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Pharmacokinetic Analysis of Nicotinamide Riboside

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02300740
First Posted: November 25, 2014
Last Update Posted: February 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Britt Christensen, Aarhus University Hospital
  Purpose
Nicotinamide riboside is a newly discovered vitamin B3. The pharmacokinetics in humans is so far not analyzed.

Condition Intervention Phase
Healthy Participants Dietary Supplement: Nicotinamide riboside Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Britt Christensen, Aarhus University Hospital:

Primary Outcome Measures:
  • Serum nicotinamide riboside [ Time Frame: 8 hours, blood samples every 15 min ]

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

Enrollment: 12
Study Start Date: December 2014
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI 18-25, healthy, male,

Exclusion Criteria:

  • liver or kidney diseases, other diseases
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300740


Locations
Denmark
Medical Research Laboratories, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
Aarhus University Hospital
University of Copenhagen
  More Information

Responsible Party: Britt Christensen, Cand.Scient, PhD, Post doc, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT02300740     History of Changes
Other Study ID Numbers: 45141
First Submitted: November 20, 2014
First Posted: November 25, 2014
Last Update Posted: February 27, 2015
Last Verified: November 2014

Additional relevant MeSH terms:
Niacinamide
Niacin
Nicotinic Acids
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents