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Completed

NCT Number: NCT02303483

The Effect of Vitamin B3 on Substrate Metabolism, Insulin Sensitivity, and Body Composition in Obese Men

In animals, treatment with vitamin B3 improved insulin sensitivity and substrate metabolism. It is currently not know if vitamin B3 has the same positive effects in humans. In the current study the effect of a 3 month treatment with vitamin B3 on insulin sensitivity and substrate metabolism in obese men will be investigated.

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Key information

Conditions

Obese Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Medical Research Laboratories, Aarhus University Hospital

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • written signed consent
  • male
  • BMI>30 kg/(m2)
  • age: 40-70
  • no medication
  • non-smoker

Exclusion criteria

  • endocrine disease
  • other severe disease
  • high daily activity level (>30 min / day)

Treatment and study plan

Nicotinamide riboside (NIAGEN TM, ChromaDex, CA, USA )

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. Insulin sensitivity

    Time frame: Change from baseline in insulin sensitivity at 3 months

    determined by a hyperinsulineamic clamp

Secondary outcomes

  1. Substrate metabolism

    Time frame: Change from baseline in substrate metabolism at 3 months

    measured by indirect calorimetry

  2. body composition

    Time frame: Change from baseline in body composition at 3 months

    measured by DEXA scan

  3. Activation of satellite cells

    Time frame: Change from baseline in activation of satellite cells at 3 months

    measured by immunohistochemestry

  4. lipid accumulation in liver and skeletal muscle tissue

    Time frame: Change from baseline in liver and muscle lipid content at 3 months

    determined by MR-spectroscopy

  5. glucose turnover

    Time frame: Change from baseline in glucose turnover at 3 months

    determined by glucose tracer techniques

  6. insulin signalling in skeletal muscle and adipose tissue biopsies

    Time frame: Change from baseline in insulin signaling at 3 months

    western blotting

  7. Palmitate turnover

    Time frame: Change from baseline in palmitate turnover at 3 months

    determined by palmitate tracer techniques

  8. Gut microbiota

    Time frame: Change from baseline in composition of gut microbiota at 3 months

    Intestinal bacteria composition by whole genome sequencing

  9. Incretin hormone secretion

    Time frame: Change from baseline in incretion hormone secretion at 3 months

    Determined by measurement of incretin homones during an oral glucose tolerance test (OGTT)

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • University of Copenhagen

Registry information

Official study title

The Effect of Nicotinamide Ribose (NR) on Substrate Metabolism, Insulin Sensitivity, and Body Composition in Obese Men - a Randomized, Placebo Controlled Clinical Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 1, 2014
Registry last updated
Jul 2, 2017

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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