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

Franklin Health Research

Status: Active, not recruiting

Conditions: Healthy Aging

Treatments: Dietary Supplement: Niagen® (nicotinamide riboside) oral; Dietary Supplement: NAD+ (nicotinamide adenine dinucleotide) IV; Other: Placebo; Dietary Supplement: Niagen® (nicotinamide riboside) IV

Study type: Interventional

Funder types: Other

Identifiers

NCT06382688

23-08-0010

Details and patient eligibility

About

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.

Full 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®

Enrollment: 53 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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53 participants in 4 patient groups, including a placebo group

NR (Cohorts 1&2)

Experimental group

Description:

IV administered 500 mg of sterile Niagen® (nicotinamide riboside chloride) diluted, in 500 ml of saline

Treatment:

Dietary Supplement: Niagen® (nicotinamide riboside) IV

Active Comparator (Cohorts 1&2)

Active Comparator group

Description:

IV administered 500 mg of sterile nicotinamide adenine dinucleotide in 500 ml of saline

Treatment:

Dietary Supplement: NAD+ (nicotinamide adenine dinucleotide) IV

Oral Comparator (Cohort 1 only)

Other group

Description:

orally administered 500 mg of sterile Niagen® (nicotinamide riboside chloride) in capsules

Treatment:

Dietary Supplement: Niagen® (nicotinamide riboside) oral

Placebo (Cohort 1 only)

Placebo Comparator group

Description:

IV administered 500 ml of saline

Treatment:

Other: Placebo