Clinical trial NCT02835664: Nicotinamide Riboside and Metabolic Health
Official title: Effects of Nicotinamide Riboside on Metabolic Health in (Pre)Obese Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Insulin Resistance
Keywords: Nicotinamide Riboside
Obesity
Metabolic health
Insulin resistance
Mitochondrial function
Brown adipose tissue
Energy expenditure
Ectopic lipid accumulation
Cardiovascular risk
Acetylcarnitine
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Dutch Heart Foundation
First posted: 2016-07-18
Enrollment: 15
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will investigate the effects of 6 week Nicotinamide Riboside supplementation (1000 mg/day) on metabolic health in healthy (pre)obese humans. The primary objective will be hepatic and whole body insulin sensitivity. Secondary objectives, to provide information about the underlying mechanism, will be muscle mitochondrial function, brown fat activity, ectopic lipid accumulation, energy metabolism, cardiovascular risk parameters, body composition and acetylcarnitine levels.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Caucasian
* Males and postmenopausal females
* Aged 45-65 years at start of the study
* Body mass index (BMI) 27 - 35 kg/m2
* Stable dietary habits (no weight loss or gain \>5kg in the past 3 months)
* Sedentary lifestyle (not more than 2 hours of sports per week)

Exclusion Criteria:

* Type 2 diabetes
* Active diseases (cardiovascular, diabetes, liver, kidney, cancer or other)
* Contra-indication for MRI
* Participation in earlier research or medical examination that included PET/CT scanning
* Alcohol consumption of \>2 servings per day
* Smoking in the past 6 months

Primary outcomes:
measure: Insulin sensitivity: muscle- and liver specific
timeFrame: 6 weeks after supplementation
Secondary outcomes:
measure: Muscle mitochondrial function (ex vivo)
timeFrame: 6 weeks after supplementation
measure: Ectopic lipid accumulation
timeFrame: 6 weeks after supplementation
measure: Brown adipose tissue activity
timeFrame: 6 weeks after supplementation
measure: Cardiovascular risk parameters
timeFrame: 6 weeks after supplementation
measure: Whole body energy expenditure
timeFrame: 6 weeks after supplementation
measure: Body composition
timeFrame: 6 weeks after supplementation
measure: Acetylcarnitine levels
timeFrame: 6 weeks after supplementation
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
Study officials:
affiliation: Maastricht University Medical Center
name: Patrick Schrauwen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nascimento EBM, Moonen MPB, Remie CME, Gariani K, Jorgensen JA, Schaart G, Hoeks J, Auwerx J, van Marken Lichtenbelt WD, Schrauwen P. Nicotinamide Riboside Enhances In Vitro Beta-adrenergic Brown Adipose Tissue Activity in Humans. J Clin Endocrinol Metab. 2021 Apr 23;106(5):1437-1447. doi: 10.1210/clinem/dgaa960.
citation: Remie CME, Roumans KHM, Moonen MPB, Connell NJ, Havekes B, Mevenkamp J, Lindeboom L, de Wit VHW, van de Weijer T, Aarts SABM, Lutgens E, Schomakers BV, Elfrink HL, Zapata-Perez R, Houtkooper RH, Auwerx J, Hoeks J, Schrauwen-Hinderling VB, Phielix E, Schrauwen P. Nicotinamide riboside supplementation alters body composition and skeletal muscle acetylcarnitine concentrations in healthy obese humans. Am J Clin Nutr. 2020 Aug 1;112(2):413-426. doi: 10.1093/ajcn/nqaa072.