Skip to main content
OpenTrials
Completed

NCT Number: NCT04664361

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–49 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

CEN Nutriment

Dijon, 21000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nicotinamide mononucleotide

Dietary Supplement

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

Placebo

Other

Daily supplementation with placebo for 38 days in total

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Seneque SA

Industry

Collaborators

  • CEN Nutriment
  • Centre d'Expertise de la Performance
  • LGD

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Dec 11, 2020
Registry last updated
Jan 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.