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

Study Overview
=================
Brief Summary
-----------------
Assessment of safety and efficacy of NAM/B6 oral administration on the amplification and commitment of satellite cells after a muscle injury

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)

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).

Conditions
-----------------
Muscle Injury

Intervention / Treatment
-----------------
* Dietary Supplement: NAM/B6


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized, double-blind, placebo-controlled, parallel group study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Investigational NAM/B6<br>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 | Dietary Supplement: NAM/B6<br>* 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.<br>|
| Placebo Comparator: Placebo control group<br>2 capsules daily of microcrystalline cellulose excipient (337mg per capsule) Frequency and duration: 2 capsules daily for 9 days | Dietary Supplement: NAM/B6<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 9 days |