NCT04874662

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

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").

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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)

Conditions

• Muscle Injury

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	NAM/B6	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.

Timeline

• Start date: 2021-05-03
• Primary completion: 2022-05-24
• Completion: 2022-05-24
• First posted: 2021-05-06
• Last updated: 2024-10-31

Locations

1 site across 1 country: Denmark