Pharmacokinetic Analysis of Nicotinamide Riboside

February 26, 2015 updated by: Britt Christensen, Aarhus University Hospital
Nicotinamide riboside is a newly discovered vitamin B3. The pharmacokinetics in humans is so far not analyzed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Medical Research Laboratories, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • BMI 18-25, healthy, male,

Exclusion Criteria:

  • liver or kidney diseases, other diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: low dose
500 mg nicotinamide riboside oral
Dietary supplement: Nicotinamide riboside
NIAGEN, ChromaDex
Experimental: high dose
1000 mg nicotinamide riboside oral
Dietary supplement: Nicotinamide riboside
NIAGEN, ChromaDex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum nicotinamide riboside
Time Frame: 8 hours, blood samples every 15 min
8 hours, blood samples every 15 min

Secondary Outcome Measures

Outcome Measure
Time Frame
serum concentrations of metabolites of nicotinamide riboside
Time Frame: 8 hour, blood samples every 15 min
8 hour, blood samples every 15 min
area under the curve for serum nicotinamide riboside
Time Frame: 8 hours, blood samples every 15 min
8 hours, blood samples every 15 min
calculation of halftime of serum nicotinamide riboside
Time Frame: 8 hours, blood samples every 15 min
8 hours, blood samples every 15 min
calculation of C-max of serum nicotinamide riboside
Time Frame: 8 hours, blood samples every 15 min
8 hours, blood samples every 15 min
calculation of t-max of serum nicotinamide riboside
Time Frame: 8 hours, blood samples every 15 min
8 hours, blood samples every 15 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital

Collaborators

University of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

November 20, 2014

First Submitted That Met QC Criteria

November 21, 2014

First Posted (Estimate)

November 25, 2014

Study Record Updates

Last Update Posted (Estimate)

February 27, 2015

Last Update Submitted That Met QC Criteria

February 26, 2015

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 45141

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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