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

Study Overview
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Brief Summary
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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.

Official Title
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Randomized, Double-blind, Placebo-controlled Clinical Trial of Nicotinamide Mononucleotide on Muscle Recovery and Physical Capacity in Healthy Volunteers With Moderate Physical Activity

Conditions
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Physical Activity, Muscle Recovery

Intervention / Treatment
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* Dietary Supplement: Nicotinamide mononucleotide
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized double-blind, placebo-controlled clinical trial conducted on 3 parallel groups
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NMN 250<br>NMN tablet (250 mg) | Dietary Supplement: Nicotinamide mononucleotide<br>* Daily supplementation with NMN at 250 and 500 mg for 38 days in total<br>|
| Experimental: NMN 500<br>NMN tablet (500 mg) | Dietary Supplement: Nicotinamide mononucleotide<br>* Daily supplementation with NMN at 250 and 500 mg for 38 days in total<br>|
| Placebo Comparator: Placebo<br>NMN-free placebo tablet. | Other: Placebo<br>* Daily supplementation with placebo for 38 days in total<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in physical capacity | physical capacity evaluated during an endurance test (at 85% maximum aerobic speed) by the maximum duration (time limit) | before and after 21 and 38 days of treatment | 
| Changes in cardiorespiratory recovery | Measurement of blood pressure and heart rate at rest and at intervals of several minutes after the endurance test (at 85% maximum aerobic speed) | before and after 21 and 38 days of treatment | 
| Changes in the perception of the arduousness of the effort | evaluated by the Borg scale during the endurance test (at 85% maximum aerobic speed) | before and after 21 and 38 days of treatment | 
| Changes in blood lactate levels before and after physical exercise | blood lactate levels before and after the endurance test (at 85% maximum aerobic speed) | before and after 21 and 38 days of treatment | 
| Changes in the perception of the intensity of post-exercise muscle pain (cramps) | post-exercise muscular pain in evaluated using a 7 points numerical scale, 24, 48 and 72 hours after the endurance test | before and after 21 and 38 days of treatment | 
| Changes in the body composition | fat mass, muscle mass, visceral fat, water mass determined by Bioelectrical Impedance Analysis (BIA) | before and after 21 and 38 days of treatment | 
| Changes blood NAD+ levels | Evaluation of cellular NAD+ concentration in blood from baseline to the end of study | before and after 21 and 38 days of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nicotinamide mononucleotide, Muscle pain