HealthyNCT06820658
A Comparison of Neuromuscular Recruitment in Trained and Untrained Adults
An observational study of Healthy and Insulin Resistance, run by Mayo Clinic at 1 site in United States.
Trial summary
The objective of the study is to use neurological techniques to obtain quantitative measurements of nervous system control of skeletal muscle activity in adults aged 60-85 who are either long-term resistance exercisers or who are untrained. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Insulin Resistance
- What is being tested?
- Neuromuscular Test, DEXA and Mixed Meal Tolerance Test
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2025to 1 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 80 participants will be equally divided into resistance-trained and untrained groups. Participants will be matched for age, sex, and BMI. Participants are to have a fasting blood sugar under 140 mg/dL. Untrained men and women will have a hip to waist ratio of >0.85 in women or >80cm and >0.90 in men or >94cm. Participants will be from the Rochester Minnesota area aged 60-85 with a BMI 30-38.
Who may be able to join
- Participant must have a BMI between 18.5 and 38
- Participant be aged between 60 and 85
- Regularly exercises at least 5 days a week a minimum of 30 minutes per day.
- Engages in less than 2 days of exercise less than 30 minutes each day.
- Participant must use the Mayo Clinic patient online portal.
- Participant must be able to understand English without the need of an interpreter.
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- Must be willing to be contacted for research
- Participant must be willing and capable to provide consent.
- Participants shall be generally healthy as deemed acceptable by the principal investigator
- Men and women will be participant in this study. Women cannot be pregnant during this study.
Who cannot join
- Surgical History - Gastric surgery, pacemaker placement, weight loss surgery, metabolic and obstetric surgery.
- Smokers will be excluded from the study.
- Medications: Insulins, common diabetic drugs, anti-hyperglycemic drugs, beta blockers cardiac selective, beta-blockers noncardiac selective, oral steroids, opioids anti-depressants, and hormones
- Conidiations and Diagnosis: Disorder of coronary artery, hepatic failure, gastroparesis, disorder of the adrenal gland, drug related disorders, substance abuse, malignant neoplastic disease, psychotic disorders, disorder of skeletal muscle, finding of brain, chronic kidney disease, renal failure syndrome, disorder of pulmonary circulation, cerebrovascular disease, neuro developmental disorder, disorder of immune function, disorder of central nervous system.
- Participants are not to have an abnormal value as part of a lipid panel within the past 6 months.
- Participant will be excluded if they have recreational drug use or a history of alcohol abuse
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- Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
- Current or past participation within a specified timeframe in another clinical trial, as warranted by the administration of this intervention.
- Participant will be excluded if they have epilepsy.
- Participant will be excluded if they have cranial metal/device implants
- Participant will be excluded if they are pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Emmett Oldham, 507-538-7772, oldham.emmett@mayo.edu
About this study
The objective of the study is to use neurological techniques to obtain quantitative measurements of nervous system control of skeletal muscle activity in adults aged 60-85 who are either long-term resistance exercisers or who are untrained.
Read the detailed description
We propose to perform a cross-sectional study in 20-40 highly resistance-trained people and compare with 20-40 untrained people matched for age, sex, and BMI. in adults.
Participant will complete 5 study visits. In the first visit, participants will complete a screening visit in which blood will be taken to rule out inclusion and exclusion criteria. Participants will also have their body composition measured by DEXA, Meal tolerance testing, a VO2max test on a cycle ergometer, and a muscle strength test using a knee extension machine, handgrip dynamometer and muscle motion testing.
A second and third visit will be needed for meal tolerance testing will be completed and MRI of the brain.
In the fourth and fifth visits, we will use transcranial magnetic stimulation (TMS) with electromyography (EMG) to track changes in in skeletal muscle excitability following cortical stimulation.
In the third visit, TMS-EMG measurements will be repeated to access measurement reproducibility.
- Conditions
- Healthy, Insulin Resistance
- Being tested
- Neuromuscular Test, DEXA, Mixed Meal Tolerance Test, Strength Test
- Keywords
- neuromuscular, transcranial magnetic stimulation
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular TestDiagnostic test
To measure neuromuscular connectivity, Transcranial Magnetic Stimulation (TMS) will be used to stimulate regions of the cerebral cortex known to control specific muscles.
Electromyography (EMG) activity will then be measured from the following muscle groups: deltoid, biceps, extensor digitorum communis, abductor pollicis brevis, abductor digiti minimi, and first dorsal interosseous muscle.
DEXADiagnostic test
The DEXA test uses X-rays to measure how many grams of calcium and other bone minerals are packed into a segment of bone. The test also measures the amount of fat-free mass, and fat mass.
Mixed Meal Tolerance TestDiagnostic test
Fasting blood will be collected for glucose, insulin, and c-peptide. Participants will be provided with a milkshake with a fixed amount of protein, carbohydrates, and fat. Glucose, insulin, and c-peptide will be measured at multiple time points (every 10 minutes) until four hours after consumption (50% Fat, 30% Carbohydrate HO, 20% Protein). Approximately 70mls of blood will be drawn during this time
Strength TestDiagnostic test
Knee extensor strength will be tested by gradually increasing the workload on a pneumatic Keiser knee extension machine. The test will begin with a warm-up of 4-5 reps with one leg at 30-50 psi. Then the participant will increase the workload at self-selected intervals ranging from 5-20psi until a maximum effort is achieved. If a rep is failed, then the workload will be reduced by 5psi until a successful rep is performed or a workload is reached in which a successful rep had been previously achieved. Handgrip strength will be tested using a handheld dynamometer (Baseline® standard hydraulic hand dynamometer). The test is performed with the participant seated with the elbow unsupported and flexed at 90 degrees, forearm neutral, wrist held between 0-15 degrees of ulnar deviation (Horowitz, 1997). Maximum grip is the average of three 3-5 second trials.
| Study group | Role | What they receive |
|---|---|---|
| Highly resistance-trained | Not described Receives: Diagnostic Test: Neuromuscular Test; Diagnostic Test: DEXA; Diagnostic Test: Mixed Meal Tolerance Test; Diagnostic Test: Strength Test | |
| Untrained | Not described Receives: Diagnostic Test: Neuromuscular Test; Diagnostic Test: DEXA; Diagnostic Test: Mixed Meal Tolerance Test; Diagnostic Test: Strength Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyography (EMG) response following Transcranial Magnetic Stimulation (TMS)
To assess connectivity between the nervous system and skeletal muscle, we will use transcranial magnetic stimulation (TMS) coupled with electromyography (EMG). TMS uses a magnetic field to carry a short-lasting electrical current pulse into the brain where it stimulates neurons, particularly in superficial regions of cerebral cortex, and neural activities can be measured at different levels along the motor pathways (predominantly the CST). When combined with EMG, this approach will allow us to quantify changes in muscular activity after stimulating the CST and other descending tracts and to assess the neuromuscular connectivity. EMG assess the health of muscles and the nerve cells that control them (motor neurons). EMG results can reveal nerve dysfunction, muscle dysfunction or problems with nerve-to-muscle signal transmission. Motor neurons transmit electrical signals that cause muscles to contract. Electrodes will then translate signals into graphs, sounds or numerical values.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start26 Feb 2025
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, K. Sreekumaran Nair, Mayo Clinic
- Investigators
- K. S. Nair, M.D., Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820658
- Sponsor's protocol ID
- 21-000002
- Other IDs
- 1R01AG062859
- Status last verified
- Jul 2026
- First submitted
- 21 Jan 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Neuromuscular Recruitment in Trained and Untrained Adults
- ClinicalTrials.gov ID
- NCT06820658
- Acronym / sponsor ID
- 21-000002
- Conditions
- Healthy, Insulin Resistance
- Keywords
- neuromuscular, transcranial magnetic stimulation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to use neurological techniques to obtain quantitative measurements of nervous system control of skeletal muscle activity in adults aged 60-85 who are either long-term resistance exercisers or who are untrained.
Detailed description
We propose to perform a cross-sectional study in 20-40 highly resistance-trained people and compare with 20-40 untrained people matched for age, sex, and BMI. in adults.
Participant will complete 5 study visits. In the first visit, participants will complete a screening visit in which blood will be taken to rule out inclusion and exclusion criteria. Participants will also have their body composition measured by DEXA, Meal tolerance testing, a VO2max test on a cycle ergometer, and a muscle strength test using a knee extension machine, handgrip dynamometer and muscle motion testing.
A second and third visit will be needed for meal tolerance testing will be completed and MRI of the brain.
In the fourth and fifth visits, we will use transcranial magnetic stimulation (TMS) with electromyography (EMG) to track changes in in skeletal muscle excitability following cortical stimulation.
In the third visit, TMS-EMG measurements will be repeated to access measurement reproducibility.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Highly resistance-trained | – | Diagnostic Test: Neuromuscular Test, Diagnostic Test: DEXA, Diagnostic Test: Mixed Meal Tolerance Test, Diagnostic Test: Strength Test |
| Untrained | – | Diagnostic Test: Neuromuscular Test, Diagnostic Test: DEXA, Diagnostic Test: Mixed Meal Tolerance Test, Diagnostic Test: Strength Test |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 80 participants will be equally divided into resistance-trained and untrained groups. Participants will be matched for age, sex, and BMI. Participants are to have a fasting blood sugar under 140 mg/dL. Untrained men and women will have a hip to waist ratio of >0.85 in women or >80cm and >0.90 in men or >94cm. Participants will be from the Rochester Minnesota area aged 60-85 with a BMI 30-38.
Key inclusion criteria (10 listed)
- Participant must have a BMI between 18.5 and 38
- Participant be aged between 60 and 85
- Regularly exercises at least 5 days a week a minimum of 30 minutes per day.
- Engages in less than 2 days of exercise less than 30 minutes each day.
- Participant must use the Mayo Clinic patient online portal.
Key exclusion criteria (11 listed)
- Surgical History - Gastric surgery, pacemaker placement, weight loss surgery, metabolic and obstetric surgery.
- Smokers will be excluded from the study.
- Medications: Insulins, common diabetic drugs, anti-hyperglycemic drugs, beta blockers cardiac selective, beta-blockers noncardiac selective, oral steroids, opioids anti-depressants, and hormones
- Conidiations and Diagnosis: Disorder of coronary artery, hepatic failure, gastroparesis, disorder of the adrenal gland, drug related disorders, substance abuse, malignant neoplastic disease, psychotic disorders, disorder of skeletal muscle, finding of brain, chronic kidney disease, renal failure syndrome, disorder of pulmonary circulation, cerebrovascular disease, neuro developmental disorder, disorder of immune function, disorder of central nervous system.
- Participants are not to have an abnormal value as part of a lipid panel within the past 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular TestTo measure neuromuscular connectivity, Transcranial Magnetic Stimulation (TMS) will be used to stimulate regions of the cerebral cortex known to control specific muscles. Electromyography (EMG) activity will then be measured from the following muscle groups: deltoid, biceps, extensor digitorum communis, abductor pollicis brevis, abductor digiti minimi, and first dorsal interosseous muscle. | Diagnostic test | Highly resistance-trained, Untrained |
| DEXAThe DEXA test uses X-rays to measure how many grams of calcium and other bone minerals are packed into a segment of bone. The test also measures the amount of fat-free mass, and fat mass. | Diagnostic test | Highly resistance-trained, Untrained |
| Mixed Meal Tolerance TestFasting blood will be collected for glucose, insulin, and c-peptide. Participants will be provided with a milkshake with a fixed amount of protein, carbohydrates, and fat. Glucose, insulin, and c-peptide will be measured at multiple time points (every 10 minutes) until four hours after consumption (50% Fat, 30% Carbohydrate HO, 20% Protein). Approximately 70mls of blood will be drawn during this time | Diagnostic test | Highly resistance-trained, Untrained |
| Strength TestKnee extensor strength will be tested by gradually increasing the workload on a pneumatic Keiser knee extension machine. The test will begin with a warm-up of 4-5 reps with one leg at 30-50 psi. Then the participant will increase the workload at self-selected intervals ranging from 5-20psi until a maximum effort is achieved. If a rep is failed, then the workload will be reduced by 5psi until a successful rep is performed or a workload is reached in which a successful rep had been previously achieved. Handgrip strength will be tested using a handheld dynamometer (Baseline® standard hydraulic hand dynamometer). The test is performed with the participant seated with the elbow unsupported and flexed at 90 degrees, forearm neutral, wrist held between 0-15 degrees of ulnar deviation (Horowitz, 1997). Maximum grip is the average of three 3-5 second trials. | Diagnostic test | Highly resistance-trained, Untrained |
Primary outcome
Electromyography (EMG) response following Transcranial Magnetic Stimulation (TMS)
Time frame: 21 days
To assess connectivity between the nervous system and skeletal muscle, we will use transcranial magnetic stimulation (TMS) coupled with electromyography (EMG). TMS uses a magnetic field to carry a short-lasting electrical current pulse into the brain where it stimulates neurons, particularly in superficial regions of cerebral cortex, and neural activities can be measured at different levels along the motor pathways (predominantly the CST). When combined with EMG, this approach will allow us to quantify changes in muscular activity after stimulating the CST and other descending tracts and to assess the neuromuscular connectivity. EMG assess the health of muscles and the nerve cells that control them (motor neurons). EMG results can reveal nerve dysfunction, muscle dysfunction or problems with nerve-to-muscle signal transmission. Motor neurons transmit electrical signals that cause muscles to contract. Electrodes will then translate signals into graphs, sounds or numerical values.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
K. S. Nair, M.D., Ph.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Insulin Resistance, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emmett Oldham (507-538-7772, oldham.emmett@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electromyography (EMG) response following Transcranial Magnetic Stimulation (TMS) (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.