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

Not Applicable

Active, not recruiting

• Conditions: NAD
• Interventions: Dietary Supplement: Niagen; Other: Placebo

• Registration Number: NCT06005350
• Lead Sponsor: Charite University, Berlin, Germany

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.

Study Timeline

• Study First Submitted: 2023-08-09
• Study First Submitted QC: 2023-08-17
• Study First Posted: 2023-08-22
• Study Start: 2023-11-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-13
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NR-Treatment	Niagen	NR-Chloride Preparation 1000mg/day for 10 days (500mg - 0 - 500mg -0)
Placebo	Placebo	Placebo for 10 days (1 - 0 - 1 - 0)

Primary Outcome Measures

Name	Time	Method
NR increases plasma concentrations of eNAD+	10 days	The daily intake of 1,000 mg of NR changes the concentration of eNAD+ over the course of 10 days. The NAD+ assay measures the changes in concentrations of eNAD+ in plasma.

Trial Locations

Locations (1)

Surgical Clinic, Campus Virchow-Klinikum / Campus Charité Mitte, Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany