Effect of NMN on Muscle Recovery and Physical Capacity in Healthy Volunteers With Moderate Physical Activity

NCT04664361 | Completed DMC

• 1 other identifier: C1598
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect of NMN supplementation (250 and 500 mg/day over 38 days) compared to placebo in healthy volunteers with moderate physical activity on muscle recovery, physical capacity, cardiorespiratory recovery, the perception of the arduousness of the effort, the variation in blood lactate levels before and after physical exercise, the perception of the intensity of post-exercise muscle pain (cramps), the body composition and Nicotinamide-Adenine Mononucleotide (NAD+) level in blood.

Conditions

Physical Activity; Muscle Recovery

Keywords

Nicotinamide mononucleotide; Muscle pain

Outcome Measures

Primary Outcomes (1)

• Evolution of muscle recovery

  Wingate Anaerobic Test (WANT) preformed post-endurance test (at 85% maximum aerobic speed)

  before and after 21 and 38 days of treatment

Secondary Outcomes (7)

• Changes in physical capacity

  before and after 21 and 38 days of treatment

• Changes in cardiorespiratory recovery

  before and after 21 and 38 days of treatment

• Changes in the perception of the arduousness of the effort

  before and after 21 and 38 days of treatment

• Changes in blood lactate levels before and after physical exercise

  before and after 21 and 38 days of treatment

• Changes in the perception of the intensity of post-exercise muscle pain (cramps)

  before and after 21 and 38 days of treatment

Study Arms (3)

NMN 250

EXPERIMENTAL

NMN tablet (250 mg)

Dietary Supplement: Nicotinamide mononucleotide

NMN 500

EXPERIMENTAL

NMN tablet (500 mg)

Dietary Supplement: Nicotinamide mononucleotide

Placebo

PLACEBO COMPARATOR

NMN-free placebo tablet.

Other: Placebo

Interventions

Nicotinamide mononucleotide DIETARY_SUPPLEMENT

Daily supplementation with NMN at 250 and 500 mg for 38 days in total

NMN 250; NMN 500

Placebo OTHER

Daily supplementation with placebo for 38 days in total

Placebo

Eligibility Criteria

• Age: 20 Years - 49 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body Mass Index ranging from 20 to 28 kg/m2(bounds included);
• Body weight between of 70 kg to 100 kg (including limits);
• Able to provide written informed consent to participate;
• Having a moderate level of physical activity according to the Global Physical Activity Questionnaire (GPAQ);
• Having a sport practice involving endurance or split races (including collective or individual sports) or cycling.
• Agreeing not to change their physical activity habits throughout the study;

You may not qualify if:

• Having a mental state that does not allow them to give free and informed consent to participate in the study;
• Being taking regularly or have taken within the last month any medication or dietary supplement that may increase endurance, recovery, or physical capacity. In particular, the following drugs are strictly prohibited: beta-2 agonists such as salbutamol (Ventolin®), terbutaline (Bricanyl®), fenoterol (Berotec®), salmeterol (Serevent®) and formoterol (Foradil®) as well as corticosteroids;
• Having history of a recent (less than 3 months) lower extremity muscle injury;
• Presenting a depressive syndrome;
• Presenting an abnormal biological balance (Creatinine, Uric acid, Troponin, Alanine aminotransferase / Aspartate aminotransferase, Lactate dehydrogenase, Creatine Kinase, C-reactive protein, Transferrin, Bilirubin, Gamma Glutamyl transpeptidase, Cholesterol (EAL), Glycemia, Ionogram, Alkaline phosphatase );
• Being not be compliant with the constraints imposed by the protocol;
• Having an allergy or a contraindication to the components of the studied products;
• Being unable to understand, speak and read French fluently;
• Being not affiliated with a health insurance company;
• Being vulnerable persons or persons deprived of liberty by a judicial or administrative decision;
• Consuming illegal psychotropic substances or having an alcohol consumption of more than 2 glasses of alcohol/wine per day.

Sponsors & Collaborators

• Seneque SA: lead
• CEN Nutriment: collaborator
• Centre d'Expertise de la Performance: collaborator
• LGD: collaborator

Study Sites (1)

CEN Nutriment

Dijon, 21000, France

Location

MeSH Terms

Conditions

Motor Activity; Myalgia

Interventions

Nicotinamide Mononucleotide

Condition Hierarchy (Ancestors)

Behavior; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleotides; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Nadège PLAZA, MD

  CEN Nutriment

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Randomized double-blind, placebo-controlled clinical trial conducted on 3 parallel groups

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 11, 2020
• Study Start: March 9, 2021
• Primary Completion: November 10, 2022
• Study Completion: May 30, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Locations

FR (1)