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

Obese Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02303483
• Other study ID #: 44081
• Status: Completed
• Phase: N/A
• First received: November 20, 2014
• Last updated: June 29, 2017
• Start date: January 4, 2016
• Est. completion date: April 4, 2017

Study information

• Verified date: June 2017
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 4, 2017
• Est. primary completion date: April 4, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Insulin Resistance
• Obese

Intervention

Dietary Supplement:
• Nicotinamide riboside (NIAGEN TM, ChromaDex, CA, USA )

• Placebo

Locations

Country	Name	City	State
Denmark	Medical Research Laboratories, Aarhus University Hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
Aarhus University Hospital	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity	determined by a hyperinsulineamic clamp	Change from baseline in insulin sensitivity at 3 months
Secondary	Substrate metabolism	measured by indirect calorimetry	Change from baseline in substrate metabolism at 3 months
Secondary	body composition	measured by DEXA scan	Change from baseline in body composition at 3 months
Secondary	Activation of satellite cells	measured by immunohistochemestry	Change from baseline in activation of satellite cells at 3 months
Secondary	lipid accumulation in liver and skeletal muscle tissue	determined by MR-spectroscopy	Change from baseline in liver and muscle lipid content at 3 months
Secondary	glucose turnover	determined by glucose tracer techniques	Change from baseline in glucose turnover at 3 months
Secondary	insulin signalling in skeletal muscle and adipose tissue biopsies	western blotting	Change from baseline in insulin signaling at 3 months
Secondary	Palmitate turnover	determined by palmitate tracer techniques	Change from baseline in palmitate turnover at 3 months
Secondary	Gut microbiota	Intestinal bacteria composition by whole genome sequencing	Change from baseline in composition of gut microbiota at 3 months
Secondary	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