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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy Aging
• Intervention / Treatment: Dietary supplement: Niagen® (nicotinamide riboside) IV; Dietary supplement: NAD+ (nicotinamide adenine dinucleotide) IV; Dietary supplement: Niagen® (nicotinamide riboside) oral; Other: Placebo

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®

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Franklin, Tennessee, United States, 37067
      • Nutraceuticals Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NR (Cohorts 1&2); IV administered 500 mg of sterile Niagen® (nicotinamide riboside chloride) diluted, in 500 ml of saline	Dietary supplement: 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.
Active Comparator: Active Comparator (Cohorts 1&2); IV administered 500 mg of sterile nicotinamide adenine dinucleotide in 500 ml of saline	Dietary supplement: NAD+ (nicotinamide adenine dinucleotide) IV; NAD+ enables cells to generate cellular energy from the food that one eats; Other Names: NAD+
Other: Oral Comparator (Cohort 1 only); orally administered 500 mg of sterile Niagen® (nicotinamide riboside chloride) in capsules	Dietary supplement: 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 Names: Niagen® (oral)
Placebo Comparator: Placebo (Cohort 1 only); IV administered 500 ml of saline	Other: Placebo; These individuals received a saline IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	through intervention completion, an average of 2 hours

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Franklin Health Research

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2023
• Primary Completion (Actual): March 8, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: April 4, 2024
• First Submitted That Met QC Criteria: April 23, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Niagen; nicotinamide adenine dinucleotide; nicotinamide riboside chloride
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Antimetabolites; Micronutrients; Hypolipidemic Agents; Lipid Regulating Agents; Vitamins; Vitamin B Complex; Nicotinic Acids; Niacinamide; Niacin
• Other Study ID Numbers: 23-08-0010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Patient consent does not include data sharing outside of pre-specified organizations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No