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The Effect of Vitamin B3 on Substrate Metabolism, Insulin Sensitivity, and Body Composition in Obese Men

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02303483
First Posted: December 1, 2014
Last Update Posted: July 2, 2017
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):
Ole Dollerup, Aarhus University Hospital
  Purpose
In animals, treatment with vitamin B3 improved insulin sensitivity and substrate metabolism. It is currently not know if vitamin B3 has the same positive effects in humans. In the current study the effect of a 3 month treatment with vitamin B3 on insulin sensitivity and substrate metabolism in obese men will be investigated.

Condition Intervention
Obese Dietary Supplement: Nicotinamide riboside (NIAGEN TM, ChromaDex, CA, USA ) Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Nicotinamide Ribose (NR) on Substrate Metabolism, Insulin Sensitivity, and Body Composition in Obese Men - a Randomized, Placebo Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Ole Dollerup, Aarhus University Hospital:

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: Change from baseline in insulin sensitivity at 3 months ]
    determined by a hyperinsulineamic clamp


Secondary Outcome Measures:
  • Substrate metabolism [ Time Frame: Change from baseline in substrate metabolism at 3 months ]
    measured by indirect calorimetry

  • body composition [ Time Frame: Change from baseline in body composition at 3 months ]
    measured by DEXA scan

  • Activation of satellite cells [ Time Frame: Change from baseline in activation of satellite cells at 3 months ]
    measured by immunohistochemestry

  • lipid accumulation in liver and skeletal muscle tissue [ Time Frame: Change from baseline in liver and muscle lipid content at 3 months ]
    determined by MR-spectroscopy

  • glucose turnover [ Time Frame: Change from baseline in glucose turnover at 3 months ]
    determined by glucose tracer techniques

  • insulin signalling in skeletal muscle and adipose tissue biopsies [ Time Frame: Change from baseline in insulin signaling at 3 months ]
    western blotting

  • Palmitate turnover [ Time Frame: Change from baseline in palmitate turnover at 3 months ]
    determined by palmitate tracer techniques

  • Gut microbiota [ Time Frame: Change from baseline in composition of gut microbiota at 3 months ]
    Intestinal bacteria composition by whole genome sequencing

  • Incretin hormone secretion [ Time Frame: Change from baseline in incretion hormone secretion at 3 months ]
    Determined by measurement of incretin homones during an oral glucose tolerance test (OGTT)


Enrollment: 40
Actual Study Start Date: January 4, 2016
Study Completion Date: April 4, 2017
Primary Completion Date: April 4, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
lime tablets
Dietary Supplement: Placebo
Experimental: Nicotinamide riboside (NR, Vit B3)
NIAGEN (ChromaDex) 1 g x 2 orally per day
Dietary Supplement: Nicotinamide riboside (NIAGEN TM, ChromaDex, CA, USA )

  Eligibility

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • written signed consent
  • male
  • BMI>30 kg/(m2)
  • age: 40-70
  • no medication
  • non-smoker

Exclusion Criteria:

  • endocrine disease
  • other severe disease
  • high daily activity level (>30 min / day)
  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): NCT02303483


Locations
Denmark
Medical Research Laboratories, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
Aarhus University Hospital
University of Copenhagen
Investigators
Principal Investigator: Ole Dollerup, MD The Novo Nordisk Foundation Center for Basic Metabolic Research, Integrative Physiology, University of Copenhagen
  More Information

Responsible Party: Ole Dollerup, MD, PhD-student, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT02303483     History of Changes
Other Study ID Numbers: 44081
First Submitted: November 20, 2014
First Posted: December 1, 2014
Last Update Posted: July 2, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Niacinamide
Niacin
Nicotinic Acids
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents