NCT03754842

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

February 12, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

November 5, 2020

Status Verified

March 1, 2020

Enrollment Period

1.6 years

First QC Date

November 19, 2018

Last Update Submit

November 4, 2020

Conditions

Muscle Injury

Outcome Measures

Primary Outcomes (1)

  • Presence of Satellite Cells

    quantified by immunohistochemistry in muscle biopsies

    Change from baseline up to 45 days

Secondary Outcomes (10)

  • Activation of Satellite cells

    Change from baseline up to 45 days

  • Presence of macrophages

    Change from baseline up to 45 days

  • Presence of Fibro/Adipogenic Progenitors

    Change from baseline up to 45 days

  • Presence of damaged muscle fibers

    Change from baseline up to 45 days

  • Presence of muscle regenerative fibers

    Change from baseline up to 45 days

  • +5 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Other: Placebo (twice daily)

Nicotinamide Riboside + Pterostilbene

EXPERIMENTAL
Other: Nicotinamide Riboside/Pterostilbene (500 mg/100 mg twice daily)

Interventions

Placebo (twice daily)OTHER

Matching placebo

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

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

Nicotinamide Riboside + Pterostilbene

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus N, 8200, Denmark

Location

Related Publications (1)

  • Jensen JB, Dollerup OL, Moller AB, Billeskov TB, Dalbram E, Chubanava S, Damgaard MV, Dellinger RW, Trost K, Moritz T, Ringgaard S, Moller N, Treebak JT, Farup J, Jessen N. A randomized placebo-controlled trial of nicotinamide riboside and pterostilbene supplementation in experimental muscle injury in elderly individuals. JCI Insight. 2022 Oct 10;7(19):e158314. doi: 10.1172/jci.insight.158314.

    PMID: 35998039DERIVED

MeSH Terms

Interventions

nicotinamide-beta-ribosidePterocarpus marsupium

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2018

First Posted

November 27, 2018

Study Start

February 12, 2019

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

November 5, 2020

Record last verified: 2020-03

Locations

DK(1)