Nicotinamide Mononucleotide Supplementation for Exercise Tolerance Improvement in Healthy Older Adults
NCT ID: NCT07144527
Last Updated: 2025-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
40 participants
INTERVENTIONAL
2025-09-15
2026-11-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
EGA® is composed of three metabolomic compounds that are endogenous to humans. The formulation has been used in prior exploratory studies and real-world applications, which have helped inform the design of this current trial.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of NMN on Muscle Recovery and Physical Capacity in Healthy Volunteers With Moderate Physical Activity
NCT04664361
Nicotinamide Riboside Supplementation and Exercise Training to Promote Healthy Longevity
NCT06425042
Role of Mitochondrial-derived Oxidative Stress to Promote Vascular Endothelial Dysfunction in Non-exercisers With Aging
NCT05872139
Effects of MIB-626 With and Without A High-Intensity Multi-Dimensional Exercise Training Program
NCT05878119
MitoQ & Cardiopulmonary Responses During Exercise
NCT06069245
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The primary endpoint is time to fatigue during constant work rate cycle ergometry (CWR-Tlim), a validated surrogate for submaximal exercise tolerance. Secondary endpoints include peak oxygen uptake (VO₂peak), lactate threshold, anaerobic work capacity, and critical power, in addition to circulating NAD⁺ and its related metabolites.
The trial is designed to evaluate the short-term physiological effects and biological activity of EGA® compared to conventional NMN under tightly controlled exercise testing and training conditions. Data from this study will be used to inform the therapeutic potential of EGA® in improving physical performance in healthy older adults (60-80 years). Future directions may include further clinical evaluation or regulatory submissions, depending on outcomes from this pilot investigation.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1 - EGA -> Placebo
Participants receive EGA during Period 1, followed by Placebo during Period 2 after a washout. Assigned Interventions: EGA; Placebo.
NMN, betaine, low-dose hydrogen peroxide (EGA)
Proprietary formulation containing NMN, betaine, and low-dose hydrogen peroxide.
Placebo
Organoleptically matched inert control.
Arm 2 - Placebo -> EGA
Participants receive Placebo during Period 1, followed by EGA during Period 2 after a washout. Assigned Interventions: Placebo; EGA.
NMN, betaine, low-dose hydrogen peroxide (EGA)
Proprietary formulation containing NMN, betaine, and low-dose hydrogen peroxide.
Placebo
Organoleptically matched inert control.
Arm 3 - NMN -> Placebo
Participants receive Nicotinamide Mononucleotide (NMN) during Period 1, followed by Placebo during Period 2 after a washout. Assigned Interventions: NMN; Placebo.
Nicotinamide Mononucleotide (NMN)
Conventional NMN supplement.
Placebo
Organoleptically matched inert control.
Arm 4 - Placebo -> NMN
Participants receive Placebo during Period 1, followed by NMN during Period 2 after a washout. Assigned Interventions: Placebo; NMN.
Nicotinamide Mononucleotide (NMN)
Conventional NMN supplement.
Placebo
Organoleptically matched inert control.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
NMN, betaine, low-dose hydrogen peroxide (EGA)
Proprietary formulation containing NMN, betaine, and low-dose hydrogen peroxide.
Nicotinamide Mononucleotide (NMN)
Conventional NMN supplement.
Placebo
Organoleptically matched inert control.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Free from acute or uncontrolled chronic medical conditions that would pose a risk or interfere with study participation
* Physically capable of engaging in structured exercise involving moderate to vigorous intensity stationary cycling
* Successful completion of a graded exercise test (e.g., stationary bike) without significant adverse events or contraindications
* Ability to attend at least four in-person laboratory visits in Beverly Hills, California
* Non-smoker for at least 12 months
* Able to provide informed consent and comply with study procedures
* Willing to refrain from initiating new exercise, dietary supplement, or medication regimens during the study
Exclusion Criteria
* 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
* Severe cognitive impairment preventing informed consent, protocol adherence, or comprehension of interventions
* Significant orthopedic limitations or injuries that prevent safe exercise participation
* Use of NMN, NR, or other NAD+-altering supplements within the past 14 weeks
* Anticipated or current alcohol consumption \>2 drinks per week, or unwillingness to abstain from alcohol during the study
* Current substance abuse affecting study participation or adherence
* Other acute or chronic health conditions judged by the investigators to pose risk or interfere with study objectives
* Non-compliance with study requirements, withdrawal of informed consent, or unforeseen circumstances compromising completion
* Any condition which, in the opinion of the investigator, would interfere with study participation or interpretation of results
60 Years
80 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Concordia University Chicago
OTHER
EGACeutical
UNKNOWN
Scott Silveira
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Scott Silveira
Principle Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical Office of Dr. Robert Huizenga MD
Beverly Hills, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2305604-1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.