Nicotinamide Mononucleotide Supplementation for Exercise Tolerance Improvement in Healthy Older Adults

ConditionsAging Frailty Exercise Tolerance Healthy Male and Female Subjects

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age60-80

SponsorScott Silveira

About this trial

This is a randomized, double-blind, placebo-controlled, two-arm crossover clinical trial evaluating the effects of nicotinamide mononucleotide (NMN) combined with trimethylglycine (TMG) supplementation, compared to NMN alone. The study will assess safety and efficacy in improving exercise tolerance and modulating biomarkers of aging in healthy older adults.

The primary outcome is cycle ergometry constant work rate (CWR) exercise tolerance, measured as time to fatigue. Secondary outcomes include changes in peak oxygen consumption (VO₂peak), critical power, anaerobic work capacity, lactate threshold, and NAD⁺ metabolite levels.

The supplements have been used in prior exploratory studies and real-world applications, which have helped inform the design of this current trial.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults aged 60 to 80 years, of any sex

Written clearance from primary care physician confirming medical fitness to participate in an exercise-based clinical study

Normal or near-normal cardiovascular function to safely engage in moderate to vigorous exercise, demonstrated by either: stress echocardiogram or coronary CT angiogram within the past 12 months showing normal left ventricular function, no significant valvular heart disease, no ischemic changes, and no other clinically significant abnormalities, plus confirmation that no new cardiovascular symptoms (e.g., chest pain, dyspnea, syncope) or changes in health status have occurred since testing

Montreal Cognitive Assessment (MoCA) score of 26 or higher

Disqualifiers

Severe cardiovascular disease (e.g., recent myocardial infarction <6 months, unstable angina, uncontrolled hypertension >160/100 mmHg)

Severe respiratory conditions (e.g., advanced COPD or other conditions preventing exercise participation)

Significant neurological impairments that hinder comprehension of instructions or participation in exercise

Terminal illness or conditions limiting life expectancy or ability to complete the study

Trial design

Design model

Crossover

Treatments tested in this trial

NMN and TMG (Euexia)
Dietary supplement
Formulation containing NMN and TMG.
Nicotinamide Mononucleotide (NMN)
Dietary supplement
Conventional NMN supplement.
Placebo
Dietary supplement
Organoleptically matched inert control.

Treatment groups

40 Participants

are divided into 4 treatment groups

Group A: Arm 1 - NMN with TMG -> PlaceboExperimental treatment 2 interventions

Group B: Arm 2 - Placebo -> NMN with TMGExperimental treatment 2 interventions

Group C: Arm 3 - NMN -> PlaceboExperimental treatment 2 interventions

Group D: Arm 4 - Placebo -> NMNExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Time to Fatigue During Constant Work Rate Cycle Ergometry (tLIM).

Duration (in seconds) that participants can sustain a constant submaximal workload on a cycle ergometer until volitional fatigue. This is a validated surrogate for submaximal exercise tolerance.

Time frame

Measured at the beginning and end of each 4-week intervention period.

Secondary outcomes

Peak Oxygen Uptake (VO2max)

Maximum oxygen consumption (ml/kg/min) achieved during graded exercise testing.

Time frame

Measured at the beginning and end of each 4-week intervention period.

Lactate Threshold

Workload or oxygen consumption corresponding to the point at which blood lactate concentration rises above baseline, assessed via graded exercise testing and gas exchange sampling.

Time frame

Measured at the beginning and end of each 4-week intervention period.

Anaerobic Work Capacity

Cumulative work performed above the critical power, calculated from cycle ergometer testing.

Time frame

Measured at the beginning and end of each 4-week intervention period.

Critical Power

The asymptote of the power-duration relationship. A work rate reflecting sustainable aerobic work capacity.

Time frame

Measured at the beginning and end of each 4-week intervention period.

Other outcomes

Adverse Events

Incidence of any reported adverse events or side effects during intervention periods.

Time frame

From first dose through final study visit (up to 12 weeks per participant, including two 4-week intervention periods and a 4-week washout).

Adherence to Supplementation

Pill counts and participant self-report logs of study product usage.

Time frame

Assessed weekly during each 4-week intervention period and at the end of each intervention period (Weeks 4 and 12), for a total study duration of up to 12 weeks per participant.

Exercise Session Adherence

Proportion of prescribed exercise sessions completed (percentage of sessions completed (%) per intervention period, verified by attendance log.

Time frame

Assessed weekly during each 4-week intervention period and summarized at the end of each period (Weeks 4 and 12); total study duration up to 12 weeks per participant.

Fasting Plasma Homocysteine Levels

Fasting plasma homocysteine levels will be assessed using a standardized commercial laboratory assay (LabCorp) from venous blood samples. Values will be reported in micromoles per liter (µmol/L).

Time frame

Measured at the beginning and end of each 4-week intervention period.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Scott Silveira

Lead sponsor

Concordia University Chicago

Sponsor institution

Concordia University Chicago

Collaborator

Source ClinicalTrials.gov

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