Clinical trial NCT02303483: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obese
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2014-12-01
Enrollment: 40
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Insulin sensitivity
timeFrame: Change from baseline in insulin sensitivity at 3 months
Secondary outcomes:
measure: Substrate metabolism
timeFrame: Change from baseline in substrate metabolism at 3 months
measure: body composition
timeFrame: Change from baseline in body composition at 3 months
measure: Activation of satellite cells
timeFrame: Change from baseline in activation of satellite cells at 3 months
measure: lipid accumulation in liver and skeletal muscle tissue
timeFrame: Change from baseline in liver and muscle lipid content at 3 months
measure: glucose turnover
timeFrame: Change from baseline in glucose turnover at 3 months
measure: insulin signalling in skeletal muscle and adipose tissue biopsies
timeFrame: Change from baseline in insulin signaling at 3 months
measure: Palmitate turnover
timeFrame: Change from baseline in palmitate turnover at 3 months
measure: Gut microbiota
timeFrame: Change from baseline in composition of gut microbiota at 3 months
measure: Incretin hormone secretion
timeFrame: Change from baseline in incretion hormone secretion at 3 months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Medical Research Laboratories, Aarhus University Hospital
Study officials:
affiliation: The Novo Nordisk Foundation Center for Basic Metabolic Research, Integrative Physiology, University of Copenhagen
name: Ole Dollerup, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.