Nicotinamide Riboside and Metabolic Health

Not Applicable

Completed

• Conditions: Insulin Resistance; Obesity
• Interventions: Dietary Supplement: Nicotinamide Riboside (Niagen); Dietary Supplement: Placebo

• Registration Number: NCT02835664
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-08
• Study First Submitted QC: 2016-07-13
• Study First Posted: 2016-07-18
• Study Start: 2016-12
• Status Verified: 2018-04
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Last Update Submitted: 2019-03-20
• Last Update Posted: 2019-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nicotinamide Riboside	Nicotinamide Riboside (Niagen)	Supplementation of Nicotinamide Riboside (Niagen) of 1000 mg/day for 6 weeks. 2 capsules in the morning together with breakfast and 2 capsules around noon together with lunch. Each capsule contains 250 mg.
Nicotinamide Riboside	Placebo	Supplementation of Nicotinamide Riboside (Niagen) of 1000 mg/day for 6 weeks. 2 capsules in the morning together with breakfast and 2 capsules around noon together with lunch. Each capsule contains 250 mg.
Placebo	Nicotinamide Riboside (Niagen)	Supplementation of Placebo of 1000 mg/day for 6 weeks. 2 capsules in the morning together with breakfast and 2 capsules around noon together with lunch. Each capsule contains 250 mg.
Placebo	Placebo	Supplementation of Placebo of 1000 mg/day for 6 weeks. 2 capsules in the morning together with breakfast and 2 capsules around noon together with lunch. Each capsule contains 250 mg.

Primary Outcome Measures

Name	Time	Method
Insulin sensitivity: muscle- and liver specific	6 weeks after supplementation	Hyperinsulinemic euglycemic clamp: Rate of glucose disappearance (Rd) will be calculated by using tracer kinetics.

Secondary Outcome Measures

Name	Time	Method
Body composition	6 weeks after supplementation	Fat mass and fat free mass measured with a BodPod.
Muscle mitochondrial function (ex vivo)	6 weeks after supplementation	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.
Ectopic lipid accumulation	6 weeks after supplementation	Liver and skeletal muscle lipid accumulation measured with H-MRS in vivo.
Brown adipose tissue activity	6 weeks after supplementation	Subjects will be exposed to an individualized cooling protocol, after which an 18F-FDG PET/CT scan is made
Cardiovascular risk parameters	6 weeks after supplementation	Cardiac energy status measured with P-MRS and Ambulatory blood pressure.
Whole body energy expenditure	6 weeks after supplementation	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).
Acetylcarnitine levels	6 weeks after supplementation	Skeletal muscle acetylcarnitine levels measured with H-MRS in vivo, before and after exercise stimulation (cycling).

Trial Locations

Locations (1)

Maastricht University Medical Centre; 🇳🇱 Maastricht, Netherlands