Nicotinamide Mononucleotide Supplementation for Exercise Tolerance Improvement in Healthy Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Time to Fatigue During Constant Work Rate Cycle Ergometry (tLIM).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm 1 - EGA -> Placebo
Participants receive EGA during Period 1, followed by Placebo during Period 2 after a washout. Assigned Interventions: EGA; Placebo.
干预措施: NMN, betaine, low-dose hydrogen peroxide (EGA) (Dietary Supplement)
Arm 1 - EGA -> Placebo
Participants receive EGA during Period 1, followed by Placebo during Period 2 after a washout. Assigned Interventions: EGA; Placebo.
干预措施: Placebo (Dietary Supplement)
Arm 2 - Placebo -> EGA
Participants receive Placebo during Period 1, followed by EGA during Period 2 after a washout. Assigned Interventions: Placebo; EGA.
干预措施: NMN, betaine, low-dose hydrogen peroxide (EGA) (Dietary Supplement)
Arm 2 - Placebo -> EGA
Participants receive Placebo during Period 1, followed by EGA during Period 2 after a washout. Assigned Interventions: Placebo; EGA.
干预措施: Placebo (Dietary Supplement)
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.
干预措施: Placebo (Dietary Supplement)
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.
干预措施: Nicotinamide Mononucleotide (NMN) (Dietary Supplement)
Arm 4 - Placebo -> NMN
Participants receive Placebo during Period 1, followed by NMN during Period 2 after a washout. Assigned Interventions: Placebo; NMN.
干预措施: Nicotinamide Mononucleotide (NMN) (Dietary Supplement)
Arm 4 - Placebo -> NMN
Participants receive Placebo during Period 1, followed by NMN during Period 2 after a washout. Assigned Interventions: Placebo; NMN.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Time to Fatigue During Constant Work Rate Cycle Ergometry (tLIM).
时间窗: Measured at the beginning and end of each 4-week intervention period.
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.
次要结局
- Lactate Threshold(Measured at the beginning and end of each 4-week intervention period.)
- Circulating NAD+ and Related Metabolites(Measured at the beginning and end of each 4-week intervention period.)
- Peak Oxygen Uptake (VO2max)(Measured at the beginning and end of each 4-week intervention period.)
- Anaerobic Work Capacity(Measured at the beginning and end of each 4-week intervention period.)
- Critical Power(Measured at the beginning and end of each 4-week intervention period.)
研究者
Scott Silveira
Principle Investigator
Concordia University Chicago