No Condition, Assessment of Healthy VolunteersIMEXNCT07188389
Immunometabolism of Exercise
A study testing Acute exercise-moderate intensity and Acute effects-heavy intensity in people with No Condition, Assessment of Healthy Volunteers, run by University of Houston at 1 site in United States.
Trial summary
This study aims to examine the effects of acute aerobic exercise and cardiorespiratory fitness on cellular metabolism of CD8+ T cells and regulatory T cells (Tregs) found in the peripheral blood of humans. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- No Condition, Assessment of Healthy Volunteers
- What is being tested?
- Acute exercise-moderate intensity and Acute effects-heavy intensity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 3 Apr 2025
- Phase
- Interventional
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women, aged 20-40 years
- individuals presenting with average (40th-60th percentile) cardiorespiratory fitness (i.e., VO2max/VO2peak) for their age and sex will be included in acute exercise experiments; individuals with VO2max/VO2peak value >20ml/kg/min will be included in cardiorespiratory fitness experiments
- individuals categorized as 'low risk' for a cardiovascular event/heart disease when screened by American College of Sports Medicine (ACSM) criteria
Who cannot join
- adults under the age of 20 and over the age of 40
- Individuals with contraindications to exercise testing will be excluded
- Individuals with musculoskeletal impairments preventing them from exercising on a cycle ergometer
- Individuals with disease history known to impact the immune system and/or systemic metabolism will be excluded, including autoimmune diseases, HIV, Hepatitis, diabetes, cancer (completed treatment within <6 months prior), hyper- or hypothyroidism
- Pregnancy
- Individuals using medications known to impact the cardiopulmonary and/or immune response to exercise with be excluded, including those using medication to control blood pressure (e.g., beta-blockers), daily steroidal and nonsteroidal anti-inflammatories (except daily aspirin), prescription allergy medication, ADHD medication (Ritalin or Adderall), thyroid medication (e.g., Levothyroxine), and chemotherapy (including treatments within the last 6 months).
- Individuals habitually using tobacco products within the last 6 months or with excessive alcohol intake (>10 drinks/week)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunometabolism of Exercise and Fitness
This study aims to examine the effects of acute aerobic exercise and cardiorespiratory fitness on cellular metabolism of CD8+ T cells and regulatory T cells (Tregs) found in the peripheral blood of humans. In addition, the study will investigate whether the effects of exercise differ based on exercise intensity, as well as whether the effects of exercise and fitness differ between subpopulations of CD8+ T cells and Tregs. Finally, the study aims to examine whether exercise- and fitness-induced changes in cell metabolism relate to changes in cell function.
- Being tested
- Acute exercise-moderate intensity, Acute effects-heavy intensity
- Keywords
- Cardiorespiratory fitness, acute exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute exercise-moderate intensityBehavioural
30 minutes of cycling exercise at moderate (90% of first ventilatory threshold)
Acute effects-heavy intensityBehavioural
Participants will cycle 30 minutes at heavy (110% of first ventilatory threshold) intensity
| Study group | Role | What they receive |
|---|---|---|
| Acute effects: Moderate Intensity Exercise | Experimental | Participants with a moderate fitness level (determined by VO2max value recorded during graded exercise test) will cycle 30minutes exercise below ventilatory threshold. Outcome measures will be compared within-subject across blood sampled before exercise, immediately after exercise, and 2h post exercise. The order of the exercise sessions (above vs below threshold) will be randomized. Receives: Behavioral: Acute exercise-moderate intensity |
| Acute effects: Heavy intensity exercise | Experimental | Participants with a moderate fitness level (determined by VO2max value recorded during graded exercise test) will bicycle 30 minutes above ventilatory threshold. Outcome measures will be compared within-subject across blood sampled before exercise, immediately after exercise, and 2h post exercise. The order of the exercise sessions (above vs below threshold) will be randomized. Receives: Behavioral: Acute effects-heavy intensity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic Function
Cellular metabolic activity and poise of T cells as measured by flow cytometry (SCENITH)
Measured: At rest, immediately after, and two hours after exercise
Immune Cell function
Stimulated IFN-gamma, perforin and IL-10 production, as measured by flow cytometry
Measured: At rest, immediately after, and two hours after exercise
Metabolic Regulation
Expression of genes involved in cellular energy metabolism, as assessed by RT-PCR
Measured: At rest, immediately after, and two hours after exercise
Mitochondrial Regulation
Mitochondrial mass and membrane potential, as assessed by flow cytometry
Measured: At rest, immediately after, and two hours after exercise
Secondary outcomes (1)
Peripheral immune cell composition
Number (concentration) of immune cell subsets in peripheral blood, as measured by hematology analyzer and flow cytometer
Measured: At rest, immediately after, and two hours after exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start1 Mar 2024
- Primary completion2 Apr 2025
- Study completion3 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No Condition, Assessment of Healthy VolunteersStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily C Lavoy, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188389
- Sponsor's protocol ID
- STUDY00004272
- Acronym
- IMEX
- Status last verified
- Apr 2026
- First submitted
- 17 Sep 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunometabolism of Exercise and Fitness
- ClinicalTrials.gov ID
- NCT07188389
- Acronym / sponsor ID
- IMEX / STUDY00004272
- Keywords
- Cardiorespiratory fitness, acute exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 2 Apr 2025 (actual)
- Study completion
- 3 Apr 2025 (actual)
- First posted
- 23 Sep 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.
This study aims to examine the effects of acute aerobic exercise and cardiorespiratory fitness on cellular metabolism of CD8+ T cells and regulatory T cells (Tregs) found in the peripheral blood of humans. In addition, the study will investigate whether the effects of exercise differ based on exercise intensity, as well as whether the effects of exercise and fitness differ between subpopulations of CD8+ T cells and Tregs. Finally, the study aims to examine whether exercise- and fitness-induced changes in cell metabolism relate to changes in cell function.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute effects: Moderate Intensity Exercise | Experimental | Behavioral: Acute exercise-moderate intensityParticipants with a moderate fitness level (determined by VO2max value recorded during graded exercise test) will cycle 30minutes exercise below ventilatory threshold. Outcome measures will be compared within-subject across blood sampled before exercise, immediately after exercise, and 2h post exercise. The order of the exercise sessions (above vs below threshold) will be randomized. |
| Acute effects: Heavy intensity exercise | Experimental | Behavioral: Acute effects-heavy intensityParticipants with a moderate fitness level (determined by VO2max value recorded during graded exercise test) will bicycle 30 minutes above ventilatory threshold. Outcome measures will be compared within-subject across blood sampled before exercise, immediately after exercise, and 2h post exercise. The order of the exercise sessions (above vs below threshold) will be randomized. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Men and women, aged 20-40 years
- individuals presenting with average (40th-60th percentile) cardiorespiratory fitness (i.e., VO2max/VO2peak) for their age and sex will be included in acute exercise experiments; individuals with VO2max/VO2peak value >20ml/kg/min will be included in cardiorespiratory fitness experiments
- individuals categorized as 'low risk' for a cardiovascular event/heart disease when screened by American College of Sports Medicine (ACSM) criteria
Key exclusion criteria (7 listed)
- adults under the age of 20 and over the age of 40
- Individuals with contraindications to exercise testing will be excluded
- Individuals with musculoskeletal impairments preventing them from exercising on a cycle ergometer
- Individuals with disease history known to impact the immune system and/or systemic metabolism will be excluded, including autoimmune diseases, HIV, Hepatitis, diabetes, cancer (completed treatment within <6 months prior), hyper- or hypothyroidism
- Pregnancy
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 |
|---|---|---|
| Acute exercise-moderate intensity30 minutes of cycling exercise at moderate (90% of first ventilatory threshold) | Behavioural | Acute effects: Moderate Intensity Exercise |
| Acute effects-heavy intensityParticipants will cycle 30 minutes at heavy (110% of first ventilatory threshold) intensity | Behavioural | Acute effects: Heavy intensity exercise |
Primary outcome
Metabolic Function
Time frame: At rest, immediately after, and two hours after exercise
Cellular metabolic activity and poise of T cells as measured by flow cytometry (SCENITH)
Immune Cell function
Time frame: At rest, immediately after, and two hours after exercise
Stimulated IFN-gamma, perforin and IL-10 production, as measured by flow cytometry
Metabolic Regulation
Time frame: At rest, immediately after, and two hours after exercise
Expression of genes involved in cellular energy metabolism, as assessed by RT-PCR
Mitochondrial Regulation
Time frame: At rest, immediately after, and two hours after exercise
Mitochondrial mass and membrane potential, as assessed by flow cytometry
1 secondary outcome
Peripheral immune cell composition
Time frame: At rest, immediately after, and two hours after exercise
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 1 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute exercise-moderate intensity and Acute effects-heavy intensity in people with No Condition, Assessment of Healthy Volunteers, run by University of Houston 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 3 inclusion and 7 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 1 May 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?
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?
Metabolic Function (time frame: At rest, immediately after, and two hours after exercise). The study lists 4 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 1 May 2026.