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

Not Applicable

Completed

• Conditions: Obese
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Nicotinamide riboside (NIAGEN TM, ChromaDex, CA, USA )

• Registration Number: NCT02303483
• Lead Sponsor: Aarhus University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-20
• Study First Submitted QC: 2014-11-28
• Study First Posted: 2014-12-01
• Study Start: 2016-01-04
• Primary Completion: 2017-04-04
• Study Completion: 2017-04-04
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-29
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	lime tablets
Nicotinamide riboside (NR, Vit B3)	Nicotinamide riboside (NIAGEN TM, ChromaDex, CA, USA )	NIAGEN (ChromaDex) 1 g x 2 orally per day

Primary Outcome Measures

Name	Time	Method
Insulin sensitivity	Change from baseline in insulin sensitivity at 3 months	determined by a hyperinsulineamic clamp

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medical Research Laboratories, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark