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NCT Number: NCT06857877

Arlington Aging Study

The goal of this observational study is to learn about the mechanisms causing functional decline with age, using magnetic resonance imaging, exercise science, integrative physiology, neuroscience, and remote monitoring.

Specific aims include:

Aim 1: Advance knowledge of the biology of aging and its impact on the prevention, progression, and prognosis of disease and disability.

Aim 2: Determine the effects of personal and societal factors on aging.

Aim 3: Examine the influence of racial/ethnic and sex differences on the biology of aging and its impact on the prevention, progression, and prognosis of disease and disability.

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Key information

Conditions

Aging

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Texas Arlington

Arlington, Texas, 76019, United States

Location status: Recruiting

Location contact

Michael Nelson, PhD

PRINCIPAL_INVESTIGATOR

Rajvi Shah, MPH

CONTACT

[email protected]

2147557343

About this study

Subjects will be asked to participate in two study visits that may last up to 5 hours each. In some cases, additional visits may be needed to accommodate their schedule, and/or the schedule of the study team. All participants will provide informed consent prior to participating in the study procedures such as demographic, medical history, risk factor assessment; questionnaires; geographic information system analysis; blood pressure measurements; assessment of aerobic exercise capacity, cognitive function; olfactory testing; Dual X-Ray absorbency, fasting followed by venous blood draw, vascular function assessment; testing of muscle strength; short physical performance battery; functional mobility; and remote monitoring. The order of procedures and visits may change depending on participant, staff, equipment, and infrastructure availability/needs. Moreover, procedures may be repeated for data quality purposes, if deemed necessary by the investigators.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Phase 1: Young healthy men and women between 18 - 30 years of age, and older men and women between 50 - 80 years of age.

Phase 2: Men and women living in Tarrant County, Texas, between 50 - 85 years of age. In addition, the investigators will study up to 120 younger men and women, between 18-30 years of age, equally divided by race/ethnicity (same as above) and sex, to serve as reference controls.

Exclusion criteria

Phase 1: Clinical diagnosis of dementia; major depression (diagnosed by a physician), visual or auditory impairments that preclude neuropsychological testing or otherwise jeopardize the health and wellbeing of the participant during testing, non-ambulatory status (i.e. less than 10 m without mobility aid), shortness of breath while performing normal activities of daily living (walking through grocery store), body mass index greater than 45 kg/m2, heart failure or cardiomyopathy, acute coronary syndrome, primary valvular heart disease, severe gait disorder due to musculoskeletal disease or neurological motor deficit (e.g. severe osteoarthritis, lower limb amputation, Parkinson's disease, major stroke with motor sequelae); daily consumption of more than two alcoholic beverages; current treatment for cancer, and estimated life expectancy less than 4 years. Inclusion/exclusion will be verified using the demographics and medical history.

Phase 2: Clinical diagnosis of dementia; major depression (diagnosed by a physician), visual or auditory impairments that preclude neuropsychological testing or otherwise jeopardize the health and wellbeing of the participant during testing, non-ambulatory status (i.e. less than 10 m without mobility aid), shortness of breath while performing normal activities of daily living (walking through grocery store), body mass index greater than 45 kg/m2, heart failure or cardiomyopathy, acute coronary syndrome, primary valvular heart disease, severe gait disorder due to musculoskeletal disease or neurological motor deficit (e.g. severe osteoarthritis, lower limb amputation, Parkinson's disease, major stroke with motor sequelae), daily consumption of more than two alcoholic beverages; current treatment for cancer, and estimated life expectancy less than 4 years. Inclusion/exclusion will be verified using the demographics and medical history.

Treatment and study plan

Primary outcomes

  1. Sense of Smell

    Time frame: Baseline

    Olfactory Testing will be assessed using the NIH Toolbox Odor Identification cards. After scratching a card and sniffing from each sample, respondents will be asked to choose the best match for each odor from pictures representing the odor sources.

  2. Blood Pressure

    Time frame: Baseline

    Blood Pressure will be measured in the sitting position using an automated blood pressure monitor. After sitting blood pressure measurements, participants will be asked to stand up to measure standing blood pressure.

  3. Street Address

    Time frame: Baseline

    Geographic information systems will assign a geocode to each participant's home address, providing latitude, and longitude coordinates based on the provided street address.

  4. Ankle Brachial Index

    Time frame: Baseline

    The Ankle Brachial Index will be noninvasively assessed using the Smartdop XT device (Koven Technology, Inc.).

  5. Pulse Wave Velocity

    Time frame: Baseline

    Arterial stiffness will be measured non-invasively with the Sphygmocor XCEL device (AtCor Medical).

  6. Flow- mediated dilation

    Time frame: Baseline

    The flow-mediated change in brachial artery diameter (i.e. flow-mediated dilation; FMD), in response to a 5-minute period of arterial occlusion will be used to assess peripheral vascular function.

  7. Steps taken

    Time frame: Baseline

    A wrist-worn continuous activity tracker (Fitbit wristband) will be worn by the subjects for 7 days.

  8. Sedentary Time

    Time frame: Baseline

    A wrist-worn continuous activity tracker with heart rate monitor (Fitbit wristband) will be worn by the subjects for 7 days.

  9. Sleep

    Time frame: Baseline

    A wrist-worn continuous activity tracker (Fitbit) will be worn by the subjects for 7 days to assess total sleep time, and sleep quality.

  10. Medical History Questionnaire

    Time frame: Baseline

    Participants will complete health history questionnaires to gain a deeper understanding of their lived experiences and past medical history.

  11. Complete blood count

    Time frame: Baseline

    Venous blood will be drawn by a trained phlebotomist and/or nurse in the fasting state. Blood will be shipped to LabCorp for processing of the complete blood count.

  12. Functional Mobility

    Time frame: Baseline

    Objective gait measurements will be obtained using a gait mat. Participants will complete 6 separate walks down the full length of the walkway; 3 walks at a preferred pace and 3 walks while performing different secondary tasks (i.e. dual-task gait) in a fixed order:

    • counting backward by ones,
    • naming animals, and
    • counting backward by sevens.

    Walking aids will be permitted.

  13. Cognitive Function

    Time frame: Baseline

    Cognitive function will be assessed using the NIH Toolbox Cognition Battery (NIHTB-CB), administered on an iPad or computer by a trained study team member.

  14. Lower extremity function

    Time frame: Baseline

    Participants will perform the Short Physical Performance Battery (SPPB). The test includes walking, the sit-to-stand test and balance.

  15. Grip strength

    Time frame: Baseline

    Grip strength will be measured following a standardized approach using a validated Jamar handgrip dynamometer (Model J00105, JAMAR Hydraulic Hand Dynamometer).

  16. Bone Density

    Time frame: Baseline

    Participants will undergo Dual X-Ray Absorbency (DEXA) to measure bone density.

  17. Interstitial glucose

    Time frame: Baseline

    A continuous glucose monitor that measures interstitial glucose will be worn by the subject for 7 days.

  18. Body Composition

    Time frame: Baseline

    Participants will undergo Dual X-Ray Absorbency (DEXA) to measure subcutaneous and visceral fat content.

  19. Ambulatory blood pressure

    Time frame: Baseline

    A wrist worn continuous blood pressure monitor (Aktiia wristband) will be worn by the subjects for 7 days for the measurement of ambulatory blood pressure.

  20. Exercise Capacity

    Time frame: Baseline

    Exercise Capacity will be assessed using the six-minute walk test.

  21. Blood lipids

    Time frame: Baseline

    Venous blood will be drawn and shipped to Labcorp for blood lipid analysis

  22. Metabolic Panel (blood)

    Time frame: Baseline

    Venous blood will be drawn and shipped to labcorp for evaluation of the metabolic panel.

  23. Apolipoprotein A

    Time frame: Baseline

    Measured by labcrop from venous blood draw.

  24. Apolipoprotein B

    Time frame: Baseline

    Analyzed by labcorp from venous blood draw.

  25. Lipoprotein A

    Time frame: Baseline

    Analyzed by labcorp from venous blood draw

  26. Blood checmistry panel

    Time frame: Baseline

    Analyzed by labcorp from venous blood draw

  27. HbA1C (blood)

    Time frame: Baseline

    Analyzed by labcorp from venous blood draw

  28. High sensitivity C reactive protein (blood)

    Time frame: Baseline

    Analyzed by labcorp from venous blood draw

  29. Genetic testing

    Time frame: Baseline

    Whole blood (approximately 25 ml) will be stored in special tubes that preserve genetic material in our -80ºC freezer. Genetic testing experiments, including targeted single variants, single gene testing, genetic panel testing, whole genome sequencing, chromosomal testing, gene expression and biochemical testing, may be performed on the samples.

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Nelson, PhD

CONTACT

[email protected]

8175130383

Rajvi Shah, MPH

CONTACT

[email protected]

2147557343

Sponsors and collaborators

Lead sponsor

The University of Texas at Arlington

Other

Registry information

Official study title

Arlington Study of Healthy Aging

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Mar 5, 2025
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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