IV Administration of ChromaDex's Niagen® as Compared to NAD+

Healthy Aging Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06382688
• Other study ID #: 23-08-0010
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 13, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: April 2024
• Source: Franklin Health Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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®

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 53
• Est. completion date: August 31, 2024
• Est. primary completion date: March 8, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Aging

Intervention

Dietary Supplement:
• NAD+ (nicotinamide adenine dinucleotide) IV
NAD+ enables cells to generate cellular energy from the food that one eats
• Niagen® (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.
• Niagen® (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.

Other:
• Placebo
These individuals received a saline IV

Locations

Country	Name	City	State
United States	Nutraceuticals Research Institute	Franklin	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Franklin Health Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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.
Primary	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.
Primary	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.
Primary	Glucose	Total glucose in blood via mg/dL	baseline, at 3 hours, and 24 hours post administration of intervention
Primary	Insulin Levels	Total insulin in blood via mcU/mL	baseline, at 3 hours, and 24 hours post administration of intervention
Primary	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
Primary	Tolerable Infusion Rate	The total amount of time it takes patients to comfortably receive the IV	through intervention completion, an average of 2 hours
Secondary	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
Secondary	Comprehensive Metabolic Panel	comprehensive metabolic panel will be evaluated through whole blood samples	baseline, at 3 hours, and 24 hours post administration of intervention
Secondary	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
Secondary	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