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

Randomized, Double-blind, Placebo-controlled Clinical Trial of Nicotinamide Mononucleotide 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.

Study Overview

• Status: Completed
• Conditions: Physical Activity; Muscle Recovery
• Intervention / Treatment: Dietary supplement: Nicotinamide mononucleotide; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 131
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Florent Herpin; Phone Number: +33 3 80 68 05 06; Email: florent.herpin@groupecen.com
• Study Contact Backup: Name: Laurent Laganier, PharmD; Phone Number: +33 7 50 96 41 12; Email: laurent.laganier@lgdfrance.com

Study Locations

• France
  • Dijon, France, 21000
    • CEN Nutriment

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seneque SA
• Collaborators: CEN Nutriment; LGD; Centre d'Expertise de la Performance
• Investigators: Principal Investigator: Nadège PLAZA, MD, CEN Nutriment

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2021
• Primary Completion (Actual): November 10, 2022
• Study Completion (Actual): May 30, 2023

Study Registration Dates

• First Submitted: December 10, 2020
• First Submitted That Met QC Criteria: December 10, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 15, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Muscle pain; Nicotinamide mononucleotide
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Antimetabolites; Micronutrients; Hypolipidemic Agents; Lipid Regulating Agents; Vitamins; Vitamin B Complex; Nicotinic Acids; Niacinamide; Niacin
• Other Study ID Numbers: C1598

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No