- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07104539
- Original Trial
Strength Training Response of Muscle in GLP-1 Users (STRONG-GLP)
January 16, 2026 updated by: Kevin Davy, Virginia Polytechnic Institute and State University
GLP-1 medication is being prescribed for weight loss.
However, GLP-1 medication may adversely affect muscle mass and muscle function.
Moreover, any loss of muscle mass or muscle function with GLP-1 treatment may impair balance and increase fall risk.
This is a particular concern among older adults already susceptible to the common muscle strength and muscle function loss with age, yet there is little evidence among this population.
This study will address a gap in knowledge regarding the effects of GLP-1 treatment on muscle mass, muscle function, and balance/fall risk among adults age 50 and older.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- 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
- Name: Kevin Davy
- Phone Number: 540-231-3487
- Email: kdavy@vt.edu
Study Contact Backup
- Name: Elaina Marinik
- Phone Number: 540-231-0923
- Email: emarinik@vt.edu
Study Locations
-
-
Virginia
-
Blacksburg, Virginia, United States, 24061
- Recruiting
- Virginia Tech
-
-
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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Age, 50y+
- Be taking GLP-1 medicine (Weygovy or Zepbound) for 1 month or less
- Weight <300 lb
- Pass a health and exercise readiness screening
Exclusion Criteria:
- Age <50
- Weight >300 lb
- Osteoporosis
- Active metabolic, neoplastic, or cardiovascular disease
- Unable or unwilling to provide consent
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Strenth Training
Participants will undergo strength training 3 times per week for 14 weeks.
|
Participants taking a GLP-1 will undergo a 14-week strength training regimen to determine changes in muscle mass.
They will perform a series of resistance training exercises supervised by a personal trainer on 3 days per week.
|
|
Other: Waitlisted control
Participants will have no strength training intervention for 14 weeks.
Participants will be offered the same 14-week strength training program after the initial 14 weeks.
|
Participants will be waitlisted and receive the 14-week strength training intervention at the end of the waitlist period.
During the waitlist period, participants will get no intervention and then be offered the strength training intervention after the first 14 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle mass by d3-creatine dilution
Time Frame: Water containing creatine isotope consumed in lab; Urine sample collection on Day 0 and Day 3 at baseline and 14 weeks.
|
Participants will collect a urine sample prior to be provided a creatine capsule containing 30 milligrams of a naturally-occurring creatine isotope.
A glass of water will be provided to wash it down.
Participants will be asked to return ~3 days later to provide another urine sample.
Urine samples will be analyzed at an off-site laboratory to determine changes in d3-creatine excretion before and after the 14-week strength training intervention.
|
Water containing creatine isotope consumed in lab; Urine sample collection on Day 0 and Day 3 at baseline and 14 weeks.
|
|
Balance testing - Percentage of failed recoveries
Time Frame: 2-hour testing session in lab at baseline and 14 weeks.
|
Participants will stand on the treadmill with the belt stationary.
The belt will then suddenly change to a speed specified by the investigator, and the participant will attempt to step to maintain their balance and establish a stable gait.
In addition to the treadmill itself, this system includes an integrated fall arrest harness that is anchored to an overhead gantry that is fixed to the treadmill.
This harness prevents any body part but the feet from impacting the treadmill in the event that the participant is unable to maintain their balance after a sudden change in speed.
|
2-hour testing session in lab at baseline and 14 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle function
Time Frame: 500-meter timed walk in lab at baseline and 14 weeks
|
Participants will walk 500 meters down and back along a hallway at a self-selected pace.
The walk will be measured, supervised, and timed by lab personnel.
|
500-meter timed walk in lab at baseline and 14 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kevin Davy, Virginia Polytechnic Institute and State University
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 (Actual)
October 8, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
May 1, 2027
Study Registration Dates
First Submitted
July 29, 2025
First Submitted That Met QC Criteria
July 29, 2025
First Posted (Actual)
August 5, 2025
Study Record Updates
Last Update Posted (Actual)
January 21, 2026
Last Update Submitted That Met QC Criteria
January 16, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nutrition Disorders
- Overnutrition
- Body Weight
- Body Weight Changes
- Overweight
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Obesity
- Weight Loss
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Physical Therapy Modalities
- Patient Care
- Exercise Therapy
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Physical Conditioning, Human
- Exercise
- Resistance Training
Other Study ID Numbers
- 25-707
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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