Muscle InjuryNCT04874662

Nicotinamide (NAM) and Pyridoxine (vitamin B6) on Muscle Regeneration ("Satellite-01 Study").

A study testing NAM/B6 in people with Muscle Injury, run by Société des Produits Nestlé (SPN) at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Assessment of safety and efficacy of NAM/B6 oral administration on the amplification and commitment of satellite cells after a muscle injury Read more about this study

Who is it for?: Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Muscle Injury
What is being tested?: NAM/B6
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteDenmark
Study dates: 3 May 2021to 24 May 2022
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 18 to 50 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Males aged ≥18 ≤ 50 years;
Subjects must be in good general health, as determined by the investigator or delegate, based on a comprehensive medical evaluation at screening including detailed medical history, full physical examination, blood pressure and heart rate measurements, 12-lead electrocardiogram (ECG) and clinical laboratory tests;
Body mass index (BMI) between18.5 and 24.9 kg/m2;
Normal dietary habits;
Willing to adhere to the prohibitions and restrictions specified in the protocol;
Must understand the nature of the study and be capable of giving written informed consent and be willing to report for the scheduled study visits and communicate to study personnel about adverse events and concomitant medication use.

Who cannot join

Subjects presenting with the following blood pressure (BP) and heart rate (HR) values at the screening visit after 10 minutes in supine position:
95 mmHg ≤ systolic blood pressure (SBP) ≤ 140 mmHg,
50 mmHg ≤ diastolic blood pressure (DBP) ≤ 95 mmHg,
50 bpm < HR < 80 bpm,
Or any other out of expected range values considered clinically significant by the investigator;
Screening visit 12-lead ECG values which are:

Show all 26Show fewer

120 < PR segment < 220 ms,
QRS complex < 120 ms,
QTcf < 430 ms,
Sign of any trouble of sinusal automatism,
Or any other ECG finding considered clinically significant by the investigator;
Have any clinically significant abnormalities in serum chemistry, hematology, or urinalysis at screening as judged by the investigator or delegate;
Active smokers;
Vegetarians or vegans;
Performed structured exercises within 3 months prior to participation in the study;
History or current use of anabolic steroids and/or growth hormone;
Use of corticosteroids within 3 months prior to participation in the study;
Current use of anticoagulant or anti-aggreging agents;
History or current use since 2 weeks before inclusion of any of the prohibited medications as detailed in Section 6.6.2;
History or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, musculoskeletal, psychiatric, systemic or infectious disease;
History or current use of drugs or alcohol (alcohol consumption > 40 grams/day);
Known intolerance to foods containing the ingredients under investigation;
Knee pain that prevents application of the electrical muscle stimulation protocol;
Subjects who, in the judgment of the investigator, are likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development;
Subjects under administrative or legal supervision;
Have participated in a clinical study in the last 3 months and received compensation beyond a certain approved and predefined limit.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Bisepjerg-Frederiksbjerg Hospital
Copenhagen

Other trials in Denmark

About this study

Official title: Efficacy and Safety of a Mix of Nicotinamide (NAM) and Pyridoxine (vitamin B6) on Muscle Regeneration: a Randomized, Double-blind, Placebo-controlled Study ("Satellite-01 Study").

Assessment of safety and efficacy of NAM/B6 oral administration on the amplification and commitment of satellite cells after a muscle injury

Read the detailed description

NAM/B6 oral administration after a muscle injury ("Satellite-01 study"): Effect on satellite cells as measured by immunofluorescence (Pax7 and myogenin antibodies to detect amplifying and committed satellite cells, respectively) on sections of muscle biopsies from the stimulated leg (leg 2) by muscle biopsies, comparing the study intervention (NAM/B6) to the control intervention (placebo)

Conditions: Muscle Injury
Being tested: NAM/B6

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NAM/B6Dietary supplement
Single daily dose administration will take place from Day 0 (V1) to Day 8 (V4) around 8 am after an overnight fast from the subsequent evening at 9 pm.

Study groups in NCT04874662
Study group	Role	What they receive
Investigational NAM/B6	Active comparator	2 VCaps® capsules daily (commercial vegetarian capsules made of Hydroxy Propyl Methyl Cellulose, a polymer of cellulose) Dosage per capsule: 357mg of nicotinamide, 9.5mg of pyridoxine and 195mg of microcrystalline cellulose Form:The VCaps® Size 00 will be used. They have a volume of 0.95 ml for 23.3 mm length and a diameter of 8.51 mm head / 8.16 mm body.daily of NAM/B6 Frequency and duration: 2 capsules daily for 9 days Receives: Dietary Supplement: NAM/B6
Placebo control group	Placebo comparator	2 capsules daily of microcrystalline cellulose excipient (337mg per capsule) Frequency and duration: 2 capsules daily for 9 days Receives: Dietary Supplement: NAM/B6

What is being measured

The primary outcome is the main question the study is designed to answer.

immunofluorescence measurement
Number of satellite cells as measured by immunofluorescence (Pax7 and myogenin antibodies to detect amplifying and committed satellite cells, respectively) on sections of muscle biopsies from the stimulated leg (leg 2) at day 4 and day 8 (muscle biopsies: MB3 and MB5), comparing the study intervention (NAM/B6) to the control intervention (placebo)
Measured: 9 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 May 202124 May 2022

First posted6 May 2021
Study start3 May 2021
Primary completion24 May 2022
Study completion24 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Muscle InjuryStudies of the same condition, open and under way.
More trials run by Société des Produits Nestlé (SPN)The 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: randomized, double-blind, placebo-controlled, parallel group study
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04874662
Sponsor's protocol ID: 20.07.CLI
Status last verified: Oct 2024
First submitted: 4 May 2021
Last updated: 31 Oct 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
RecruitingPhase 4
Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
Centreal Neurological Condition, Acquired Brain Injury (Including Stroke)
Not yet recruiting
Neuromuscular Electrical Stimulation to Improve the Muscle Health of Individuals With Acute Kidney Injury
Acute Kidney Injury, Acute Kidney Injury KDIGO 2
RecruitingPhase 2
Extracorporeal Shockwave Therapy as an Additional Treatment for Spasticity Secondary to Spinal Cord Injury
Spinal Cord Injury, Spasticity

All Muscle Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of a Mix of Nicotinamide (NAM) and Pyridoxine (vitamin B6) on Muscle Regeneration: a Randomized, Double-blind, Placebo-controlled Study ("Satellite-01 Study").
ClinicalTrials.gov ID: NCT04874662
Acronym / sponsor ID: 20.07.CLI
Conditions: Muscle Injury
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
Study start: 3 May 2021 (actual)
Primary completion: 24 May 2022 (actual)
Study completion: 24 May 2022 (actual)
First posted: 6 May 2021 (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.

Assessment of safety and efficacy of NAM/B6 oral administration on the amplification and commitment of satellite cells after a muscle injury

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: randomized, double-blind, placebo-controlled, parallel group study

Arm	Type	Receives
Investigational NAM/B6	Active comparator	Dietary Supplement: NAM/B62 VCaps® capsules daily (commercial vegetarian capsules made of Hydroxy Propyl Methyl Cellulose, a polymer of cellulose) Dosage per capsule: 357mg of nicotinamide, 9.5mg of pyridoxine and 195mg of microcrystalline cellulose Form:The VCaps® Size 00 will be used. They have a volume of 0.95 ml for 23.3 mm length and a diameter of 8.51 mm head / 8.16 mm body.daily of NAM/B6 Frequency and duration: 2 capsules daily for 9 days
Placebo control group	Placebo comparator	Dietary Supplement: NAM/B62 capsules daily of microcrystalline cellulose excipient (337mg per capsule) Frequency and duration: 2 capsules daily for 9 days

Who may qualify

Ages: 18 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Males aged ≥18 ≤ 50 years;
Subjects must be in good general health, as determined by the investigator or delegate, based on a comprehensive medical evaluation at screening including detailed medical history, full physical examination, blood pressure and heart rate measurements, 12-lead electrocardiogram (ECG) and clinical laboratory tests;
Body mass index (BMI) between18.5 and 24.9 kg/m2;
Normal dietary habits;
Willing to adhere to the prohibitions and restrictions specified in the protocol;

Key exclusion criteria (26 listed)

Subjects presenting with the following blood pressure (BP) and heart rate (HR) values at the screening visit after 10 minutes in supine position:
Screening visit 12-lead ECG values which are:
Have any clinically significant abnormalities in serum chemistry, hematology, or urinalysis at screening as judged by the investigator or delegate;
Active smokers;
Vegetarians or vegans;

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
NAM/B6Single daily dose administration will take place from Day 0 (V1) to Day 8 (V4) around 8 am after an overnight fast from the subsequent evening at 9 pm.	Dietary supplement	Investigational NAM/B6, Placebo control group

Primary outcome

immunofluorescence measurement
Time frame: 9 days
Number of satellite cells as measured by immunofluorescence (Pax7 and myogenin antibodies to detect amplifying and committed satellite cells, respectively) on sections of muscle biopsies from the stimulated leg (leg 2) at day 4 and day 8 (muscle biopsies: MB3 and MB5), comparing the study intervention (NAM/B6) to the control intervention (placebo)

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 31 Oct 2024.
Individual participant dataSharing planned: No

Related trials for Muscle Injury

Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
RecruitingPhase 4
Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
Centreal Neurological Condition, Acquired Brain Injury (Including Stroke)
Not yet recruiting
Neuromuscular Electrical Stimulation to Improve the Muscle Health of Individuals With Acute Kidney Injury
Acute Kidney Injury, Acute Kidney Injury KDIGO 2
RecruitingPhase 2
Extracorporeal Shockwave Therapy as an Additional Treatment for Spasticity Secondary to Spinal Cord Injury
Spinal Cord Injury, Spasticity

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.

Michael Kjaer, Prof principal investigator

Institute of Sports Medicine, Copenhagen

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing NAM/B6 in people with Muscle Injury, run by Société des Produits Nestlé (SPN) 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 6 inclusion and 26 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 31 Oct 2024. 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?

immunofluorescence measurement (time frame: 9 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 NCT04874662.

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 31 Oct 2024.