Clinical trial NCT04664361: Effect of NMN on Muscle Recovery and Physical Capacity in Healthy Volunteers With Moderate Physical Activity
Official title: Randomized, Double-blind, Placebo-controlled Clinical Trial of Nicotinamide Mononucleotide on Muscle Recovery and Physical Capacity in Healthy Volunteers With Moderate Physical Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Muscle Recovery
Keywords: Nicotinamide mononucleotide
Muscle pain
Lead sponsor: Seneque SA
Sponsor class: INDUSTRY
Collaborators: name: CEN Nutriment
name: Centre d'Expertise de la Performance
name: LGD
First posted: 2020-12-11
Enrollment: 131
Sex: MALE
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized double-blind, placebo-controlled clinical trial conducted on 3 parallel groups
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Evolution of muscle recovery
timeFrame: before and after 21 and 38 days of treatment
Secondary outcomes:
measure: Changes in physical capacity
timeFrame: before and after 21 and 38 days of treatment
measure: Changes in cardiorespiratory recovery
timeFrame: before and after 21 and 38 days of treatment
measure: Changes in the perception of the arduousness of the effort
timeFrame: before and after 21 and 38 days of treatment
measure: Changes in blood lactate levels before and after physical exercise
timeFrame: before and after 21 and 38 days of treatment
measure: Changes in the perception of the intensity of post-exercise muscle pain (cramps)
timeFrame: before and after 21 and 38 days of treatment
measure: Changes in the body composition
timeFrame: before and after 21 and 38 days of treatment
measure: Changes blood NAD+ levels
timeFrame: before and after 21 and 38 days of treatment
Other outcomes:
Locations:
city: Dijon
country: France
facility: CEN Nutriment
Study officials:
affiliation: CEN Nutriment
name: Nadège PLAZA, MD
role: PRINCIPAL_INVESTIGATOR
References: