NCT06857877

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
770

participants targeted

Target at P75+ for all trials

Timeline
55mo left

Started Sep 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Sep 2024Dec 2030

Study Start

First participant enrolled

September 1, 2024

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2024

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 5, 2025

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

6.3 years

First QC Date

September 24, 2024

Last Update Submit

April 20, 2026

Conditions

Keywords

AgingMRICognitive FunctionExercise ScienceRemote Monitoring

Outcome Measures

Primary Outcomes (29)

  • Sense of Smell

    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.

    Baseline

  • Blood Pressure

    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.

    Baseline

  • Street Address

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

    Baseline

  • Ankle Brachial Index

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

    Baseline

  • Pulse Wave Velocity

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

    Baseline

  • Flow- mediated dilation

    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.

    Baseline

  • Steps taken

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

    Baseline

  • Sedentary Time

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

    Baseline

  • Sleep

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

    Baseline

  • Medical History Questionnaire

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

    Baseline

  • Complete blood count

    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.

    Baseline

  • Functional Mobility

    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: 1. counting backward by ones, 2. naming animals, and 3. counting backward by sevens. Walking aids will be permitted.

    Baseline

  • Cognitive Function

    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.

    Baseline

  • Lower extremity function

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

    Baseline

  • Grip strength

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

    Baseline

  • Bone Density

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

    Baseline

  • Interstitial glucose

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

    Baseline

  • Body Composition

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

    Baseline

  • Ambulatory blood pressure

    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.

    Baseline

  • Exercise Capacity

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

    Baseline

  • Blood lipids

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

    Baseline

  • Metabolic Panel (blood)

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

    Baseline

  • Apolipoprotein A

    Measured by labcrop from venous blood draw.

    Baseline

  • Apolipoprotein B

    Analyzed by labcorp from venous blood draw.

    Baseline

  • Lipoprotein A

    Analyzed by labcorp from venous blood draw

    Baseline

  • Blood checmistry panel

    Analyzed by labcorp from venous blood draw

    Baseline

  • HbA1C (blood)

    Analyzed by labcorp from venous blood draw

    Baseline

  • High sensitivity C reactive protein (blood)

    Analyzed by labcorp from venous blood draw

    Baseline

  • Genetic testing

    Whole blood (approximately 25 ml) will be stored in special tubes that preserve genetic material in our -80ÂșC 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.

    Baseline

Study Arms (1)

Older Adults

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult men and women currently living in Tarrant County will be contacted through IRB approved flyers, targeted ads (social media), and/or word-of-mouth.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Arlington

Arlington, Texas, 76019, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood will be stored in special tubes that preserve genetic material. 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.

Central Study Contacts

Michael Nelson, PhD

CONTACT

Rajvi Shah, MPH

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 24, 2024

First Posted

March 5, 2025

Study Start

September 1, 2024

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

April 23, 2026

Record last verified: 2026-04

Locations