RECRUITING

Nicotinamide Mononucleotide Supplementation for Exercise Tolerance Improvement in Healthy Older Adults

Conditions

Aging Frailty Exercise Tolerance Healthy Male and Female Subjects Nicotinamide Mononucleotide NAD+ Metabolism Older Adults Betaine Hydrogen Peroxide (low-dose, dietary)High Intensity Interval Training VO2peak Lactate Threshold Critical Power Anaerobic Work Capacity Healthy Volunteers

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a randomized, double-blind, placebo-controlled, two-arm crossover clinical trial evaluating the effects of a patented age-reversal therapy, EGA®, compared to conventional nicotinamide mononucleotide (NMN) supplementation. 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. 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.

Official Title

Nicotinamide Mononucleotide Supplementation for Exercise Tolerance Improvement in Healthy Older Adults

Quick Facts

Study Start:2025-09-15

Study Completion:2026-11-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07144527

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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 * 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	* 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 * 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

Inclusion Criteria

Exclusion Criteria

* 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
* 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

* 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
* 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

Contacts and Locations

Study Locations (Sites)

Medical Office of Dr. Robert Huizenga MD

Beverly Hills, California, 90210

United States

Collaborators and Investigators

Sponsor: Scott Silveira

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-15

Study Completion Date2026-11-01

Study Record Updates

Study Start Date2025-09-15

Study Completion Date2026-11-01

Terms related to this study

Keywords Provided by Researchers

Nicotinamide Mononucleotide
NAD+ Metabolism
Exercise Tolerance
Aging
Older Adults
Betaine
Hydrogen Peroxide (low-dose, dietary)
High Intensity Interval Training
VO2peak
Lactate Threshold
Critical Power
Anaerobic Work Capacity
Healthy Volunteers

Additional Relevant MeSH Terms

Aging
Frailty
Exercise Tolerance
Healthy Male and Female Subjects