Nicotinamide Riboside and Metabolic Health

Obesity Clinical Trial

Official title:

Effects of Nicotinamide Riboside on Metabolic Health in (Pre)Obese Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02835664
• Other study ID #: NL58119.068.16
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 2018

Study information

• Verified date: April 2018
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity

Intervention

Dietary Supplement:
• Nicotinamide Riboside (Niagen)

• Placebo

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Dutch Heart Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity: muscle- and liver specific	Hyperinsulinemic euglycemic clamp: Rate of glucose disappearance (Rd) will be calculated by using tracer kinetics.	6 weeks after supplementation
Secondary	Muscle mitochondrial function (ex vivo)	Ex vivo mitochondrial function in skeletal muscle measured by oxygen consumption in muscle fibres (muscle biopsy vastus lateralis) on lipid-derived and carbohydrate-derived substrates.	6 weeks after supplementation
Secondary	Ectopic lipid accumulation	Liver and skeletal muscle lipid accumulation measured with H-MRS in vivo.	6 weeks after supplementation
Secondary	Brown adipose tissue activity	Subjects will be exposed to an individualized cooling protocol, after which an 18F-FDG PET/CT scan is made	6 weeks after supplementation
Secondary	Cardiovascular risk parameters	Cardiac energy status measured with P-MRS and Ambulatory blood pressure.	6 weeks after supplementation
Secondary	Whole body energy expenditure	Sleeping metabolic rate measured during an overnight stay in a respiration chamber.; Resting metabolic rate measured with ventilated hood system, basal, during insulin stimulation (clamp) and during cold stimulation (cooling protocol BAT activity).	6 weeks after supplementation
Secondary	Body composition	Fat mass and fat free mass measured with a BodPod.	6 weeks after supplementation
Secondary	Acetylcarnitine levels	Skeletal muscle acetylcarnitine levels measured with H-MRS in vivo, before and after exercise stimulation (cycling).	6 weeks after supplementation