NCT02300740

Brief Summary

Nicotinamide riboside is a newly discovered vitamin B3. The pharmacokinetics in humans is so far not analyzed.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at P25-P50 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

November 20, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 25, 2014

Completed
6 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Last Updated

February 27, 2015

Status Verified

November 1, 2014

Enrollment Period

2 months

First QC Date

November 20, 2014

Last Update Submit

February 26, 2015

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

  • Serum nicotinamide riboside

    8 hours, blood samples every 15 min

Secondary Outcomes (5)

  • serum concentrations of metabolites of nicotinamide riboside

    8 hour, blood samples every 15 min

  • area under the curve for serum nicotinamide riboside

    8 hours, blood samples every 15 min

  • calculation of halftime of serum nicotinamide riboside

    8 hours, blood samples every 15 min

  • calculation of C-max of serum nicotinamide riboside

    8 hours, blood samples every 15 min

  • calculation of t-max of serum nicotinamide riboside

    8 hours, blood samples every 15 min

Study Arms (2)

low dose

EXPERIMENTAL

500 mg nicotinamide riboside oral

Dietary Supplement: Nicotinamide riboside

high dose

EXPERIMENTAL

1000 mg nicotinamide riboside oral

Dietary Supplement: Nicotinamide riboside

Interventions

Nicotinamide ribosideDIETARY_SUPPLEMENT

NIAGEN, ChromaDex

high doselow dose

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 18-25, healthy, male,

You may not qualify if:

  • liver or kidney diseases, other diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Research Laboratories, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Interventions

nicotinamide-beta-riboside

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cand.Scient, PhD, Post doc

Study Record Dates

First Submitted

November 20, 2014

First Posted

November 25, 2014

Study Start

December 1, 2014

Primary Completion

February 1, 2015

Last Updated

February 27, 2015

Record last verified: 2014-11

Locations

DK(1)