Actively Recruiting

Age: 20Years - 120Years
All Genders
Healthy Volunteers
NCT02339012

Genetic and Epigenetic Signatures of Translational Aging Laboratory Testing (GESTALT)

Led by National Institute on Aging (NIA) · Updated on 2026-05-08

900

Participants Needed

1

Research Sites

4424 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Background: \- Biomarkers are substances in people s blood and tissues. They help researchers understand diseases and signs of aging. Scientists want to do more research on biomarkers to find ways to improve quality of life in old age. Objective: \- To learn more about biomarkers and their relationship to aging. Eligibility: \- Adults at least 20 years old who weigh at least 110 pounds and have a body mass index below 30. They must agree that their genetic samples can be collected, studied, and stored. Design: * Participants will be screened with medical history, physical exam, EKG and blood and urine tests. * Participants will have 3-day visits. They will return every 2 years. * All visits include: * Blood and urine collection * Physical performance tests * Health questionnaires * Memory and problem-solving tests * Magnetic Resonance Imaging (MRI) and Computerized Tomography (CT) scans. * Muscle metabolism/ exercise tests * Taste strips * Muscle and/or skin biopsies/ red light therapy * Retinal imaging/ eye tracking * Sleep study * ODD visits also include: * Cytapheresis * Bone marrow aspirate * EVEN visits also include: * Hyperglycemic CLAMP * Lumbar Puncture (LP) * Continuous Glucose Monitor (CGM)

CONDITIONS

Official Title

Genetic and Epigenetic Signatures of Translational Aging Laboratory Testing (GESTALT)

Who Can Participate

Age: 20Years - 120Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 20 years or older for Healthy and Non-Healthy-or-Frail groups; 50 years or older for Frail group
  • Willing to return every 2 years for study visits
  • Agree to genetic sample collection, analysis, and storage
  • Healthy group: weigh at least 110 lbs and BMI less than 30; Non-Healthy-or-Frail and Frail groups: weigh at least 110 lbs and BMI 35 or below
  • Good venous access for blood sampling; Healthy group requires good venous access for cytapheresis
  • No established genetic diseases like sickle cell, hemochromatosis, cystic fibrosis, or Ehlers-Danlos syndrome
  • No autoimmune diseases such as Hashimoto's thyroiditis, Myasthenia Gravis, or Rheumatoid arthritis (Healthy group)
  • Able to perform daily self-care without assistance (Healthy group)
  • Able to walk independently for at least 400 meters without severe symptoms (Healthy group)
  • Able to perform normal daily activities without severe shortness of breath or symptoms (Healthy group)
  • No cognitive impairment or dementia
  • No history of cardiovascular or cerebrovascular disease (Healthy group)
  • No history of diabetes requiring treatment other than diet and exercise (Healthy group)
  • No active cancer in the last 10 years except localized skin cancer (Healthy group)
  • No significant hormonal dysfunction (Healthy group)
  • No history of neurological, kidney, liver, severe gastrointestinal, pulmonary, muscle-skeletal, or severe psychiatric diseases that impair function (Healthy group)
  • No medical conditions requiring long-term continuous treatment with certain medications
  • No chronic use of anticoagulant medications except low-dose aspirin
  • No important sensory deficits preventing testing or consent
  • Able to read and speak English
  • Able to understand study procedures and consent
  • Not pregnant or nursing
  • No smoking in past 3 months (Healthy group)
  • No current illnesses increasing risk for procedures
  • No allergy to acid-citrate-dextrose anticoagulant
  • No active bleeding disorders
  • No recent seizures
  • No recent Lyme disease or certain infections
  • Not claustrophobic and eligible for MRI
  • No hip or knee replacements preventing MRI
  • Frail group meets specific frailty criteria
  • Non-Healthy-or-Frail group does not meet Healthy or Frail criteria
Not Eligible

You will not qualify if you...

  • HIV infection
  • Hepatitis B or C infection
  • Active syphilis, gonorrhea, or tuberculosis requiring treatment
  • Abnormal white blood cell counts (Healthy group only)
  • Abnormal platelet counts (Healthy group only)
  • Low hemoglobin levels (Healthy group only)
  • Low kidney function: GFR under 50 for Healthy group; GFR 30 or below for Non-Healthy-or-Frail and Frail groups
  • Elevated bilirubin over 1.5 mg/dL unless due to Gilbert's disease (Healthy group only)
  • Liver enzymes (ALT, AST, alkaline phosphatase) twice the normal limit (Healthy group only)
  • Abnormal calcium levels
  • Low albumin levels (Healthy group only)
  • High cholesterol, LDL, or triglycerides above 1.5 times normal (Healthy group only)
  • Positive urine drug screen unless prescribed medication and approved by PI
  • Currently pregnant or nursing
  • Failure of urine drug screen at follow-up visits leads to ineligibility
  • Any medical condition that substantially increases risk for study procedures as judged by the physician

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

National Institute of Aging, Clinical Research Unit

Baltimore, Maryland, United States, 21224

Actively Recruiting

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Research Team

L

Linda M Zukley, Ph.D.

CONTACT

L

Luigi Ferrucci, M.D.

CONTACT

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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