Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2026-01-01 @ 11:30 AM
Study NCT ID:
NCT06005350
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2023-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nicotinamide Riboside Impact on Extracellular Nicotinamide Adenine Dinucleotide (NAD+)
Sponsor:
Charite University, Berlin, Germany
Organization:
Study Overview
Official Title:
Validation of an Enzymatic Assay for Quantification of Nicotinamide Adenine Dinucleotide in Blood Plasma After Ingestion of the Vitamin B3 Variant Nicotinamide Riboside: a Randomized Controlled Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NICE
Brief Summary:
The investigation is a clinical study in which the impact of taking the dietary supplement nicotinamide riboside (NR) on the concentration of extracellular nicotinamide adenine dinucleotide (eNAD+) in human plasma over time will be determined. The study will be conducted in a randomized, double-blinded, and placebo-controlled manner.
Detailed Description:
The significance of nicotinamide adenine dinucleotide (NAD+) in promoting a healthy life is currently under intense research. Despite an increasing number of research groups focusing on NAD+, there is no validated measurement method for extracellular NAD+. With this research project, the investigators aim to address this research gap.
The coenzyme NAD+ is one of the central regulators of metabolism, existing mostly in its oxidized form, NAD+, and its reduced form, NADH, in a dynamic equilibrium. NAD+ is indispensable for various metabolic processes, and is especially key in ATP generation. It also enables gluconeogenesis, ketogenesis, pentose phosphate production, heme and lipid synthesis, and the elimination of oxygen radicals.
To validate the NAD+ assay as a robust and reliable quantification method of extracellular NAD+, a controlled increase of the measured metabolite in blood plasma is required through NAD+ precursor administration.
Multiple studies have already demonstrated that oral NR intake can increase NAD+ levels in mammalian cells, rodent tissues, and peripheral blood mononuclear cells (PBMCs) in humans. However, this relationship has not been explored in the extracellular space due to the lack of reliable quantification of eNAD+ levels. Now, using the NAD+ assay, the investigators aim to examine the increase of eNAD+ after oral NR intake and provide initial data on the effects of a 1000 mg/day dosage.
The coenzyme NAD+ is one of the central regulators of metabolism, existing mostly in its oxidized form, NAD+, and its reduced form, NADH, in a dynamic equilibrium. NAD+ is indispensable for various metabolic processes, and is especially key in ATP generation. It also enables gluconeogenesis, ketogenesis, pentose phosphate production, heme and lipid synthesis, and the elimination of oxygen radicals.
To validate the NAD+ assay as a robust and reliable quantification method of extracellular NAD+, a controlled increase of the measured metabolite in blood plasma is required through NAD+ precursor administration.
Multiple studies have already demonstrated that oral NR intake can increase NAD+ levels in mammalian cells, rodent tissues, and peripheral blood mononuclear cells (PBMCs) in humans. However, this relationship has not been explored in the extracellular space due to the lack of reliable quantification of eNAD+ levels. Now, using the NAD+ assay, the investigators aim to examine the increase of eNAD+ after oral NR intake and provide initial data on the effects of a 1000 mg/day dosage.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: