Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07144527

Nicotinamide Mononucleotide Supplementation for Exercise Tolerance Improvement in Healthy Older Adults

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Scott Silveira · Academic / Other
Sex
All
Age
60 Years – 80 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

This randomized, double-blind, placebo-controlled, two-arm crossover trial will compare the effects of two NAD⁺-modulating interventions-EGA® and conventional nicotinamide mononucleotide (NMN) supplementation-on exercise tolerance and metabolic biomarkers in healthy older adults. EGA® is a proprietary formulation composed of three endogenously occurring metabolomic compounds (including NMN) and has been used in prior non-FDA-regulated studies involving human participants. The EGA® arm will involve a twice-daily oral dose of EGA® containing 1000 mg of NMN, while the comparison arm will involve twice-daily oral dose of 1000 mg of conventional NMN per day. Doses will be self-administered each morning and evening with water. 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

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTNMN, betaine, low-dose hydrogen peroxide (EGA)Proprietary formulation containing NMN, betaine, and low-dose hydrogen peroxide.
DIETARY_SUPPLEMENTNicotinamide Mononucleotide (NMN)Conventional NMN supplement.
DIETARY_SUPPLEMENTPlaceboOrganoleptically matched inert control.

Timeline

Start date
2026-02-21
Primary completion
2026-12-30
Completion
2027-01-01
First posted
2025-08-27
Last updated
2026-02-20

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07144527. Inclusion in this directory is not an endorsement.