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

Muscle Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03754842
• Other study ID #: AU2018-11-19
• Status: Completed
• Phase: N/A
• Start date: February 12, 2019
• Est. completion date: September 1, 2020

Study information

• Verified date: March 2020
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Muscle Injury

Intervention

Other:
• Placebo (twice daily)
Matching placebo
• Nicotinamide Riboside/Pterostilbene (500 mg/100 mg twice daily)
Elysium Basis TM, Elysium Health, Inc., NY, USA

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus N

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of Satellite Cells	quantified by immunohistochemistry in muscle biopsies	Change from baseline up to 45 days
Secondary	Activation of Satellite cells	determined by immunohistochemistry and FACS	Change from baseline up to 45 days
Secondary	Presence of macrophages	determined by immunohistochemistry and FACS	Change from baseline up to 45 days
Secondary	Presence of Fibro/Adipogenic Progenitors	quantified by FACS	Change from baseline up to 45 days
Secondary	Presence of damaged muscle fibers	determined by immunohistochemistry	Change from baseline up to 45 days
Secondary	Presence of muscle regenerative fibers	determined by immunohistochemistry	Change from baseline up to 45 days
Secondary	Presence of autophagy in relation to muscle damage	determined by Western blot and PCR	Change from baseline up to 45 days
Secondary	Lipid accumulation in skeletal muscle tissue and liver	determined by magnetic resonance spectroscopy	Change from baseline to 8 days
Secondary	Blood glucose response in relation to muscle damage	determined by Continuous glucose monitoring	Change from baseline to 8 days
Secondary	Body composition (lean body mass and fat body mass)	measured by Dual energy X-ray absorptiometry	Change from baseline to 45 days
Secondary	Muscle strength	determined from maximal voluntary contraction of the m. quadriceps femoris	Change from baseline up to 45 days