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100-Year Human Aging Study

2 września 2026 zaktualizowane przez: William Brandenburg, MD, Longevity Metrics, Inc.

100-Year Human Aging Study: Prospective Longitudinal Validation of Multi-System Health Measurements Against Mortality and Aging Outcomes

The 100-Year Human Aging Study is a prospective, pragmatic, observational trial enrolling participants across fixed clinical sites, mobile clinical sites, and an online participation pathway (current and future) to undergo comprehensive multi-system health screening and longitudinal follow-up until death. Participants are followed to determine whether measurements taken at enrollment and repeated across the lifespan - individually and in combination - predict all-cause mortality, cause-specific mortality, incident serious disease, and functional disability. The study is designed to generate the surrogate endpoint validation data that longevity medicine currently lacks.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

All currently existing longevity measures are surrogate endpoints that have not been prospectively validated against actual mortality and aging outcomes. The 100-Year Human Aging Study is a prospective, pragmatic, observational trial that addresses this gap by enrolling participants in comprehensive clinical screening and following them longitudinally until death to determine which measurements - alone and in combination - are predictive of mortality, serious disease, and functional disability.

The study prioritizes dynamic measurements: the physiological, cognitive, social, and environmental capacities that change with aging and are most likely to carry predictive signal for mortality and functional outcomes. These include cardiorespiratory fitness (cardiopulmonary exercise testing with ventilatory threshold analysis), strength (grip, explosive power, functional movement), mobility and balance, neurocognitive performance, sensory function (vision, hearing, smell, light touch), and metabolic function (oral glucose tolerance, continuous glucose monitoring), in addition to other testing. Structural and imaging assessments include body composition and bone mineral density by DEXA, echocardiography, resting and stress electrocardiography, spirometry, retinal fundus photography, and vascular ultrasound. Laboratory measures are drawn on-site and processed through a CLIA-certified reference laboratory. Complete medical, surgical, family, social, occupational, and environmental histories are obtained at each visit.

Participation ranges from single-service visits - including standalone DEXA, cardiopulmonary exercise testing, laboratory panel testing, and sleep studies - to the full two-visit comprehensive screening battery. All participation pathways contribute clinical data to the longitudinal mortality and aging outcomes linkage framework regardless of service level. Participants are encouraged to return for repeat testing to build longitudinal health trajectories across the lifespan.

At enrollment and across longitudinal follow-up, the study platform generates individualized investigational constructs including biological age estimate, predicted death age, and predicted cause of death profile. These are explicitly investigational hypotheses, not validated clinical standards. Their predictive validity relative to actual mortality, aging outcomes, and functional disability is a central scientific question this study is designed to answer, both for individual measures and for composite multi-system models.

All data are archived in their highest-dimensional raw form to preserve the ability to apply future analytical methods retroactively. Participants are followed with periodic contact and offered repeat screening throughout the lifespan. Longitudinal outcomes ascertainment includes all-cause mortality, cause-specific mortality, incident serious health events, chronic disease diagnosis, functional independence, disability status, and health behavior change.

Study sites and participation pathways. The 100-Year Human Aging Study is conducted across all Longevity Metrics participation pathways, current and future: the Boulder Human Performance Lab (fixed flagship laboratory); mobile screening units including the Health Ahead Bus; any additional fixed or mobile Longevity Metrics laboratory established during the study period; and an online participation pathway through which participants enroll and contribute structured data without in-person screening. All pathways operate under a single protocol with identical procedures, data management, informed consent, and safety standards.

This study is one of four that compound into one system. The Human Observatory Study (NCT07646782) validates sociodemographic and environmental data against the same outcomes, and receives each model's geographic residuals. The Health Ahead Comparative Effectiveness Study (NCT07669168) moves the screening toward increasing automation and mobility while maintaining quality. The Longevity Metrics AI/ML Development Study (NCT pending approval) builds the models that make automation, prediction, and broad utilization possible. This study supplies the clinical data and validates what it means for health, disease, disability, and death.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

1000000

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

Participants of all ages, health statuses, and demographic backgrounds presenting for comprehensive preventive health screening at fixed or mobile clinical sites. No exclusions based on health status, geographic location, language, or population group. Participants with limited decision-making capacity may be enrolled with consent from a legally authorized representative. The study actively seeks to enroll participants across the full human lifespan including older adults and centenarians.

Opis

Inclusion Criteria:

  • Age 18 years or older
  • Willing and able to provide written informed consent, or enrollment with consent of a legally authorized representative
  • Willing to participate in longitudinal follow-up

Exclusion Criteria:

  • Age under 18 years

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
All-Cause Mortality
Ramy czasowe: From enrollment until death, assessed periodically, up to 100 years
Vital status ascertained through longitudinal follow-up contact, mortality record linkage, and health data network linkage using probabilistic matching on name, date of birth, and address history.
From enrollment until death, assessed periodically, up to 100 years
Cause-Specific Mortality
Ramy czasowe: From enrollment until death, assessed periodically, up to 100 years
Cause of death ascertained via death certificate and mortality record linkage.
From enrollment until death, assessed periodically, up to 100 years

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Cause-Specific Mortality Prediction Accuracy
Ramy czasowe: From enrollment until death, assessed periodically, up to 100 years
Concordance between predicted cause of death profile generated at enrollment and actual cause of death ascertained at follow-up.
From enrollment until death, assessed periodically, up to 100 years
Incident Serious Adverse Health Events
Ramy czasowe: Periodically from enrollment until death, up to 100 years
New diagnosis of myocardial infarction, stroke, cancer, dementia, heart failure, atrial fibrillation, sepsis, venous thromboembolism, COPD, chronic hypoxia, or major fracture ascertained via periodic follow-up contact and health data network linkage.
Periodically from enrollment until death, up to 100 years
Incident Chronic Disease
Ramy czasowe: Periodically from enrollment until death, up to 100 years
New diagnosis of type 2 diabetes, hypertension, COPD, chronic kidney disease, metabolic syndrome, or osteoporosis ascertained via self-report and health data network linkage.
Periodically from enrollment until death, up to 100 years
Functional Independence and Disability Status
Ramy czasowe: Periodically from enrollment until death, up to 100 years
Activities of daily living, instrumental activities of daily living, and self-reported disability status ascertained via periodic health survey using validated open-source instruments. Higher composite scores indicate greater functional independence. Specific instruments will be selected prior to first follow-up contact and documented in the statistical analysis plan.
Periodically from enrollment until death, up to 100 years
Biological Age Estimate Prediction Accuracy
Ramy czasowe: Periodically from enrollment until death, up to 100 years
Concordance between investigational biological age estimate and actual mortality outcomes at longitudinal follow-up.
Periodically from enrollment until death, up to 100 years
Health Behavior Change: Composite Self-Report and Repeat Screening Index
Ramy czasowe: Periodically from enrollment until death, up to 100 years
Health behavior change assessed through two complementary measures aggregated into a single index: validated composite self-report survey administered at periodic follow-up, and change in pre-specified clinical measurements at repeat screening. Improvement in objective clinical measurements (cardiorespiratory fitness, body composition, metabolic biomarkers, and related parameters) serves as the primary behavioral activation signal. Self-report domains including health behaviors and preventive care utilization provide supporting context. Both are combined into a single participant-level health activation index. Higher scores indicate greater engagement with health-promoting behaviors and measurable clinical improvement.
Periodically from enrollment until death, up to 100 years
Multi-System Predictor Modeling: Predictive Performance
Ramy czasowe: Periodically from enrollment until death, up to 100 years
Performance of a unified multi-domain measurement framework in predicting all-cause mortality and incident serious disease. The framework integrates clinical, biological, behavioral, social, occupational, and environmental data into a single composite model. Performance is reported for the full composite model, with pre-specified secondary reporting for individual predictor domains and domain combinations to identify which inputs are independently predictive, which are redundant, and which combinations provide additive or synergistic predictive value. Metrics are specified in the statistical analysis plan.
Periodically from enrollment until death, up to 100 years

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Śledczy

  • Główny śledczy: William E Brandenburg, MD, Longevity Metrics, Inc.

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

9 lutego 2025

Zakończenie podstawowe (Szacowany)

31 grudnia 2099

Ukończenie studiów (Szacowany)

31 grudnia 2099

Daty rejestracji na studia

Pierwszy przesłany

11 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

30 kwietnia 2026

Pierwszy wysłany (Rzeczywisty)

4 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

8 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • 100Year
  • IORG0012336 (Inny identyfikator: OHRP)
  • IRB00014601 (Inny identyfikator: OHRP)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Individual participant data are not shared. The complete participant record includes facial and voice recordings, genomic data, and neighborhood-resolution geography, and cannot be de-identified; it is never released. Identifiable data are accessed only by approved researchers working within Longevity Metrics secure facilities under data use agreements, with no data removed. Specific derived, aggregate, and statistical outputs are de-identified to HIPAA Safe Harbor standards and may be published, shared with collaborators, or contributed to open-access research databases. Models, risk estimates, and analytic findings derived from the research data may be provided to external organizations or used commercially; no participant record and no dataset containing participant data is transferred.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .