo Comparator | IV administered 500 ml of saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NAD+ (nicotinamide adenine dinucleotide) IV | Dietary Supplement | NAD+ enables cells to generate cellular energy from the food that one eats |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | blood pressure, systolic and diastolic, will be measured | immediately before the intervention, immediately after the intervention, 3 and 6 hours post-intervention, and at the 24 hour visit. |
| Heart rate | heart rate will be measured | immediately before the intervention, immediately after the intervention, 3 and 6 hours post-intervention, and at the 24 hour visit. |
| Total NAD measured through dried blood spot testing | NAD analysis will be developed from dried blood spots obtained by pricking a finger | Blood spot data is collected at baseline, immediately after the intervention, 3 hours after the intervention, 6 hours after the intervention,on day 2, 7, and 14. |
| Glucose | Total glucose in blood via mg/dL | baseline, at 3 hours, and 24 hours post administration of intervention |
| Insulin Levels | Total insulin in blood via mcU/mL | baseline, at 3 hours, and 24 hours post administration of intervention |
| total NAD measured through blood and plasma | NAD analysis conducted on whole blood and plasma samples | baseline, at 3 hours, and 24 hours post administration of intervention |
| Tolerable Infusion Rate | The total amount of time it takes patients to comfortably receive the IV |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Blood Count | A complete blood count with differential will be evaluated through whole blood samples | baseline, at 3 hours, and 24 hours post administration of intervention |
| Comprehensive Metabolic Panel |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Experience | Patients will be asked open ended questions to describe the experience of receiving the IV or oral intake of the assigned product. | Immediately after the intervention, 24 hours after the intervention, 7 days after the intervention, and 14 days after the intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nutraceuticals Research Institute | Franklin | Tennessee | 37067 | United States |
Patient consent does not include data sharing outside of pre-specified organizations.
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| ID | Term |
|---|---|
| D009243 | NAD |
| C018613 | nicotinamide-beta-riboside |
| ID | Term |
|---|---|
| D000227 | Adenine Nucleotides |
| D011685 | Purine Nucleotides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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|
| Niagen® (nicotinamide riboside) IV | Dietary Supplement | NR is a unique member of the vitamin B3 family. Cells can use NR to create nicotinamide adenine dinucleotide (NAD+), which is an essential molecule found in every living cell. Patients in this arm received an IV administration. |
|
| Niagen® (nicotinamide riboside) oral | Dietary Supplement | NR is a unique member of the vitamin B3 family. Cells can use NR to create nicotinamide adenine dinucleotide (NAD+), which is an essential molecule found in every living cell. Patients in this arm received an oral administration. |
|
|
| Placebo | Other | These individuals received a saline IV |
|
| through intervention completion, an average of 2 hours |
comprehensive metabolic panel will be evaluated through whole blood samples
| baseline, at 3 hours, and 24 hours post administration of intervention |
| Sleep Scale | This is a validated scale measuring 7 subdomains of sleep. It is measured on a likert scale. Scores on each subdomain can range from 5-42 with higher scores indicating greater quality of sleep | Change from baseline at day 14 |
| Energy Scale | This is a validated scale measuring 6 subdomains of energy. It is measured on a likert scale. Scores on each subdomain can range from 5 to 42, with higher scores indicating greater energy levels. | Change from baseline at day 14 |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |