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治験 NCT07144527（対象：老化、虚弱、運動耐性、Healthy Male and Female Subjects）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
Nicotinamide Mononucleotide Supplementation for Exercise Tolerance Improvement in Healthy Older Adults
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます！「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07144527 は 介入研究 臨床試験 で、老化、虚弱、運動耐性、Healthy Male and Female Subjects に関するものです。現在は 募集中 で、2025年9月15日 から開始しています。40 名の参加者 の募集が計画されています。この治験は Scott Silveira によって主催され、2026年11月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年9月16日 です。
概要
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.
詳細説明
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.
公式タイトル
Nicotinamide Mononucleotide Supplementation for Exercise Tolerance Improvement in Healthy Older Adults
疾患／病気
老化虚弱運動耐性Healthy Male and Female Subjectsその他の研究識別子
- 2305604-1
NCT番号
開始日
2025-09-15
最終更新日
2025-09-16
終了予定日
2026-11-01
目標参加者数
40
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集中
キーワード
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
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
主目的
基礎研究
割付方法
無作為化
介入モデル
交叉・クロスオーバー
盲検化
四重盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的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. プラセボ Organoleptically matched inert control. |
実験的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. プラセボ Organoleptically matched inert control. |
実験的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. プラセボ Organoleptically matched inert control. |
実験的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. プラセボ Organoleptically matched inert control. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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. |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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. |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
60 Years
対象性別
全て
健康なボランティアを受け入れる
はい
- 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- Concordia University Chicago
- EGACeutical
責任者
Scott Silveira, 治験依頼者・主任研究者, Principle Investigator, Concordia University Chicago
連絡先情報がありません。
1 1カ国の場所
California
Medical Office of Dr. Robert Huizenga MD, Beverly Hills, California, 90210, United States
Nancy Castellanos, BA, 連絡先, 310-666-6585, [email protected]
Ashley Erazo, Medical Assistant, 連絡先, 310-657-9191, [email protected]
Scott R Silveira, Ph.D. (c), 研究責任者
募集中