Muscle InjuryNCT03754842
Effect of Nicotinamide Riboside and Pterostilbene Supplementation on Muscle Regeneration in Elderly Humans
A study testing Nicotinamide Riboside/Pterostilbene (500 mg/100 mg twice daily) in people with Muscle Injury, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Injury
- What is being tested?
- Nicotinamide Riboside/Pterostilbene (500 mg/100 mg twice daily)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Feb 2019to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written signed consent
- Age: 55-80
- BMI: 20-28 (kg/(m2))
- Non-smoker
Who cannot join
- Endocrine disease, neurological or muscle disease
- Other severe disease
- High daily activity level (>30 min / day)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Nicotinamide Riboside and Pterostilbene Supplementation on Muscle Regeneration in Elderly Humans - A Randomized, Placebo-controlled, Clinical Trial
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.
Read the 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).
- Conditions
- Muscle Injury
- Being tested
- Placebo (twice daily), Nicotinamide Riboside/Pterostilbene (500 mg/100 mg twice daily)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo (twice daily)Other
Matching placebo
Nicotinamide Riboside/Pterostilbene (500 mg/100 mg twice daily)Other
Elysium Basis TM, Elysium Health, Inc., NY, USA
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Other: Placebo (twice daily) |
| Nicotinamide Riboside + Pterostilbene | Experimental | Not described Receives: Other: Nicotinamide Riboside/Pterostilbene (500 mg/100 mg twice daily) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Satellite Cells
quantified by immunohistochemistry in muscle biopsies
Measured: Change from baseline up to 45 days
Secondary outcomes (10)
Activation of Satellite cells
determined by immunohistochemistry and FACS
Measured: Change from baseline up to 45 days
Presence of macrophages
determined by immunohistochemistry and FACS
Measured: Change from baseline up to 45 days
Presence of Fibro/Adipogenic Progenitors
quantified by FACS
Measured: Change from baseline up to 45 days
Presence of damaged muscle fibers
determined by immunohistochemistry
Measured: Change from baseline up to 45 days
Presence of muscle regenerative fibers
determined by immunohistochemistry
Measured: Change from baseline up to 45 days
Presence of autophagy in relation to muscle damage
determined by Western blot and PCR
Measured: Change from baseline up to 45 days
Lipid accumulation in skeletal muscle tissue and liver
determined by magnetic resonance spectroscopy
Measured: Change from baseline to 8 days
Blood glucose response in relation to muscle damage
determined by Continuous glucose monitoring
Measured: Change from baseline to 8 days
Body composition (lean body mass and fat body mass)
measured by Dual energy X-ray absorptiometry
Measured: Change from baseline to 45 days
Muscle strength
determined from maximal voluntary contraction of the m. quadriceps femoris
Measured: Change from baseline up to 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start12 Feb 2019
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle InjuryStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754842
- Sponsor's protocol ID
- AU2018-11-19
- Status last verified
- Mar 2020
- First submitted
- 19 Nov 2018
- Last updated
- 5 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35998039
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nicotinamide Riboside and Pterostilbene Supplementation on Muscle Regeneration in Elderly Humans - A Randomized, Placebo-controlled, Clinical Trial
- ClinicalTrials.gov ID
- NCT03754842
- Acronym / sponsor ID
- AU2018-11-19
- Conditions
- Muscle Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 27 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo (twice daily) |
| Nicotinamide Riboside + Pterostilbene | Experimental | Other: Nicotinamide Riboside/Pterostilbene (500 mg/100 mg twice daily) |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written signed consent
- Age: 55-80
- BMI: 20-28 (kg/(m2))
- Non-smoker
Key exclusion criteria (3 listed)
- Endocrine disease, neurological or muscle disease
- Other severe disease
- High daily activity level (>30 min / day)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo (twice daily)Matching placebo | Other | Placebo |
| Nicotinamide Riboside/Pterostilbene (500 mg/100 mg twice daily)Elysium Basis TM, Elysium Health, Inc., NY, USA | Other | Nicotinamide Riboside + Pterostilbene |
Primary outcome
Presence of Satellite Cells
Time frame: Change from baseline up to 45 days
quantified by immunohistochemistry in muscle biopsies
10 secondary outcomes
Activation of Satellite cells
Time frame: Change from baseline up to 45 days
Presence of macrophages
Time frame: Change from baseline up to 45 days
Presence of Fibro/Adipogenic Progenitors
Time frame: Change from baseline up to 45 days
Presence of damaged muscle fibers
Time frame: Change from baseline up to 45 days
Presence of muscle regenerative fibers
Time frame: Change from baseline up to 45 days
Presence of autophagy in relation to muscle damage
Time frame: Change from baseline up to 45 days
Lipid accumulation in skeletal muscle tissue and liver
Time frame: Change from baseline to 8 days
Blood glucose response in relation to muscle damage
Time frame: Change from baseline to 8 days
Body composition (lean body mass and fat body mass)
Time frame: Change from baseline to 45 days
Muscle strength
Time frame: Change from baseline up to 45 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Derived from this study: PubMed 35998039Jensen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotinamide Riboside/Pterostilbene (500 mg/100 mg twice daily) in people with Muscle Injury, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Satellite Cells (time frame: Change from baseline up to 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03754842, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.