Healthspan Improvement, Aging, Longevity
Conditions
Keywords
Gerotherapeutics, Rapamycin, Naltrexone, Metformin, NAD+, GSH, B12
Brief summary
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).
Detailed description
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.
Interventions
DRUGRapamycin
In the comprehensive therapy group, participants will start LDR at 2mg once per week and titrate up weekly to 6mg once per week.
DRUGNaltrexone
In both intervention groups, participants will start LDN at 1.5mg once daily and titrate up each week to 4.5mg daily.
DRUGMetformin
In both intervention groups, participants will take Metformin at 500mg daily.
DRUGNAD+
In both intervention groups, NAD+ will be taken as a nasal spray of 30mg/day.
DRUGGSH
In the comprehensive therapy group, GSH will be taken as a topical patch for 4 hrs, once per week.
DIETARY_SUPPLEMENTInfinite Supplement
Participants in the comprehensive therapy group will take the Infinite supplement once daily. The Infinite supplement is a proprietary blend of seven putative geroprotective compounds implicated in enhancing cellular function critical for managing cellular damage accumulation prevention of age-related decline (including Alpha ketoglutarate, Quercetin, Glucosamine, Carnosine, Pterostilbene, Astaxanthin, and Curcumin)
DRUGPlacebo/control
In the control cohort, participants will take Vitamin C (1x/day) and Vitamin E (1x/week) as placebo agents.
DIETARY_SUPPLEMENTB12
In both intervention groups, participants will take vitamin B12 once daily.
BEHAVIORALIntervention: Guided Meditation Program
Intervention group participants will follow a daily, app-based meditation program for 20 minutes a day.
BEHAVIORALControl: Podcast Listening Activity
Control participants will listen to a neutral podcast for 20 minutes a day designed to control for time and attention.
BEHAVIORALControl: Standard Exercise Regimen
Control group participants will engage in a standard exercise regimen (150 minutes of aerobic activity such as walking per week).
BEHAVIORALIntervention: Structured Exercise Program
Intervention group participants will follow a structured daily exercise program including resistance training and a recommendation for 150 minutes of aerobic activity (e.g., walking) per week.
Sponsors
AgelessRx
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* New, existing, or prospective AgelessRx patient * Adults (60-80 years of age) * Any sex * 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in cardiorespiratory fitness measured by maximal oxygen uptake (VO₂ max) | 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 | 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 | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in total sleep time measured using Oura wearable device | 3 months | Total sleep time will be assessed using sleep data collected from the Oura Ring wearable device. Total sleep time represents the total duration of sleep obtained during the primary sleep period each night. Total sleep time will be measured twice at baseline and twice during the final study period, with measurements occurring at least 7 days apart. Values from each assessment period will be averaged to determine the baseline and 3-month outcome values. The outcome will be the change in average nightly total sleep time from baseline to 3 months. |
| Change in health-related quality of life measured by the Short Form Health Survey (SF-36) | 3 months | Quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). Scores range from 0 to 100, with higher scores indicating better health-related quality of life. Assessments will be conducted twice at baseline and twice at the 3-month follow-up, with measurements occurring at least 7 days apart. Values from the two assessments at each timepoint will be averaged. The outcome will be the change in overall SF-36 score from baseline to 3 months. |
| Change in biological age estimated from blood-based biomarker panels | 3 months | Biological age will be estimated using biomarker panels derived from the iollo home testing kit. his assessment will be conducted once at baseline and once at the 3-month follow-up. The outcome will be the change in estimated biological age from baseline to 3 months. |
| Change in sleep quality measured by the Sleep Quality Scale (SQS) | 3 months | Sleep quality will be assessed using the Sleep Quality Scale (SQS), a validated self-report instrument ranging from 0 to 84, where higher scores indicate worse sleep quality. Assessments will be conducted twice at baseline and twice at the 3-month follow-up, with measurements occurring at least 7 days apart. Values from the two assessments at each timepoint will be averaged. The outcome will be the change in overall sleep score from baseline to 3 months. |
| Change in physical activity measured by the Rapid Assessment of Physical Activity (RAPA) questionnaire | 3 months | Physical activity will be assessed using the Rapid Assessment of Physical Activity (RAPA) questionnaire. Scores range from 1 to 7, with higher scores indicating greater levels of physical activity. Assessments will be conducted twice at baseline and twice at the 3-month follow-up, with measurements occurring at least 7 days apart. Values from the two assessments at each timepoint will be averaged. The outcome will be the change in physical activity score from baseline to 3 months. |
| Change in self-reported immune function measured by the Immune Status Questionnaire (ISQ) | 3 months | Self-reported immune function will be assessed using the Immune Status Questionnaire (ISQ), a validated self-report instrument that evaluates the frequency of immune-related symptoms (e.g., colds, fever, cough, and other infection-related complaints). The ISQ produces a total score ranging from 0 to 10, with higher scores indicating better perceived immune functioning. Assessments will be conducted twice at baseline and twice at the 3-month follow-up, with measurements occurring at least 7 days apart. Values from the two assessments at each timepoint will be averaged. The outcome will be the change in ISQ total score from baseline to 3 months. |
| Change from baseline to 3 months in hemoglobin A1c | 3 months | Hemoglobin A1c (HbA1c) will be measured from venous blood samples collected during routine laboratory testing. HbA1c reflects average blood glucose levels over approximately the prior 2-3 months. Blood samples will be collected twice at baseline and twice during the final study period with assessments occurring at least 7 days apart. Values from each timepoint will be averaged. |
| Change from baseline to 3 months in fasting insulin concentration | 3 months | Fasting insulin will be measured from venous blood samples collected during routine laboratory testing. Blood samples will be collected twice at baseline and twice during the final study period with assessments occurring at least 7 days apart. Measurements from each timepoint will be averaged. |
| Change from baseline to 3 months in high-sensitivity C-reactive protein (hs-CRP) | 3 months | High-sensitivity C-reactive protein (hs-CRP) will be measured from venous blood samples as a marker of systemic inflammation. Blood samples will be collected twice at baseline and twice during the final study period with assessments occurring at least 7 days apart. Measurements from each timepoint will be averaged. |
| Change from baseline to 3 months in low-density lipoprotein cholesterol (LDL-C) | 3 months | Low-density lipoprotein cholesterol will be measured from fasting venous blood samples as part of a lipid panel. Blood samples will be collected twice at baseline and twice during the final study period with assessments occurring at least 7 days apart. Measurements from each timepoint will be averaged. |
| Change from baseline to 3 months in high-density lipoprotein cholesterol (HDL-C) | 3 months | High-density lipoprotein cholesterol will be measured from fasting venous blood samples as part of a lipid panel. Blood samples will be collected twice at baseline and twice during the final study period with assessments occurring at least 7 days apart. Measurements from each timepoint will be averaged. |
| Change from baseline to 3 months in fasting triglyceride levels | 3 months | Triglycerides will be measured from fasting venous blood samples as part of a lipid panel. Blood samples will be collected twice at baseline and twice during the final study period with assessments occurring at least 7 days apart. Measurements from each timepoint will be averaged. |
| Change from baseline to 3 months in fasting plasma glucose | 3 months | Fasting glucose will be measured from venous blood samples collected during routine laboratory testing. Blood samples will be collected twice at baseline and twice during the final study period with assessments occurring at least 7 days apart. Measurements from each timepoint will be averaged. |
| Change from baseline to 3 months in creatinine | 3 months | Creatinine will be measured from venous blood samples as part of a comprehensive metabolic panel to assess kidney function. Blood samples will be collected twice at baseline and twice during the final study period with assessments occurring at least 7 days apart. Measurements from each timepoint will be averaged. |
| Change from baseline to 3 months in white blood cell count | 3 months | White blood cell (WBC) count will be measured from venous blood samples as part of a complete blood count panel. Blood samples will be collected twice at baseline and twice during the final study period with assessments occurring at least 7 days apart. Measurements from each timepoint will be averaged. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJenell Decker, MD
AgelessRx
PRINCIPAL_INVESTIGATORStefanie Morgan, PhD
AgelessRx
Outcome results
None listed