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

NCT ID: NCT04664361

Last Updated: 2024-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-09
• Study Completion Date: 2023-05-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

NMN 250

NMN tablet (250 mg)

Group Type: EXPERIMENTAL

Nicotinamide mononucleotide

Intervention Type: DIETARY_SUPPLEMENT

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

NMN 500

NMN tablet (500 mg)

Group Type: EXPERIMENTAL

Nicotinamide mononucleotide

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

NMN-free placebo tablet.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Daily supplementation with placebo for 38 days in total

Interventions

Nicotinamide mononucleotide

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Daily supplementation with placebo for 38 days in total

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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;

Exclusion Criteria

• 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, in the opinion of the investigator, any symptomatology, pathology or cardiovascular risk factors that are incompatible with the conduct of the study or with the performance of a stress test or that could influence the results of the study, and in particular: 1) an abnormal resting and/or stress ECG at the inclusion visit according to the investigator; 2) presence of abnormalities in the lipid balance (Total Cholesterol, Triglycerides, HDL, LDL), blood glucose, and/or hemodynamic parameters;
• 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 already involved in another clinical trial or being in the exclusion period of a previous clinical trial;
• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

CEN Nutriment

UNKNOWN

Sponsor Role: collaborator

Centre d'Expertise de la Performance

UNKNOWN

Sponsor Role: collaborator

LGD

INDUSTRY

Sponsor Role: collaborator

Seneque SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nadège PLAZA, MD

Role: PRINCIPAL_INVESTIGATOR

CEN Nutriment

Locations

CEN Nutriment

Dijon, , France

Countries

France

Other Identifiers

C1598

Identifier Type: -

Identifier Source: org_study_id