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

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06005350
Collaborator
ChromaDex, Inc. (Industry)
54
1
2
7.9
6.8

Study Details

Study Description

Brief Summary

The investigation is a clinical study in which the impact of taking the dietary supplement NR on the concentration of eNAD+ in human plasma over time will be determined. The study will be conducted in a randomized, double-blinded, and placebo-controlled manner.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Niagen
  • Other: Placebo
N/A

Detailed Description

The significance of 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 plays a central role, especially 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 Design

Study Type:
Interventional
Anticipated Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Clinical Study to Validate an Enzymatic Assay for Quantification of Nicotinamide Adenine Dinucleotide in Blood Plasma After Ingestion of the Vitamin B3 Variant Nicotinamide Riboside.
Anticipated Study Start Date :
Sep 4, 2023
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: NR-Treatment

NR-Chlorid Preparation 1000mg/day for 10 days (500mg - 0 - 500mg -0)

Dietary Supplement: Niagen
Nicotinamide-Riboside-Chloride Preparation 1000mg/day

Placebo Comparator: Placebo

Placebo for 10 days (1 - 0 - 1 - 0)

Other: Placebo
Placebo Preperation

Outcome Measures

Primary Outcome Measures

  1. NR increases 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 of eNAD+ in plasma.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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 a general impairment of attentional performance, or

  • Severe internal medical conditions, or

  • Withdrawal of consent by the participant.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Surgical Clinic, Campus Virchow-Klinikum / Campus Charité Mitte, Charité - Universitätsmedizin Berlin Berlin Germany 13353

Sponsors and Collaborators

  • Charite University, Berlin, Germany
  • ChromaDex, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Felix Krenzien, Principle Investigator, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT06005350
Other Study ID Numbers:
  • NR-Charite
First Posted:
Aug 22, 2023
Last Update Posted:
Aug 24, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Felix Krenzien, Principle Investigator, Charite University, Berlin, Germany

Study Results

No Results Posted as of Aug 24, 2023