Actively Recruiting
The Genetic and Epigenetic Signatures of Translational Aging Laboratory Testing (GESTALT)
Led by National Institute on Aging (NIA) · Updated on 2026-06-05
900
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating biomarkers, which are substances in blood and tissues, to better understand aging and its effects on quality of life. This observational study aims to explore how these biomarkers change with aging in healthy, non-healthy/non-frail, and frail adults aged 20 and older. The study also seeks to develop methods to analyze biomarker data more accurately across different cell types and tissues, and to relate these markers to physical and cognitive changes associated with aging. Participants are grouped by health status and age, including frail individuals aged 50 and above, and healthy or non-healthy/non-frail individuals starting from age 20. The study involves visits every two years, with each visit lasting three days. During these visits, participants undergo extensive testing including blood and urine collection, physical and cognitive assessments, MRI and CT scans, muscle and skin biopsies, retinal imaging, sleep studies, and specialized procedures such as cytapheresis and lumbar puncture for certain visits. Additional testing occurs starting at year 8 and continues every 10 years to monitor aging trajectories while reducing participant burden. Participants will be assessed through medical history, physical exams, EKGs, and various laboratory and imaging tests. They will complete health questionnaires and performance tests related to memory, problem-solving, muscle metabolism, and taste. Researchers will monitor biomarkers in blood, bone marrow, muscle, fat, and skin tissues alongside measures of body composition, energetics, hormone levels, inflammation, and neurological function. The primary outcome is the development of a detailed expression and protein atlas of immune cells related to aging. Participants are expected to commit to long-term follow-up, including regular visits every two years, with additional visits occurring up to every ten years.
CONDITIONS
Brief Title
Genetic and Epigenetic Signatures of Translational Aging Laboratory Testing (GESTALT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 20 years or older
- Willing to return every 2 years for study visits
- Agree to genetic (DNA/RNA) sample collection, analysis, and storage
- Good venous access for blood sampling or cytapheresis
- Weigh at least 110 pounds
- Body mass index (BMI) below 30 for healthy group; below 35 for non-healthy or frail groups
- Able to perform daily self-care and walk independently without severe symptoms (healthy group)
- Able to read and speak English
- Understand study risks and consent to participate
- Not currently pregnant or nursing
- No current acute illness or conditions that increase risks with procedures
- Eligible to undergo MRI scans without contraindications
You will not qualify if you...
- HIV infection
- Hepatitis B or C
- Active syphilis, gonorrhea, or tuberculosis requiring treatment
- Abnormal blood counts or organ function tests beyond specified limits
- Positive urine drug screen without prescribed medication approval
- Pregnancy or nursing
- Severe cognitive impairment or diagnosed dementia
- History of bleeding disorders or recent seizures
- Claustrophobia or medical conditions preventing MRI scans
- Use of chronic anticoagulants or certain medications requiring continuous treatment
- Smoking within the past 3 months
- Medical conditions such as autoimmune diseases, severe pulmonary or gastrointestinal diseases, muscle-skeletal conditions causing weakness or pain, severe psychiatric conditions needing ongoing treatment, or sensory deficits preventing testing or consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Ongoing throughout the study duration
Participants undergo collection of blood samples, PBMCs, and biopsies to study biomarkers related to aging across different tissues.
Visits every 2 years with additional visits at years 8.5, 18.5, and every 10 years thereafter
Duration - Up to 20 years or more
Participants are monitored over time to assess physiological and cognitive changes associated with aging using various imaging and functional tests.
Visits every 2 years with additional visits at years 8.5, 18.5, and every 10 years thereafter
Trial Site Locations
Total: 1 location
1
National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, United States, 21224
Actively Recruiting
Research Team
L
Linda M Zukley, Ph.D.
L
Luigi Ferrucci, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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