Healthy Aging
Conditions
Keywords
nicotinamide adenine dinucleotide, nicotinamide riboside chloride, Niagen
Brief summary
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.
Detailed description
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®
Interventions
DIETARY_SUPPLEMENTNAD+ (nicotinamide adenine dinucleotide) IV
NAD+ enables cells to generate cellular energy from the food that one eats
DIETARY_SUPPLEMENTNiagen® (nicotinamide riboside) IV
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.
DIETARY_SUPPLEMENTNiagen® (nicotinamide riboside) oral
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.
OTHERPlacebo
These individuals received a saline IV
Sponsors
Nutraceuticals Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
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 a NRI study site * Any gender, aged 40+ (For the 5th arm, only males will be evaluated.) * Good general health as evidenced by medical history * 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, cancer, or Parkinson's disease, * Pregnancy, trying to conceive, or breastfeeding * Known allergic reactions to any components of the intervention * 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. * Introducing a new investigational drug or other intervention within 30 days before the start of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | immediately before the intervention, immediately after the intervention, 3 and 6 hours post-intervention, and at the 24 hour visit. | blood pressure, systolic and diastolic, will be measured |
| Heart rate | immediately before the intervention, immediately after the intervention, 3 and 6 hours post-intervention, and at the 24 hour visit. | heart rate will be measured |
| Total NAD measured through dried blood spot testing | 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. | NAD analysis will be developed from dried blood spots obtained by pricking a finger |
| Glucose | baseline, at 3 hours, and 24 hours post administration of intervention | Total glucose in blood via mg/dL |
| Insulin Levels | baseline, at 3 hours, and 24 hours post administration of intervention | Total insulin in blood via mcU/mL |
| total NAD measured through blood and plasma | baseline, at 3 hours, and 24 hours post administration of intervention | NAD analysis conducted on whole blood and plasma samples |
| Tolerable Infusion Rate | through intervention completion, an average of 2 hours | The total amount of time it takes patients to comfortably receive the IV |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Blood Count | baseline, at 3 hours, and 24 hours post administration of intervention | A complete blood count with differential will be evaluated through whole blood samples |
| Comprehensive Metabolic Panel | baseline, at 3 hours, and 24 hours post administration of intervention | comprehensive metabolic panel will be evaluated through whole blood samples |
| Sleep Scale | Change from baseline at day 14 | 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 |
| Energy Scale | Change from baseline at day 14 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Subjective Experience | Immediately after the intervention, 24 hours after the intervention, 7 days after the intervention, and 14 days after the intervention | Patients will be asked open ended questions to describe the experience of receiving the IV or oral intake of the assigned product. |
Countries
United States
Outcome results
None listed