Acute ExercisePhase 1/2NCT06217068
Comparative Analysis of Biomarkers in Response to Acute Moderate-Intensity Activity
A Phase 1/2 study testing Elliptical Activity in people with Acute Exercise and Aerobic Exercise, run by University of Georgia at 1 site in United States.
Trial summary
The purpose of this study is to understand how college students' biomarkers change with a relatively short bout of moderate-intensity physical activity. The investigators are comparing biomarkers in between self-reported physically active and sedentary students in terms of their percent difference and change. Read more about this study
- Who is it for?
- Ages 18 to 34 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Exercise, Aerobic Exercise, Biomarkers
- What is being tested?
- Elliptical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2024to 7 Feb 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 18 to 34 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- This study will enroll full-time students at the investigator's university who are aged 18-34 years.
- Participants will be generally healthy participants, assessed using the 2020 Physical Activity Readiness Questionnaire (first 7 questions) as a screening tool. Individuals who answer "no" to all of the 7 questions will be deemed healthy enough to take part.
- Two balanced groups will be created based on self-reported current activity level, either sedentary (<30min/week of exercise) or meeting exercise guidelines (>=150min/week of exercise).
- Potential participants should be willing to complete the blood draws and the 12 minutes of moderate-intensity exercise on an elliptical machine.
- Potential participants should be able to speak and read the English language. This is so they will be able to understand the study protocols clearly.
Who cannot join
- Are allergic to nuts because the snacks provided following the blood draw may contain nut products.
- Do not have transportation and parking (if needed) to lab.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Analysis of Biomarkers in Physically Active and Sedentary College Students
The purpose of this study is to understand how college students' biomarkers change with a relatively short bout of moderate-intensity physical activity. The investigators are comparing biomarkers in between self-reported physically active and sedentary students in terms of their percent difference and change. The investigators are also studying physically active versus sedentary college students' mental health. This is a mentored student research project in the investigator's lab (not part of a thesis, dissertation, or other coursework requirements), where multiple students have developed research questions using the same study design.
Read the detailed description
This study will use a two-group (sedentary versus active) pre-test, post-test study design. Following the informed consent process, participants will complete the pre-test data collection protocol including the first venipuncture blood draw for ammonia, insulin, cortisol, and c-reactive protein, first finger stick blood sample for glucose measurement, reporting of food eaten for the day as well as transportation methods to the study site. Resting heart rate will be measured.
Following a 15-minute waiting period to minimize potential effects from the blood draw, participants will walk with a study team member to a reserved elliptical machine. For the exercise component, the lab member will emphasize to the participant about maintaining the desired heart rate for moderate intensity exercise. The participant will use the elliptical for 12 minutes, without music, conversation, or general entertainment. Appropriate warm-up and cool-down is added in to the exercise time (the first two minutes and last two minutes) with preference of moderate intensity exercise lasting 8 minutes.
Participants will then walk with the study team member back to the Lab for post-test data collection. Post-test data collection follows the same procedures as pre-test data collection. Participants also will take a mental health questionnaire.
- Conditions
- Acute Exercise, Aerobic Exercise, Biomarkers
- Being tested
- Elliptical Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elliptical ActivityBehavioural
8 minutes of elliptical exercise at a moderate intensity based on heart rate reserve. There will be a 2-minute warm-up and 2-minute cool down period in addition to the 8 minutes at moderate-intensity.
| Study group | Role | What they receive |
|---|---|---|
| Sedentary Individuals - Acute Moderate-Intensity Exercise | Experimental | 8 minutes of elliptical exercise at a moderate intensity based on heart rate reserve. There will be a 2-minute warm-up and 2-minute cool down period in addition to the 8 minutes at moderate-intensity. Receives: Behavioral: Elliptical Activity |
| Active Individuals - Acute Moderate-Intensity Exercise | Experimental | 8 minutes of elliptical exercise at a moderate intensity based on heart rate reserve. There will be a 2-minute warm-up and 2-minute cool down period in addition to the 8 minutes at moderate-intensity. Receives: Behavioral: Elliptical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ammonia
Blood sample
Measured: Pre-test and post-test (immediately following exercise)
Insulin
Blood sample
Measured: Pre-test and post-test (immediately following exercise)
Cortisol
Blood sample
Measured: Pre-test and post-test (immediately following exercise)
C-reactive protein
Blood sample
Measured: Pre-test and post-test (immediately following exercise)
Glucose
Blood sample
Measured: Pre-test and post-test (immediately following exercise)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start11 Mar 2024
- Primary completion7 Feb 2025
- Study completion7 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute ExerciseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two group pre-test post-test study where groups are determined by current activity level (sedentary versus active). The dose of exercise is being tested between groups to see if there are differential effects of this acute dose at this intensity on biomarkers.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Gay, University of Georgia
- Investigators
- Jennifer L Gay, PhD, Principal investigator, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06217068
- Sponsor's protocol ID
- PROJECT00008178
- Status last verified
- Feb 2025
- First submitted
- 10 Jan 2024
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not anticipate sharing individual, identified data to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Biomarkers in Physically Active and Sedentary College Students
- ClinicalTrials.gov ID
- NCT06217068
- Acronym / sponsor ID
- PROJECT00008178
- Conditions
- Acute Exercise, Aerobic Exercise, Biomarkers
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 7 Feb 2025 (actual)
- Study completion
- 7 Feb 2025 (actual)
- First posted
- 22 Jan 2024 (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 purpose of this study is to understand how college students' biomarkers change with a relatively short bout of moderate-intensity physical activity. The investigators are comparing biomarkers in between self-reported physically active and sedentary students in terms of their percent difference and change. The investigators are also studying physically active versus sedentary college students' mental health. This is a mentored student research project in the investigator's lab (not part of a thesis, dissertation, or other coursework requirements), where multiple students have developed research questions using the same study design.
Detailed description
This study will use a two-group (sedentary versus active) pre-test, post-test study design. Following the informed consent process, participants will complete the pre-test data collection protocol including the first venipuncture blood draw for ammonia, insulin, cortisol, and c-reactive protein, first finger stick blood sample for glucose measurement, reporting of food eaten for the day as well as transportation methods to the study site. Resting heart rate will be measured.
Following a 15-minute waiting period to minimize potential effects from the blood draw, participants will walk with a study team member to a reserved elliptical machine. For the exercise component, the lab member will emphasize to the participant about maintaining the desired heart rate for moderate intensity exercise. The participant will use the elliptical for 12 minutes, without music, conversation, or general entertainment. Appropriate warm-up and cool-down is added in to the exercise time (the first two minutes and last two minutes) with preference of moderate intensity exercise lasting 8 minutes.
Participants will then walk with the study team member back to the Lab for post-test data collection. Post-test data collection follows the same procedures as pre-test data collection. Participants also will take a mental health questionnaire.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two group pre-test post-test study where groups are determined by current activity level (sedentary versus active). The dose of exercise is being tested between groups to see if there are differential effects of this acute dose at this intensity on biomarkers.
| Arm | Type | Receives |
|---|---|---|
| Sedentary Individuals - Acute Moderate-Intensity Exercise | Experimental | Behavioral: Elliptical Activity8 minutes of elliptical exercise at a moderate intensity based on heart rate reserve. There will be a 2-minute warm-up and 2-minute cool down period in addition to the 8 minutes at moderate-intensity. |
| Active Individuals - Acute Moderate-Intensity Exercise | Experimental | Behavioral: Elliptical Activity8 minutes of elliptical exercise at a moderate intensity based on heart rate reserve. There will be a 2-minute warm-up and 2-minute cool down period in addition to the 8 minutes at moderate-intensity. |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- This study will enroll full-time students at the investigator's university who are aged 18-34 years.
- Participants will be generally healthy participants, assessed using the 2020 Physical Activity Readiness Questionnaire (first 7 questions) as a screening tool. Individuals who answer "no" to all of the 7 questions will be deemed healthy enough to take part.
- Two balanced groups will be created based on self-reported current activity level, either sedentary (<30min/week of exercise) or meeting exercise guidelines (>=150min/week of exercise).
- Potential participants should be willing to complete the blood draws and the 12 minutes of moderate-intensity exercise on an elliptical machine.
- Potential participants should be able to speak and read the English language. This is so they will be able to understand the study protocols clearly.
Key exclusion criteria (2 listed)
- Are allergic to nuts because the snacks provided following the blood draw may contain nut products.
- Do not have transportation and parking (if needed) to lab.
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 |
|---|---|---|
| Elliptical Activity8 minutes of elliptical exercise at a moderate intensity based on heart rate reserve. There will be a 2-minute warm-up and 2-minute cool down period in addition to the 8 minutes at moderate-intensity. | Behavioural | Active Individuals - Acute Moderate-Intensity Exercise, Sedentary Individuals - Acute Moderate-Intensity Exercise |
Primary outcome
Ammonia
Time frame: Pre-test and post-test (immediately following exercise)
Blood sample
Insulin
Time frame: Pre-test and post-test (immediately following exercise)
Blood sample
Cortisol
Time frame: Pre-test and post-test (immediately following exercise)
Blood sample
C-reactive protein
Time frame: Pre-test and post-test (immediately following exercise)
Blood sample
Glucose
Time frame: Pre-test and post-test (immediately following exercise)
Blood sample
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: No. We do not anticipate sharing individual, identified data to other researchers.
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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. This study is not recruiting at the moment.
Jennifer L Gay, PhD principal investigator
University of Georgia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Elliptical Activity in people with Acute Exercise and Aerobic Exercise, run by University of Georgia 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 20 Feb 2025. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ammonia (time frame: Pre-test and post-test (immediately following exercise)). The study lists 5 primary outcomes in all. 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 20 Feb 2025.