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

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ClinicalTrials.gov Identifier: NCT03754842
Recruitment Status : Recruiting
First Posted : November 27, 2018
Last Update Posted : March 26, 2019
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Muscle Injury Other: Placebo (twice daily) Other: Nicotinamide Riboside/Pterostilbene (500 mg/100 mg twice daily) Not Applicable

Detailed Description:
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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Nicotinamide Riboside and Pterostilbene Supplementation on Muscle Regeneration in Elderly Humans - A Randomized, Placebo-controlled, Clinical Trial
Actual Study Start Date : February 12, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Other: Placebo (twice daily)
Matching placebo

Experimental: Nicotinamide Riboside + Pterostilbene Other: Nicotinamide Riboside/Pterostilbene (500 mg/100 mg twice daily)
Elysium Basis TM, Elysium Health, Inc., NY, USA




Primary Outcome Measures :
  1. Presence of Satellite Cells [ Time Frame: Change from baseline up to 45 days ]
    quantified by immunohistochemistry in muscle biopsies


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

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): NCT03754842


Contacts
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Contact: Jonas B. Jensen 0045 40952577 jonj@biomed.au.dk
Contact: Niels Jessen 0045 28596352

Locations
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Denmark
Aarhus University Hospital Recruiting
Aarhus N, Denmark, 8200
Contact: Jonas Jensen, MD         
Sponsors and Collaborators
University of Aarhus
University of Copenhagen

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03754842     History of Changes
Other Study ID Numbers: AU2018-11-19
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Niacinamide
Niacin
Nicotinic Acids
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents