Clinical trial NCT06382688: IV Administration of ChromaDex's Niagen® as Compared to NAD+
Official title: The Effects of IV Administration of ChromaDex's Niagen®, Nicotinamide Riboside Chloride as Compared to IV Administration of NAD+: A Randomized, Placebo Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy Aging
Keywords: nicotinamide adenine dinucleotide
nicotinamide riboside chloride
Niagen
Lead sponsor: Nutraceuticals Research Institute
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 53
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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®

Eligibility criteria: 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

Primary outcomes:
measure: Blood Pressure
timeFrame: immediately before the intervention, immediately after the intervention, 3 and 6 hours post-intervention, and at the 24 hour visit.
measure: Heart rate
timeFrame: immediately before the intervention, immediately after the intervention, 3 and 6 hours post-intervention, and at the 24 hour visit.
measure: Total NAD measured through dried blood spot testing
timeFrame: 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.
measure: Glucose
timeFrame: baseline, at 3 hours, and 24 hours post administration of intervention
measure: Insulin Levels
timeFrame: baseline, at 3 hours, and 24 hours post administration of intervention
measure: total NAD measured through blood and plasma
timeFrame: baseline, at 3 hours, and 24 hours post administration of intervention
measure: Tolerable Infusion Rate
timeFrame: through intervention completion, an average of 2 hours
Secondary outcomes:
measure: Complete Blood Count
timeFrame: baseline, at 3 hours, and 24 hours post administration of intervention
measure: Comprehensive Metabolic Panel
timeFrame: baseline, at 3 hours, and 24 hours post administration of intervention
measure: Sleep Scale
timeFrame: Change from baseline at day 14
measure: Energy Scale
timeFrame: Change from baseline at day 14
Other outcomes:
measure: Subjective Experience
timeFrame: Immediately after the intervention, 24 hours after the intervention, 7 days after the intervention, and 14 days after the intervention
Locations:
city: Franklin
country: United States
facility: Nutraceuticals Research Institute
state: Tennessee
Study officials:
References: