A Pilot Randomized Controlled Study of Combinatorial Gerotherapeutics for Healthspan Improvement
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in cardiorespiratory fitness measured by maximal oxygen uptake (VO₂ max)
研究概览
简要总结
This study is a 90-day interventional, randomized, controlled pilot trial exploring multi-modal gerotherapies and their impact on longevity-related outcomes. In this proof-of-concept phase, a small sample size of up to 30 subjects (10 subjects in each arm) will be randomized into one of the three arms: 1) Control, 2) Multi-therapy (B12, Naltrexone, Metformin, and NAD+), or 4) Comprehensive Therapy (Rapamycin, Naltrexone, Metformin, B12, NAD+, GSH, and Infinite Supplement).
详细描述
The two main study objectives are 1) To evaluate the impact of different combinations of gerotherapeutics on measures of muscle, cognitive, and immune function, & 2) To assess the impact of the combinatorial gerotherapeutics on sleep measures, perceived quality of life, and longevity biomarkers. Potential subjects will be recruited utilizing email and social media-based methods. They will be screened for eligibility and enrolled in the study upon obtaining informed consent. All groups will complete DEXA scans, V02 Max tests, Creyos cognitive assessments, Edifice Health's iAge tests, iollo at-home blood testing kits, routine blood-work, and the following standardized survey questionnaires: ISQ (Immune Status Questionnaire), SF-36 (Quality of Life), RAPA (Rapid Assessment of Physical Activity), and SQS (Sleep Quality Survey). Subjects will set up Oura data-tracking for health biometric data with study staff assistance. Intervention group participants will also receive a guided meditation program and structured exercise program to follow throughout the study. In contrast, participants in the control group will engage in a standard exercise regimen (150 minutes per week) and listen to a neutral podcast designed to control for time and attention.
Participants will be evaluated at baseline and study end for measures of muscle function (by DEXA scan of muscle mass and the VO2 max test to measure endurance capacity using a formal test and/or Oura ring estimate), cognitive function (by Creyos cognitive tests via web browser), immune function (by iAge and CD4+ : CD8+ ratio/lymphocyte : neutrophil ratio with Immune Status Questionnaire (ISQ) supplementation), SF-36 Quality of Life (SF-36 QoL) survey scores, PhenoAge (from blood biomarkers obtained from routine safety labs, detailed below), activity levels (RAPA questionnaire, Oura ring), metabolic health measures from routine and at-home blood tests, sleep improvements evaluated through Oura wearable device sleep quality and quantity as well as the Sleep Quality Survey (SQS), as well as other health indicators from Oura wearable data between baseline and study end. To ensure robustness of outcome measures, two measurements of each item 1 week apart will be used at baseline and again at study end for all measures except for DEXA scan, V02 max formal test and Oura ring estimate, iAge and iollo kits, which will be used once at the beginning and once at the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •New, existing, or prospective AgelessRx patient
- •Adults (60-80 years of age)
- •Any ethnicity
- •Willingness to provide informed consent and complete study assessments/procedures
- •Willingness to attend virtual meeting check-ins/follow-ups
- •Willingness and eligibility to take all medications used in this study
- •Has at-risk indicators for decline on measures of cognitive, immune, and muscle function, as indicated by a combination of BMI of 26-30; SF36 score below the validated central tendency for 2 of: physical function, physical role limitations, energy, pain; final ISQ scores of <6; individuals that report brain fog or difficulty with mental clarity; pre-diabetic, or other comorbidities that result in reduced overall health functioning as determined by a physician
排除标准
- •Pregnant or breastfeeding individuals
- •History of severe adverse reactions to study medications
- •Significant psychiatric illness that may affect participation
- •Determination of ineligibility for a study medication by AgelessRx medical team
- •Concurrent participation in other conflicting clinical trials
研究组 & 干预措施
Multi-Therapy: NAD+, LDN, B12, and metformin
In intervention month one, participants naive to all medications will be titrated on to low maintenance doses of each. NAD+ will be taken as a nasal spray of 30mg/day; LDN, will start at 1.5mg once daily and titrate up each week to 4.5mg daily; B12, take 1 cap per day (100mcg); Metformin will be taken 500mg daily. They will then remain on the maintenance doses of the combination therapy for the next 60 days.
干预措施: Naltrexone (Drug)
Multi-Therapy: NAD+, LDN, B12, and metformin
In intervention month one, participants naive to all medications will be titrated on to low maintenance doses of each. NAD+ will be taken as a nasal spray of 30mg/day; LDN, will start at 1.5mg once daily and titrate up each week to 4.5mg daily; B12, take 1 cap per day (100mcg); Metformin will be taken 500mg daily. They will then remain on the maintenance doses of the combination therapy for the next 60 days.
干预措施: Metformin (Drug)
Multi-Therapy: NAD+, LDN, B12, and metformin
In intervention month one, participants naive to all medications will be titrated on to low maintenance doses of each. NAD+ will be taken as a nasal spray of 30mg/day; LDN, will start at 1.5mg once daily and titrate up each week to 4.5mg daily; B12, take 1 cap per day (100mcg); Metformin will be taken 500mg daily. They will then remain on the maintenance doses of the combination therapy for the next 60 days.
干预措施: NAD+ (Drug)
Multi-Therapy: NAD+, LDN, B12, and metformin
In intervention month one, participants naive to all medications will be titrated on to low maintenance doses of each. NAD+ will be taken as a nasal spray of 30mg/day; LDN, will start at 1.5mg once daily and titrate up each week to 4.5mg daily; B12, take 1 cap per day (100mcg); Metformin will be taken 500mg daily. They will then remain on the maintenance doses of the combination therapy for the next 60 days.
干预措施: B12 (Dietary Supplement)
Multi-Therapy: NAD+, LDN, B12, and metformin
In intervention month one, participants naive to all medications will be titrated on to low maintenance doses of each. NAD+ will be taken as a nasal spray of 30mg/day; LDN, will start at 1.5mg once daily and titrate up each week to 4.5mg daily; B12, take 1 cap per day (100mcg); Metformin will be taken 500mg daily. They will then remain on the maintenance doses of the combination therapy for the next 60 days.
干预措施: Intervention: Guided Meditation Program (Behavioral)
Multi-Therapy: NAD+, LDN, B12, and metformin
In intervention month one, participants naive to all medications will be titrated on to low maintenance doses of each. NAD+ will be taken as a nasal spray of 30mg/day; LDN, will start at 1.5mg once daily and titrate up each week to 4.5mg daily; B12, take 1 cap per day (100mcg); Metformin will be taken 500mg daily. They will then remain on the maintenance doses of the combination therapy for the next 60 days.
干预措施: Intervention: Structured Exercise Program (Behavioral)
Comprehensive Therapy: LDR, LDN, B12, metformin, NAD+, GSH, and Infinite
In intervention month one, participants naive to all medications will be titrated on to low maintenance doses of each. LDR will start at 2mg once per week and titrate up weekly to 6mg once per week; LDN, will start at 1.5mg once daily and titrate up each week to 4.5mg daily; B12, take 1 cap per day (100mcg); Metformin will be taken 500mg daily; NAD+ will be taken as a nasal spray of 30mg/day; GSH will be taken as a topical patch for 4 hrs, once per week; Infinite supplement will be taken once daily. They will then remain on the maintenance doses of the combination therapy for the next 60 days.
干预措施: Rapamycin (Drug)
Comprehensive Therapy: LDR, LDN, B12, metformin, NAD+, GSH, and Infinite
In intervention month one, participants naive to all medications will be titrated on to low maintenance doses of each. LDR will start at 2mg once per week and titrate up weekly to 6mg once per week; LDN, will start at 1.5mg once daily and titrate up each week to 4.5mg daily; B12, take 1 cap per day (100mcg); Metformin will be taken 500mg daily; NAD+ will be taken as a nasal spray of 30mg/day; GSH will be taken as a topical patch for 4 hrs, once per week; Infinite supplement will be taken once daily. They will then remain on the maintenance doses of the combination therapy for the next 60 days.
干预措施: Naltrexone (Drug)
Comprehensive Therapy: LDR, LDN, B12, metformin, NAD+, GSH, and Infinite
In intervention month one, participants naive to all medications will be titrated on to low maintenance doses of each. LDR will start at 2mg once per week and titrate up weekly to 6mg once per week; LDN, will start at 1.5mg once daily and titrate up each week to 4.5mg daily; B12, take 1 cap per day (100mcg); Metformin will be taken 500mg daily; NAD+ will be taken as a nasal spray of 30mg/day; GSH will be taken as a topical patch for 4 hrs, once per week; Infinite supplement will be taken once daily. They will then remain on the maintenance doses of the combination therapy for the next 60 days.
干预措施: Metformin (Drug)
Comprehensive Therapy: LDR, LDN, B12, metformin, NAD+, GSH, and Infinite
In intervention month one, participants naive to all medications will be titrated on to low maintenance doses of each. LDR will start at 2mg once per week and titrate up weekly to 6mg once per week; LDN, will start at 1.5mg once daily and titrate up each week to 4.5mg daily; B12, take 1 cap per day (100mcg); Metformin will be taken 500mg daily; NAD+ will be taken as a nasal spray of 30mg/day; GSH will be taken as a topical patch for 4 hrs, once per week; Infinite supplement will be taken once daily. They will then remain on the maintenance doses of the combination therapy for the next 60 days.
干预措施: NAD+ (Drug)
Comprehensive Therapy: LDR, LDN, B12, metformin, NAD+, GSH, and Infinite
In intervention month one, participants naive to all medications will be titrated on to low maintenance doses of each. LDR will start at 2mg once per week and titrate up weekly to 6mg once per week; LDN, will start at 1.5mg once daily and titrate up each week to 4.5mg daily; B12, take 1 cap per day (100mcg); Metformin will be taken 500mg daily; NAD+ will be taken as a nasal spray of 30mg/day; GSH will be taken as a topical patch for 4 hrs, once per week; Infinite supplement will be taken once daily. They will then remain on the maintenance doses of the combination therapy for the next 60 days.
干预措施: GSH (Drug)
Comprehensive Therapy: LDR, LDN, B12, metformin, NAD+, GSH, and Infinite
In intervention month one, participants naive to all medications will be titrated on to low maintenance doses of each. LDR will start at 2mg once per week and titrate up weekly to 6mg once per week; LDN, will start at 1.5mg once daily and titrate up each week to 4.5mg daily; B12, take 1 cap per day (100mcg); Metformin will be taken 500mg daily; NAD+ will be taken as a nasal spray of 30mg/day; GSH will be taken as a topical patch for 4 hrs, once per week; Infinite supplement will be taken once daily. They will then remain on the maintenance doses of the combination therapy for the next 60 days.
干预措施: Infinite Supplement (Dietary Supplement)
Comprehensive Therapy: LDR, LDN, B12, metformin, NAD+, GSH, and Infinite
In intervention month one, participants naive to all medications will be titrated on to low maintenance doses of each. LDR will start at 2mg once per week and titrate up weekly to 6mg once per week; LDN, will start at 1.5mg once daily and titrate up each week to 4.5mg daily; B12, take 1 cap per day (100mcg); Metformin will be taken 500mg daily; NAD+ will be taken as a nasal spray of 30mg/day; GSH will be taken as a topical patch for 4 hrs, once per week; Infinite supplement will be taken once daily. They will then remain on the maintenance doses of the combination therapy for the next 60 days.
干预措施: B12 (Dietary Supplement)
Comprehensive Therapy: LDR, LDN, B12, metformin, NAD+, GSH, and Infinite
In intervention month one, participants naive to all medications will be titrated on to low maintenance doses of each. LDR will start at 2mg once per week and titrate up weekly to 6mg once per week; LDN, will start at 1.5mg once daily and titrate up each week to 4.5mg daily; B12, take 1 cap per day (100mcg); Metformin will be taken 500mg daily; NAD+ will be taken as a nasal spray of 30mg/day; GSH will be taken as a topical patch for 4 hrs, once per week; Infinite supplement will be taken once daily. They will then remain on the maintenance doses of the combination therapy for the next 60 days.
干预措施: Intervention: Guided Meditation Program (Behavioral)
Comprehensive Therapy: LDR, LDN, B12, metformin, NAD+, GSH, and Infinite
In intervention month one, participants naive to all medications will be titrated on to low maintenance doses of each. LDR will start at 2mg once per week and titrate up weekly to 6mg once per week; LDN, will start at 1.5mg once daily and titrate up each week to 4.5mg daily; B12, take 1 cap per day (100mcg); Metformin will be taken 500mg daily; NAD+ will be taken as a nasal spray of 30mg/day; GSH will be taken as a topical patch for 4 hrs, once per week; Infinite supplement will be taken once daily. They will then remain on the maintenance doses of the combination therapy for the next 60 days.
干预措施: Intervention: Structured Exercise Program (Behavioral)
Placebo
In the control cohort, participants will take Vitamin C (1x/day) and Vitamin E (1x/week) as placebo agents.
干预措施: Placebo/control (Drug)
Placebo
In the control cohort, participants will take Vitamin C (1x/day) and Vitamin E (1x/week) as placebo agents.
干预措施: Control: Podcast Listening Activity (Behavioral)
Placebo
In the control cohort, participants will take Vitamin C (1x/day) and Vitamin E (1x/week) as placebo agents.
干预措施: Control: Standard Exercise Regimen (Behavioral)
结局指标
主要结局
Change in cardiorespiratory fitness measured by maximal oxygen uptake (VO₂ max)
时间窗: 3 months
Maximal oxygen uptake (VO₂ max) will be assessed using standardized cardiopulmonary exercise testing. This assessment will be conducted once at baseline and once at the 3-month follow-up. The outcome will be the change in VO₂ max from baseline to 3 months.
Change in cognitive performance measured by Creyos Cognitive Test composite score
时间窗: 3 months
Cognitive performance will be assessed using the Creyos online cognitive assessment platform. Assessments will be conducted twice at baseline and twice during the final study period, with measurements occurring at least 7 days apart. Scores from the two assessments at each timepoint will be averaged to determine the baseline and endpoint values. The outcome will be the change in the overall composite cognitive performance score from baseline to 3 months.
Change in systemic chronic inflammation measured by iAge index score
时间窗: 3 months
Immune function will be assessed via systemic chronic inflammation using the iAge Index Score derived from blood biomarkers. This assessment will be conducted once at baseline and once at the 3-month follow-up. The outcome will be the change in iAge index score from baseline to 3 months.
Change in lean body mass measured by dual-energy X-ray absorptiometry (DEXA)
时间窗: 3 months
Lean body mass will be assessed using dual-energy X-ray absorptiometry (DEXA). This assessment will be conducted once at baseline and once at the 3-month follow-up. The outcome will be the change in total lean body mass from baseline to 3 months.
次要结局
- Change from baseline to 3 months in white blood cell count(3 months)
- Change in total sleep time measured using Oura wearable device(3 months)
- Change in health-related quality of life measured by the Short Form Health Survey (SF-36)(3 months)
- Change in biological age estimated from blood-based biomarker panels(3 months)
- Change in sleep quality measured by the Sleep Quality Scale (SQS)(3 months)
- Change in physical activity measured by the Rapid Assessment of Physical Activity (RAPA) questionnaire(3 months)
- Change in self-reported immune function measured by the Immune Status Questionnaire (ISQ)(3 months)
- Change from baseline to 3 months in hemoglobin A1c(3 months)
- Change from baseline to 3 months in fasting insulin concentration(3 months)
- Change from baseline to 3 months in high-sensitivity C-reactive protein (hs-CRP)(3 months)
- Change from baseline to 3 months in low-density lipoprotein cholesterol (LDL-C)(3 months)
- Change from baseline to 3 months in high-density lipoprotein cholesterol (HDL-C)(3 months)
- Change from baseline to 3 months in fasting triglyceride levels(3 months)
- Change from baseline to 3 months in fasting plasma glucose(3 months)
- Change from baseline to 3 months in creatinine(3 months)