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

The Effect of Nicotinamide Ribose (NR) on Substrate Metabolism, Insulin Sensitivity, and Body Composition in Obese Men - a Randomized, Placebo Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Obese
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Nicotinamide riboside (NIAGEN TM, ChromaDex, CA, USA )

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 )

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin sensitivity	determined by a hyperinsulineamic clamp	Change from baseline in insulin sensitivity at 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Substrate metabolism	measured by indirect calorimetry	Change from baseline in substrate metabolism at 3 months
body composition	measured by DEXA scan	Change from baseline in body composition at 3 months
Activation of satellite cells	measured by immunohistochemestry	Change from baseline in activation of satellite cells at 3 months
lipid accumulation in liver and skeletal muscle tissue	determined by MR-spectroscopy	Change from baseline in liver and muscle lipid content at 3 months
glucose turnover	determined by glucose tracer techniques	Change from baseline in glucose turnover at 3 months
insulin signalling in skeletal muscle and adipose tissue biopsies	western blotting	Change from baseline in insulin signaling at 3 months
Palmitate turnover	determined by palmitate tracer techniques	Change from baseline in palmitate turnover at 3 months
Gut microbiota	Intestinal bacteria composition by whole genome sequencing	Change from baseline in composition of gut microbiota at 3 months
Incretin hormone secretion	Determined by measurement of incretin homones during an oral glucose tolerance test (OGTT)	Change from baseline in incretion hormone secretion at 3 months

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Collaborators: University of Copenhagen
• Investigators: Principal Investigator: Ole Dollerup, MD, The Novo Nordisk Foundation Center for Basic Metabolic Research, Integrative Physiology, University of Copenhagen

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2016
• Primary Completion (Actual): April 4, 2017
• Study Completion (Actual): April 4, 2017

Study Registration Dates

• First Submitted: November 20, 2014
• First Submitted That Met QC Criteria: November 28, 2014
• First Posted (Estimate): December 1, 2014

Study Record Updates

• Last Update Posted (Actual): July 2, 2017
• Last Update Submitted That Met QC Criteria: June 29, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Antimetabolites; Micronutrients; Hypolipidemic Agents; Lipid Regulating Agents; Vitamins; Vitamin B Complex; Nicotinic Acids; Niacinamide; Niacin
• Other Study ID Numbers: 44081