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Nicotinamide Riboside Impact on Extracellular Nicotinamide Adenine Dinucleotide (NAD+) (NICE)

Charité University Medicine Berlin logo

Charité University Medicine Berlin

Status

Active, not recruiting

Conditions

NAD

Treatments

Dietary Supplement: Niagen
Other: Placebo

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT06005350
EA4/210/19

Details and patient eligibility

About

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.

Full 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.

Enrollment

54 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

54 participants in 2 patient groups, including a placebo group

NR-Treatment
Experimental group
Description:
NR-Chloride Preparation 1000mg/day for 10 days (500mg - 0 - 500mg -0)
Treatment:
Dietary Supplement: Niagen
Placebo
Placebo Comparator group
Description:
Placebo for 10 days (1 - 0 - 1 - 0)
Treatment:
Other: Placebo

Trial contacts and locations

1

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Central trial contact

Can Kamali, MD

Data sourced from clinicaltrials.gov

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