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

NCT04874662 | Completed

• 1 other identifier: 20.07.CLI
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Muscle Injury

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Dietary Supplement: NAM/B6

Interventions

NAM/B6 DIETARY_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.

Investigational NAM/B6; Placebo control group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Subjects presenting with the following blood pressure (BP) and heart rate (HR) values at the screening visit after 10 minutes in supine position:
• mmHg ≤ systolic blood pressure (SBP) ≤ 140 mmHg,
• mmHg ≤ diastolic blood pressure (DBP) ≤ 95 mmHg,
• 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:
• \< 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;

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Bisepjerg-Frederiksbjerg Hospital

Copenhagen, Denmark

Location

Study Officials

• Michael Kjaer, Prof

  Institute of Sports Medicine, Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: randomized, double-blind, placebo-controlled, parallel group study

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 6, 2021
• Study Start: May 3, 2021
• Primary Completion: May 24, 2022
• Study Completion: May 24, 2022
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)