Clinical trial NCT06005350: Nicotinamide Riboside Impact on Extracellular Nicotinamide Adenine Dinucleotide (NAD+)
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: NAD
Keywords: Nicotinamide riboside
extracellular NAD+
enzymatic assay
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: ChromaDex, Inc.
First posted: 2023-08-22
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

* Good general health
* Normal nutritional status and
* Age \>18 years.

Exclusion Criteria:

* Pregnancy and/or lactation, or
* Severe psychiatric disorders, or
* Conditions that involve attention deficits, or
* Severe medical conditions, or
* Withdrawal of consent by the participant.

Primary outcomes:
measure: NR increases plasma concentrations of eNAD+
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Surgical Clinic, Campus Virchow-Klinikum / Campus Charité Mitte, Charité - Universitätsmedizin Berlin
Study officials:
References:
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