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רדאר קליני AI
הניסוי הקליני NCT07144527 עבור הזדקנות, שבריריות, סבילות לפעילות גופנית, Healthy Male and Female Subjects הוא מגייס. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן.
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תצוגת כרטיסים
חזרה לחיפוש

Nicotinamide Mononucleotide Supplementation for Exercise Tolerance Improvement in Healthy Older Adults

מגייס
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'קבל הסבר' כדי לצפות ולשוחח על מידע מהניסוי בשפה המועדפת עליך.
הניסוי הקליני NCT07144527 הוא מחקר מסוג מתערב עבור הזדקנות, שבריריות, סבילות לפעילות גופנית, Healthy Male and Female Subjects, שנמצא כעת במצב מגייס. המחקר התחיל ב-15 בספטמבר 2025 ומתוכנן לכלול 40 משתתפים. המחקר מנוהל על ידי Scott Silveira וצפוי להסתיים ב-1 בנובמבר 2026. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-16 בספטמבר 2025.
סיכום קצר
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.

תיאור מפורט
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.

כותרת רשמית

Nicotinamide Mononucleotide Supplementation for Exercise Tolerance Improvement in Healthy Older Adults

מצבים רפואיים
הזדקנותשבריריותסבילות לפעילות גופניתHealthy Male and Female Subjects
מזהי מחקר נוספים
  • 2305604-1
מספר NCT
NCT07144527
תחילת המחקר (בפועל)
2025-09-15
עדכון אחרון שפורסם
2025-09-16
סיום המחקר (מוערך)
2026-11-01
השתתפות (מוערכת)
40
סוג המחקר
מתערב
שלב
לא זמין
סטטוס
מגייס
מילות מפתח
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
מטרה ראשית
מדע בסיסי
הקצאת טיפול
מחקר אקראי
דגם מתערב
שיוך צלב
עיוורון
ארבעה
זרועות / התערבויות
קבוצת משתתפים/זרועהתערבות/טיפול
ניסיArm 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.
פלצבו
Organoleptically matched inert control.
ניסיArm 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.
פלצבו
Organoleptically matched inert control.
ניסיArm 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.
פלצבו
Organoleptically matched inert control.
ניסיArm 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.
פלצבו
Organoleptically matched inert control.
תוצאה ראשית
מדד תוצאהתיאור המדידהטווח זמן
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.
Measured at the beginning and end of each 4-week intervention period.
תוצאה משנית
מדד תוצאהתיאור המדידהטווח זמן
Peak Oxygen Uptake (VO2max)
Maximum oxygen consumption (ml/kg/min) achieved during graded exercise testing.
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.
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.
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.
Measured at the beginning and end of each 4-week intervention period.
Circulating NAD+ and Related Metabolites
Plasma concentrations of NAD+, NMN, and related metabolites measured by targeted metabolomics.
Measured at the beginning and end of each 4-week intervention period.
קריטריוני זכאות

גילאים מוערכים למחקר
מבוגר, מבוגר יותר
גיל מינימלי למחקר
60 Years
מגדרים מוערכים למחקר
הכל
מתנדבים בריאים מתקבלים
כן
  • 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
Scott Silveira logoScott Silveira
  • Concordia University Chicago logoConcordia University Chicago
  • EGACeutical logoEGACeutical
המשתתף האחראי למחקר
Scott Silveira, חוקר נותן החסות, Principle Investigator, Concordia University Chicago
אין נתוני קשר.
1 מיקומי המחקר ב-1 מדינות

California

Medical Office of Dr. Robert Huizenga MD, Beverly Hills, California, 90210, United States
Nancy Castellanos, BA, צור קשר, 310-666-6585, [email protected]
Ashley Erazo, Medical Assistant, צור קשר, 310-657-9191, [email protected]
Scott R Silveira, Ph.D. (c), חוקר ראשי
מגייס