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Nicotinamide Riboside and Metabolic Health

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ClinicalTrials.gov Identifier: NCT02835664
Recruitment Status : Recruiting
First Posted : July 18, 2016
Last Update Posted : December 22, 2016
Dutch Heart Foundation
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Obesity Insulin Resistance Dietary Supplement: Nicotinamide Riboside (Niagen) Dietary Supplement: Placebo

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Nicotinamide Riboside on Metabolic Health in (Pre)Obese Humans
Study Start Date : December 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.
Dietary Supplement: Nicotinamide Riboside (Niagen) Dietary Supplement: Placebo
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.
Dietary Supplement: Nicotinamide Riboside (Niagen) Dietary Supplement: Placebo

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. Ectopic lipid accumulation [ Time Frame: 6 weeks after supplementation ]
    Liver and skeletal muscle lipid accumulation measured with H-MRS in vivo.

  3. 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

  4. Cardiovascular risk parameters [ Time Frame: 6 weeks after supplementation ]
    Cardiac energy status measured with P-MRS.

  5. 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).

  6. Body composition [ Time Frame: 6 weeks after supplementation ]
    Fat mass and fat free mass measured with a BodPod.

  7. Acetylcarnitine levels [ Time Frame: 6 weeks after supplementation ]
    Skeletal muscle acetylcarnitine levels measured with H-MRS in vivo, before and after exercise stimulation (cycling).

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Ages Eligible for Study:   45 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02835664

Contact: Carlijn Remie, Msc 0031 43 3884596 carlijn.remie@maastrichtuniversity.nl
Contact: Patrick Schrauwen, PhD 0031 43 3881502 p.schrauwen@maastrichtuniversity.nl

Maastricht University Medical Centre Recruiting
Maastricht, Netherlands
Contact: Carlijn Remie, Msc         
Contact: Patrick Schrauwen, Prof.Dr.         
Sponsors and Collaborators
Maastricht University Medical Center
Dutch Heart Foundation
Principal Investigator: Patrick Schrauwen, PhD Maastricht University Medical Center

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02835664     History of Changes
Other Study ID Numbers: NL58119.068.16
First Posted: July 18, 2016    Key Record Dates
Last Update Posted: December 22, 2016
Last Verified: July 2016

Keywords provided by Maastricht University Medical Center:
Nicotinamide Riboside
Metabolic health
Insulin resistance
Mitochondrial function
Brown adipose tissue
Energy expenditure
Ectopic lipid accumulation
Cardiovascular risk

Additional relevant MeSH terms:
Nicotinic Acids
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents