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

Primary Purpose

Obese

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Nicotinamide riboside (NIAGEN TM, ChromaDex, CA, USA )
Placebo
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obese

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Medical Research Laboratories, Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Nicotinamide riboside (NR, Vit B3)

Arm Description

lime tablets

NIAGEN (ChromaDex) 1 g x 2 orally per day

Outcomes

Primary Outcome Measures

Insulin sensitivity
determined by a hyperinsulineamic clamp

Secondary Outcome Measures

Substrate metabolism
measured by indirect calorimetry
body composition
measured by DEXA scan
Activation of satellite cells
measured by immunohistochemestry
lipid accumulation in liver and skeletal muscle tissue
determined by MR-spectroscopy
glucose turnover
determined by glucose tracer techniques
insulin signalling in skeletal muscle and adipose tissue biopsies
western blotting
Palmitate turnover
determined by palmitate tracer techniques
Gut microbiota
Intestinal bacteria composition by whole genome sequencing
Incretin hormone secretion
Determined by measurement of incretin homones during an oral glucose tolerance test (OGTT)

Full Information

First Posted
November 20, 2014
Last Updated
June 29, 2017
Sponsor
Aarhus University Hospital
Collaborators
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT02303483
Brief Title
The Effect of Vitamin B3 on Substrate Metabolism, Insulin Sensitivity, and Body Composition in Obese Men
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
January 4, 2016 (Actual)
Primary Completion Date
April 4, 2017 (Actual)
Study Completion Date
April 4, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital
Collaborators
University of Copenhagen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obese

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
lime tablets
Arm Title
Nicotinamide riboside (NR, Vit B3)
Arm Type
Experimental
Arm Description
NIAGEN (ChromaDex) 1 g x 2 orally per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Nicotinamide riboside (NIAGEN TM, ChromaDex, CA, USA )
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Insulin sensitivity
Description
determined by a hyperinsulineamic clamp
Time Frame
Change from baseline in insulin sensitivity at 3 months
Secondary Outcome Measure Information:
Title
Substrate metabolism
Description
measured by indirect calorimetry
Time Frame
Change from baseline in substrate metabolism at 3 months
Title
body composition
Description
measured by DEXA scan
Time Frame
Change from baseline in body composition at 3 months
Title
Activation of satellite cells
Description
measured by immunohistochemestry
Time Frame
Change from baseline in activation of satellite cells at 3 months
Title
lipid accumulation in liver and skeletal muscle tissue
Description
determined by MR-spectroscopy
Time Frame
Change from baseline in liver and muscle lipid content at 3 months
Title
glucose turnover
Description
determined by glucose tracer techniques
Time Frame
Change from baseline in glucose turnover at 3 months
Title
insulin signalling in skeletal muscle and adipose tissue biopsies
Description
western blotting
Time Frame
Change from baseline in insulin signaling at 3 months
Title
Palmitate turnover
Description
determined by palmitate tracer techniques
Time Frame
Change from baseline in palmitate turnover at 3 months
Title
Gut microbiota
Description
Intestinal bacteria composition by whole genome sequencing
Time Frame
Change from baseline in composition of gut microbiota at 3 months
Title
Incretin hormone secretion
Description
Determined by measurement of incretin homones during an oral glucose tolerance test (OGTT)
Time Frame
Change from baseline in incretion hormone secretion at 3 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ole Dollerup, MD
Organizational Affiliation
The Novo Nordisk Foundation Center for Basic Metabolic Research, Integrative Physiology, University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Research Laboratories, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
31710095
Citation
Dollerup OL, Chubanava S, Agerholm M, Sondergard SD, Altintas A, Moller AB, Hoyer KF, Ringgaard S, Stodkilde-Jorgensen H, Lavery GG, Barres R, Larsen S, Prats C, Jessen N, Treebak JT. Nicotinamide riboside does not alter mitochondrial respiration, content or morphology in skeletal muscle from obese and insulin-resistant men. J Physiol. 2020 Feb;598(4):731-754. doi: 10.1113/JP278752. Epub 2019 Dec 26.
Results Reference
derived
PubMed Identifier
31390002
Citation
Dollerup OL, Trammell SAJ, Hartmann B, Holst JJ, Christensen B, Moller N, Gillum MP, Treebak JT, Jessen N. Effects of Nicotinamide Riboside on Endocrine Pancreatic Function and Incretin Hormones in Nondiabetic Men With Obesity. J Clin Endocrinol Metab. 2019 Nov 1;104(11):5703-5714. doi: 10.1210/jc.2019-01081.
Results Reference
derived
PubMed Identifier
29992272
Citation
Dollerup OL, Christensen B, Svart M, Schmidt MS, Sulek K, Ringgaard S, Stodkilde-Jorgensen H, Moller N, Brenner C, Treebak JT, Jessen N. A randomized placebo-controlled clinical trial of nicotinamide riboside in obese men: safety, insulin-sensitivity, and lipid-mobilizing effects. Am J Clin Nutr. 2018 Aug 1;108(2):343-353. doi: 10.1093/ajcn/nqy132.
Results Reference
derived

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

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