Nicotinamide Riboside and Metabolic Health

Overview

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.

Full Title of Study: “Effects of Nicotinamide Riboside on Metabolic Health in (Pre)Obese Humans”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2018

Interventions

  • Dietary Supplement: Nicotinamide Riboside (Niagen)
  • Dietary Supplement: Placebo

Arms, Groups and Cohorts

  • Experimental: Nicotinamide Riboside
    • 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 Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Muscle mitochondrial function (ex vivo)
    • Time Frame: 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
    • Time Frame: 6 weeks after supplementation
    • Liver and skeletal muscle lipid accumulation measured with H-MRS in vivo.
  • Brown adipose tissue activity
    • Time Frame: 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
    • Time Frame: 6 weeks after supplementation
    • Cardiac energy status measured with P-MRS and Ambulatory blood pressure.
  • Whole body energy expenditure
    • Time Frame: 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).
  • Body composition
    • Time Frame: 6 weeks after supplementation
    • Fat mass and fat free mass measured with a BodPod.
  • Acetylcarnitine levels
    • Time Frame: 6 weeks after supplementation
    • Skeletal muscle acetylcarnitine levels measured with H-MRS in vivo, before and after exercise stimulation (cycling).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 45 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Maastricht University Medical Center
  • Collaborator
    • Dutch Heart Foundation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Patrick Schrauwen, PhD, Principal Investigator, Maastricht University Medical Center

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