IMAT Quality in Aging

August 17, 2026 updated by: Washington University School of Medicine

Targeting Intramuscular Adipose Quality in Aging

This study will test the central hypothesis that fat within the muscle, or intramuscular adipose tissue (IMAT), exhibits elevated damage and pro-inflammatory signaling with aging, both of which are reduced by progressive resistance exercise (PRE). Sixteen older adults 65-80 years old will be recruited and complete a 12 week calf PRE intervention. Calf muscle strength, composition (measured by computed tomography) and muscle biopsies will be collected before and after the intervention. Histology, transcriptomic and secretomic tests will be completed to assess signs of damage and inflammation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Sixteen older adult (65-80 years) will be recruited from existing databases and screened for potential participation by phone. The Rapid Assessment of Physical Activity (RAPA) will be completed, to include those who are underactive (scores 3-5). Individuals who meet the inclusion criteria will attend an in-person screening where their calf muscle strength, physical performance and safety for muscle biopsy (via complete blood count with differential and prothrombin time/international normalized raio on blood draw) will be assessed. Individuals deemed safe to participate and who give informed consent will attend a second visit which will include a computed tomography (CT) scan of the lower leg and ultrasound-guided gastrocnemius muscle+IMAT biopsy. One week later, participants will begin the ankle plantarflexor-targeted progressive resistance exercise (PRE) program which will be delivered in a group Zoom format with a trained therapist 3 times per week for 12 weeks. One week following completion of the PRE program, participants will return for follow-up strength measures, CT, and biopsy. This will complete their participation. In the lab, biopsies will be subdivided for bulk ribonucleic acid sequencing (RNAseq), explant culture and histology. Bulk RNAseq will be used to identify age- and exercise-responsive genes that encode secreted proteins. These putative secreted signals will be validated by protein quantification in explant culture. The cellular origin of validated signals will then be mapped by RNA in situ hybridization (RNAscope) on the portion of the biopsy allocated to histology. Sections will also used to identify senescent cells, inflammatory macrophages and beige adipocytes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Gretchen Meyer, PhD
  • Phone Number: 1-314-286-1456
  • Email: meyerg@wustl.edu

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63108
        • Washington University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Mary Hastings, PT, DPT, MSCI, ATC
        • Principal Investigator:
          • Gretchen Meyer, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Rapid Assessment of Physical Activity scores between 3 and 5
  • Able to don and doff the weighted vest
  • Access to a smart phone and ability to navigate the phone to enter and manage a zoom intervention
  • Commitment and availability to attend a virtual 40-minute intervention 3x per week for 12 weeks

Exclusion Criteria:

  • Contraindications to radiation exposure (e.g. Women who are pregnant, previous high radiation exposure)
  • Bleeding disorders
  • Lower extremity trauma/surgery/injury or neuropathy that would impact muscle structure and function or ability to complete exercise intervention
  • Diabetes mellitus, cardiovascular disease, peripheral vascular disease, cancer, stage 4 hypertension, anemia, connective tissue disorder
  • Neurological disorder (e.g. stroke, Parkinson's disease, multiple sclerosis, spinal cord injury)
  • Medications: insulin, glucagon-like peptide-1 (GLP1) agonists, sex hormone replacement therapy, chronic NSAIDs, anticoagulation therapy, cholesterol lowering medications such as statins
  • Unable to safely perform the progressive resistance exercise (e.g. Vestibular or balance issues that make performing the intervention unsafe, severe osteoporosis or general fragility that limits weighted vest tolerance)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Calf muscle strengthening
Older adults will complete a 3x/wk, 12 week calf strengthening exercise over zoom. The intervention will be delivered in small groups. Older adult baseline data will be compared to post-intervention data to understand the impact of exercise on aging muscle and fat within the muscle
Other: Calf muscle strengthening
The calf intervention will be delivered 3x/wk for 12 weeks over zoom, in small groups. There are 3 exercises 1) standing heel rise, 2) seated heel rise, and 3) long sitting ankle plantarflexion. The exercises will be overloaded using a weighted vest, body weight, and/or theraband. Exercises will be progressed as strength improves.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Biopsy: Senescent cell density
Time Frame: Baseline and post-intervention (approximately 14 weeks after baseline)
Senescent cells will be identified by expression of β-galactosidase (b-gal) and p16 on histological sections from muscle biopsies. B-gal and p16 positive cells will be counted and normalized to the histological region of interest to obtain a measure of density (# senescent cells / mm^2).
Baseline and post-intervention (approximately 14 weeks after baseline)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total plantarflexor muscle volume (CT) (Cm^3)
Time Frame: Baseline and post-intervention (approximately 14 weeks after baseline)
Muscle volume of the calf and foot will be measured with computed tomography (CT). The participant is supine with leg extended into the (CT). Image post-processing includes removing bones and subcutaneous fat and then segmenting and measuring plantarflexor compartment muscle volume (cm^3).
Baseline and post-intervention (approximately 14 weeks after baseline)
Plantarflexor Compartment Intramuscular Fat Volume (cm^3)
Time Frame: Baseline and post-intervention (approximately 14 weeks after baseline)
Intramuscular fat volume of the calf will be measured with computed tomography (CT). The participant is supine with leg extended into the (CT). Image post-processing includes removing bones and subcutaneous fat and then segmenting and measuring plantarflexor compartment fat volume (cm^3).
Baseline and post-intervention (approximately 14 weeks after baseline)
Plantarflexor peak torque (Newton-meters)
Time Frame: Baseline and post-intervention (approximately 14 weeks after baseline)
Plantarflexor peak torque of the ankle will be assessed using isokinetic dynamometry. The participant will have a minimum of 3 practice trials to become familiar with the test. The participant will be given 3 minutes of rest and then 3 maximum plantarflexion contractions will be completed, the highest torque produced will be recorded (Newton-meters, Nm).
Baseline and post-intervention (approximately 14 weeks after baseline)
Stair Climb Power (W)
Time Frame: Baseline and post-intervention (approximately 14 weeks after baseline)
Stair climb power will be calculated by multiplying the participant's weight (N)X height of stairs (1.853 meters)/time is takes for them to climb the 10 steps.
Baseline and post-intervention (approximately 14 weeks after baseline)
Walking Speed (meters/second)
Time Frame: Baseline and post-intervention (approximately 14 weeks after baseline)
50 foot walking speed (meters/sec) will be measured. Route is 25 feet to a line, turn around, and return to start.
Baseline and post-intervention (approximately 14 weeks after baseline)
Physical Performance Test Total Score
Time Frame: Baseline and post-intervention (approximately 14 weeks after baseline)
Physical performance test total score is a composite from the following tests: bilateral feet together stance time, bilateral semi-tandem stance time, and bilateral tandem stance time, five time chair rise time, lift a book to a shelf time, don and doff a jacket time, 360 turn right and left examining stability and continuity, time to pick a nickle off the floor, 50 feet walking speed, stair climb speed. Score ranges from 32 (no fraility) to 0 (severe frailty)
Baseline and post-intervention (approximately 14 weeks after baseline)
Biopsy: Adipocyte size
Time Frame: Baseline and post-intervention (approximately 14 weeks after baseline)
Adipocyte boundaries will be identified by expression of perilipin on histological sections from muscle biopsies. Adipocyte area will be defined as the area inside a perilipin bounded shape and will be quantified for each adipocyte in the histological region of interest (mm^2).
Baseline and post-intervention (approximately 14 weeks after baseline)
Biopsy: Macrophage density
Time Frame: Baseline and post-intervention (approximately 14 weeks after baseline)
Macrophages will be identified by expression of CD206 and CD68 on histological sections from muscle biopsies. CD206 and CD68 positive cells will be counted and normalized to the histological region of interest to obtain a measure of density (# senescent cells / mm^2).
Baseline and post-intervention (approximately 14 weeks after baseline)
Biopsy: Beige adipocyte density
Time Frame: Baseline and post-intervention (approximately 14 weeks after baseline)
Beige adipocytes will be identified by expression of UCP1 on histological sections from muscle biopsies. UCP1 positive cells will be counted and normalized to the histological region of interest to obtain a measure of density (# senescent cells / mm^2).
Baseline and post-intervention (approximately 14 weeks after baseline)
Biopsy: Differentially expressed genes and pathways
Time Frame: Baseline and post-intervention (approximately 14 weeks after baseline)
Differentially expressed genes and pathways will be extracted from RNA sequencing performed on biopsy material (gene count).
Baseline and post-intervention (approximately 14 weeks after baseline)
Biopsy: cytokine secretion
Time Frame: Baseline and post-intervention (approximately 14 weeks after baseline)
Cytokines will be analyzed in the secreted medium from biopsy material using an antibody based detection method (pg/mL).
Baseline and post-intervention (approximately 14 weeks after baseline)
Biopsy: Spatially resolved gene expression
Time Frame: Baseline and post-intervention (approximately 14 weeks after baseline)
Spatially resolved gene expression will be measured on histological sections using an RNAscope (dots/cell).
Baseline and post-intervention (approximately 14 weeks after baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gretchen Meyer, PhD, Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202512046
  • 1R21AG091159-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The following for participants at baseline

  1. Demographics (Self-report responses to questionnaires for sex, age, race/ethnicity, socioeconomic status, medical history)

    The following for participants at baseline and post-treatment

  2. Clinical measures (Data collected during laboratory examination. De-identified, aggregate summary data per time point will be shared in csv file format)
  3. Strength measures (Ankle plantarflexor peak torque measurements. De-identified, aggregate summary data per time point will be shared in csv file format.)
  4. Computed tomography measures (Measurements of muscle and adipose volumes. De-identified, aggregate summary data will be shared in csv file format.)
  5. RNA sequencing, luminex secretome, histological imagines and RNA scope image

IPD Sharing Time Frame

Data will be shared as soon as possible and no later than the time of publication or at the end of the funding period, whichever comes first

IPD Sharing Access Criteria

All shared data will be de-identified and accessible in a controlled manner according to the guidance of Washington University's Human Research Protection Office (HRPO).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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