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

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ClinicalTrials.gov Identifier: NCT04664361
Recruitment Status : Recruiting
First Posted : December 11, 2020
Last Update Posted : March 23, 2021
Sponsor:
Collaborators:
CEN Nutriment
Centre d'Expertise de la Performance
LGD
Information provided by (Responsible Party):
Seneque SA

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.

Condition or disease Intervention/treatment Phase
Physical Activity Muscle Recovery Dietary Supplement: Nicotinamide mononucleotide Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized double-blind, placebo-controlled clinical trial conducted on 3 parallel groups
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Actual Study Start Date : March 9, 2021
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NMN 250
NMN tablet (250 mg)
Dietary Supplement: Nicotinamide mononucleotide
Daily supplementation with NMN at 250 and 500 mg for 38 days in total

Experimental: NMN 500
NMN tablet (500 mg)
Dietary Supplement: Nicotinamide mononucleotide
Daily supplementation with NMN at 250 and 500 mg for 38 days in total

Placebo Comparator: Placebo
NMN-free placebo tablet.
Other: Placebo
Daily supplementation with placebo for 38 days in total




Primary Outcome Measures :
  1. Evolution of muscle recovery [ Time Frame: before and after 21 and 38 days of treatment ]
    Wingate Anaerobic Test (WANT) preformed post-endurance test (at 85% maximum aerobic speed)


Secondary Outcome Measures :
  1. Changes in physical capacity [ Time Frame: before and after 21 and 38 days of treatment ]
    physical capacity evaluated during an endurance test (at 85% maximum aerobic speed) by the maximum duration (time limit)

  2. Changes in cardiorespiratory recovery [ Time Frame: before and after 21 and 38 days of treatment ]
    Measurement of blood pressure and heart rate at rest and at intervals of several minutes after the endurance test (at 85% maximum aerobic speed)

  3. Changes in the perception of the arduousness of the effort [ Time Frame: before and after 21 and 38 days of treatment ]
    evaluated by the Borg scale during the endurance test (at 85% maximum aerobic speed)

  4. Changes in blood lactate levels before and after physical exercise [ Time Frame: before and after 21 and 38 days of treatment ]
    blood lactate levels before and after the endurance test (at 85% maximum aerobic speed)

  5. Changes in the perception of the intensity of post-exercise muscle pain (cramps) [ Time Frame: before and after 21 and 38 days of treatment ]
    post-exercise muscular pain in evaluated using a 7 points numerical scale, 24, 48 and 72 hours after the endurance test

  6. Changes in the body composition [ Time Frame: before and after 21 and 38 days of treatment ]
    fat mass, muscle mass, visceral fat, water mass determined by Bioelectrical Impedance Analysis (BIA)

  7. Changes blood NAD+ levels [ Time Frame: before and after 21 and 38 days of treatment ]
    Evaluation of cellular NAD+ concentration in blood from baseline to the end of study



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Ages Eligible for Study:   20 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04664361


Contacts
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Contact: Florent Herpin +33 3 80 68 05 06 florent.herpin@groupecen.com
Contact: Laurent Laganier, PharmD +33 7 50 96 41 12 laurent.laganier@lgdfrance.com

Locations
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France
CEN Nutriment Recruiting
Dijon, France, 21000
Contact: Florent Herpin    03 80 68 05 06    florent.herpin@groupecen.com   
Principal Investigator: Nadege Plaza, MD         
Sponsors and Collaborators
Seneque SA
CEN Nutriment
Centre d'Expertise de la Performance
LGD
Investigators
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Principal Investigator: Nadège PLAZA, MD CEN Nutriment
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Responsible Party: Seneque SA
ClinicalTrials.gov Identifier: NCT04664361    
Other Study ID Numbers: C1598
First Posted: December 11, 2020    Key Record Dates
Last Update Posted: March 23, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seneque SA:
Nicotinamide mononucleotide
Muscle pain
Additional relevant MeSH terms:
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Niacinamide
Niacin
Nicotinic Acids
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents