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Completed

NCT Number: NCT02835664

Nicotinamide Riboside and Metabolic Health

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.

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Key information

Conditions

Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Centre

Maastricht, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nicotinamide Riboside (Niagen)

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  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 outcomes

  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 and Ambulatory blood pressure.

  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).

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Dutch Heart Foundation

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 18, 2016
Registry last updated
Mar 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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