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NCT Number: NCT03754842

Effect of Nicotinamide Riboside and Pterostilbene Supplementation on Muscle Regeneration in Elderly Humans

Successful skeletal muscle regeneration depends on a functional pool of muscle stem cells, termed satellite cells (SC). SC are in a quiescent state throughout adulthood, but undergo multiple cycles of proliferation and self-renewal in response to muscle damage. During aging, there is a loss of SC quiescence, and SC more readily enter an ageing-state impairing their function.

Animal studies have revealed a common denominator for increasing SC function and activity, namely Sirtuin activation. Natural stimulators of Sirtuins includes Nicotinamide Riboside (NR) (a Nicotinamide adenine dinucleotide (NAD+) precursor) and the polyphenol Pterostilbene (PT). In this study, we aim to investigate if NR+PT supplementation will promote skeletal muscle regeneration after muscle damage in elderly humans by enhanced recruitment of SC.

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Key information

Conditions

Muscle Injury

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital

Aarhus N, 8200, Denmark

About this study

14 days after start of placebo or NR/PT (500/100 mg twice daily) supplementation a muscle damage will induced in the m. vastus lat. by electric stimulation combined with eccentric work in a dynamometer. Muscle biopsies will be collected at 2 hours, 2, 8 and 30 days post damage and placebo or NR/PT supplementation will continue for the whole study period (45 days).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Written signed consent
  • Age: 55-80
  • BMI: 20-28 (kg/(m2))
  • Non-smoker

Exclusion criteria

  • Endocrine disease, neurological or muscle disease
  • Other severe disease
  • High daily activity level (>30 min / day)

Treatment and study plan

Placebo (twice daily)

Other

Matching placebo

Nicotinamide Riboside/Pterostilbene (500 mg/100 mg twice daily)

Other

Elysium Basis TM, Elysium Health, Inc., NY, USA

Primary outcomes

  1. Presence of Satellite Cells

    Time frame: Change from baseline up to 45 days

    quantified by immunohistochemistry in muscle biopsies

Secondary outcomes

  1. Activation of Satellite cells

    Time frame: Change from baseline up to 45 days

    determined by immunohistochemistry and FACS

  2. Presence of macrophages

    Time frame: Change from baseline up to 45 days

    determined by immunohistochemistry and FACS

  3. Presence of Fibro/Adipogenic Progenitors

    Time frame: Change from baseline up to 45 days

    quantified by FACS

  4. Presence of damaged muscle fibers

    Time frame: Change from baseline up to 45 days

    determined by immunohistochemistry

  5. Presence of muscle regenerative fibers

    Time frame: Change from baseline up to 45 days

    determined by immunohistochemistry

  6. Presence of autophagy in relation to muscle damage

    Time frame: Change from baseline up to 45 days

    determined by Western blot and PCR

  7. Lipid accumulation in skeletal muscle tissue and liver

    Time frame: Change from baseline to 8 days

    determined by magnetic resonance spectroscopy

  8. Blood glucose response in relation to muscle damage

    Time frame: Change from baseline to 8 days

    determined by Continuous glucose monitoring

  9. Body composition (lean body mass and fat body mass)

    Time frame: Change from baseline to 45 days

    measured by Dual energy X-ray absorptiometry

  10. Muscle strength

    Time frame: Change from baseline up to 45 days

    determined from maximal voluntary contraction of the m. quadriceps femoris

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • University of Copenhagen

Registry information

Official study title

Effect of Nicotinamide Riboside and Pterostilbene Supplementation on Muscle Regeneration in Elderly Humans - A Randomized, Placebo-controlled, Clinical Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 27, 2018
Registry last updated
Nov 5, 2020

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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