NCT06005350

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

1.2 years

First QC Date

August 9, 2023

Last Update Submit

June 12, 2024

Conditions

NAD

Keywords

Nicotinamide ribosideextracellular NAD+enzymatic assay

Outcome Measures

Primary Outcomes (1)

  • NR increases plasma concentrations of eNAD+

    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.

    10 days

Study Arms (2)

NR-Treatment

EXPERIMENTAL

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

Dietary Supplement: Niagen

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

NiagenDIETARY_SUPPLEMENT

Nicotinamide-Riboside-Chloride Preparation 1000mg/day

NR-Treatment
PlaceboOTHER

Placebo Preperation

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Surgical Clinic, Campus Virchow-Klinikum / Campus Charité Mitte, Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

Related Publications (8)

  • Bogan KL, Brenner C. Nicotinic acid, nicotinamide, and nicotinamide riboside: a molecular evaluation of NAD+ precursor vitamins in human nutrition. Annu Rev Nutr. 2008;28:115-30. doi: 10.1146/annurev.nutr.28.061807.155443.

    PMID: 18429699BACKGROUND

  • Brunnbauer P, Leder A, Kamali C, Kamali K, Keshi E, Splith K, Wabitsch S, Haber P, Atanasov G, Feldbrugge L, Sauer IM, Pratschke J, Schmelzle M, Krenzien F. The nanomolar sensing of nicotinamide adenine dinucleotide in human plasma using a cycling assay in albumin modified simulated body fluids. Sci Rep. 2018 Oct 31;8(1):16110. doi: 10.1038/s41598-018-34350-6.

    PMID: 30382125BACKGROUND

  • Canto C, Houtkooper RH, Pirinen E, Youn DY, Oosterveer MH, Cen Y, Fernandez-Marcos PJ, Yamamoto H, Andreux PA, Cettour-Rose P, Gademann K, Rinsch C, Schoonjans K, Sauve AA, Auwerx J. The NAD(+) precursor nicotinamide riboside enhances oxidative metabolism and protects against high-fat diet-induced obesity. Cell Metab. 2012 Jun 6;15(6):838-47. doi: 10.1016/j.cmet.2012.04.022.

    PMID: 22682224BACKGROUND

  • Chi Y, Sauve AA. Nicotinamide riboside, a trace nutrient in foods, is a vitamin B3 with effects on energy metabolism and neuroprotection. Curr Opin Clin Nutr Metab Care. 2013 Nov;16(6):657-61. doi: 10.1097/MCO.0b013e32836510c0.

    PMID: 24071780BACKGROUND

  • Dolopikou CF, Kourtzidis IA, Margaritelis NV, Vrabas IS, Koidou I, Kyparos A, Theodorou AA, Paschalis V, Nikolaidis MG. Acute nicotinamide riboside supplementation improves redox homeostasis and exercise performance in old individuals: a double-blind cross-over study. Eur J Nutr. 2020 Mar;59(2):505-515. doi: 10.1007/s00394-019-01919-4. Epub 2019 Feb 6.

    PMID: 30725213BACKGROUND

  • Imai SI, Guarente L. It takes two to tango: NAD+ and sirtuins in aging/longevity control. NPJ Aging Mech Dis. 2016 Aug 18;2:16017. doi: 10.1038/npjamd.2016.17. eCollection 2016.

    PMID: 28721271BACKGROUND

  • Trammell SA, Schmidt MS, Weidemann BJ, Redpath P, Jaksch F, Dellinger RW, Li Z, Abel ED, Migaud ME, Brenner C. Nicotinamide riboside is uniquely and orally bioavailable in mice and humans. Nat Commun. 2016 Oct 10;7:12948. doi: 10.1038/ncomms12948.

    PMID: 27721479BACKGROUND

  • Yoshino J, Baur JA, Imai SI. NAD+ Intermediates: The Biology and Therapeutic Potential of NMN and NR. Cell Metab. 2018 Mar 6;27(3):513-528. doi: 10.1016/j.cmet.2017.11.002. Epub 2017 Dec 14.

    PMID: 29249689BACKGROUND

MeSH Terms

Interventions

nicotinamide-beta-riboside

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 9, 2023

First Posted

August 22, 2023

Study Start

November 1, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

June 13, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)