Healthy AdultMISFITNCT07393841
Molecular Indicators of Systematic Fitness
An observational study of Healthy Adult and Fitness Testing, run by VO Health, Inc. at 1 site in United States.
Trial summary
The goal of this study is to characterize associations between cardiorespiratory fitness, as measured by VO₂max/VO₂peak, and blood-based molecular measurements in adults. This is an observational study where research staff measures VO₂max/VO₂peak and collects fasted, resting blood samples on the same day. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult, Fitness Testing, Athlete
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2026to 10 May 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population includes adults from the general community who are interested in health and fitness assessment. Participants are anticipated to primarily be athletes or recreational exercisers. This study does not specifically target clinical populations; however, individuals with stable medical conditions may participate if they have documented medical clearance to safely undergo maximal exercise testing.
Who may be able to join
- Be ≥18 years old
- Be able to understand and provide informed consent (English; additional languages may be added via amendment with translated materials)
- Be willing to complete VO₂max testing, blood draw, and questionnaires.
- Be able to safely perform maximal/symptom-limited exercise testing as determined by: PAR-Q+ screening and investigator review (included as an attachment) and resting vitals screening (heart rate)
Who cannot join
- Conditions that, in the investigator's judgment, or a medical doctor, makes maximal exercise testing unsafe (e.g., unstable cardiovascular symptoms)
- Contraindications or unwillingness to undergo venipuncture
- Acute illness (fever, significant respiratory illness) at the time of testing
- Failure to comply with procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sean P Langan, PhD contact
United States1 site, 1 recruiting
- Recruiting
VO Health, Inc.
New Haven, Connecticut, 06510
Brooks P Leitner, MD, PhD, 443-474-7206, brooks@vohealth.co
Sean P Langan, PhD, sean@vohealth.co
About this study
The goal of this study is to characterize associations between cardiorespiratory fitness, as measured by VO₂max/VO₂peak, and blood-based molecular measurements in adults. This is an observational study where research staff measures VO₂max/VO₂peak and collects fasted, resting blood samples on the same day. The main questions it aims to answer are:
- Can a multi-analyte blood panel accurately predict directly measured VO₂max/VO₂peak?
- How do these blood-based features vary across age, sex, and self-reported or documented physical activity profiles?
- Are the predictor analytes able to capture changes in VO₂max/VO₂peak caused by a self-directed intervention (e.g., training for a marathon)?
- What is the analytic reliability of the predictor biomarkers?
Read the detailed description
Prospective observational cohort with baseline cross-sectional assessment; optional longitudinal follow-up with repeat VO₂max and blood collection in a subset. No intervention is assigned by the investigators. The investigators are amassing a large dataset of diverse individuals with directly measured VO2max paired with blood samples to support robust biomarker development.
- Conditions
- Healthy Adult, Fitness Testing, Athlete, Aging, Exercise Physiology, Human Performance
- Being tested
- There is no intervention.
- Keywords
- VO2peak, VO2max, cardiorespiratory fitness, proteomics, blood biomarkers, cardiovascular health, oxygen transport, exercise performance, functional capacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no intervention.Other
The investigators are not administering an intervention for this study. To opportunistically capture prospective data, the investigators give participants the option for re-testing after a period of time where participants are undergoing a self-directed intervention (i.e., no influence of the research staff), such as training for a marathon or other fitness event.
What is being measured
The primary outcome is the main question the study is designed to answer.
A multi-analyte biomarker panel to predict maximal aerobic capacity
The primary outcome is developing a multi-protein biomarker panel that can accurately estimate cardiorespiratory fitness from the blood.
Measured: Day 1
The change in VO2max/VO2peak and a multi-analyte biomarker panel after a self-directed training program.
In a subset of individuals who opt-in for a second study visit, the investigators will analyze the change in VO2max and the multi-analyte biomarker from pre- to post-testing.
Measured: From day 1 through study completion, average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start5 Jan 2026
- Primary completion5 Jan 2028 (estimated)
- Study completion10 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VO Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07393841
- Sponsor's protocol ID
- 9554ed94-872a-4b5c-8a42-13e51f
- Acronym
- MISFIT
- Status last verified
- Feb 2026
- First submitted
- 22 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared in order to protect participant privacy and confidentiality. The study was not designed with participant consent for public IPD sharing, and the data include sensitive physiological and molecular measurements. In addition, the collected data include proprietary measurements, algorithms, and analyses that are considered confidential and commercially sensitive. Only aggregate, de-identified results will be disseminated.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Indicators of Systematic Fitness
- ClinicalTrials.gov ID
- NCT07393841
- Acronym / sponsor ID
- MISFIT / 9554ed94-872a-4b5c-8a42-13e51f
- Conditions
- Healthy Adult, Fitness Testing, Athlete, Aging, Exercise Physiology, Human Performance
- Keywords
- VO2peak, VO2max, cardiorespiratory fitness, proteomics, blood biomarkers, cardiovascular health, oxygen transport, exercise performance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- VO Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 5 Jan 2028 (estimated)
- Study completion
- 10 May 2028 (estimated)
- First posted
- 6 Feb 2026 (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 goal of this study is to characterize associations between cardiorespiratory fitness, as measured by VO₂max/VO₂peak, and blood-based molecular measurements in adults. This is an observational study where research staff measures VO₂max/VO₂peak and collects fasted, resting blood samples on the same day. The main questions it aims to answer are:
- Can a multi-analyte blood panel accurately predict directly measured VO₂max/VO₂peak?
- How do these blood-based features vary across age, sex, and self-reported or documented physical activity profiles?
- Are the predictor analytes able to capture changes in VO₂max/VO₂peak caused by a self-directed intervention (e.g., training for a marathon)?
- What is the analytic reliability of the predictor biomarkers?
Detailed description
Prospective observational cohort with baseline cross-sectional assessment; optional longitudinal follow-up with repeat VO₂max and blood collection in a subset. No intervention is assigned by the investigators. The investigators are amassing a large dataset of diverse individuals with directly measured VO2max paired with blood samples to support robust biomarker development.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes adults from the general community who are interested in health and fitness assessment. Participants are anticipated to primarily be athletes or recreational exercisers. This study does not specifically target clinical populations; however, individuals with stable medical conditions may participate if they have documented medical clearance to safely undergo maximal exercise testing.
Key inclusion criteria (4 listed)
- Be ≥18 years old
- Be able to understand and provide informed consent (English; additional languages may be added via amendment with translated materials)
- Be willing to complete VO₂max testing, blood draw, and questionnaires.
- Be able to safely perform maximal/symptom-limited exercise testing as determined by: PAR-Q+ screening and investigator review (included as an attachment) and resting vitals screening (heart rate)
Key exclusion criteria (4 listed)
- Conditions that, in the investigator's judgment, or a medical doctor, makes maximal exercise testing unsafe (e.g., unstable cardiovascular symptoms)
- Contraindications or unwillingness to undergo venipuncture
- Acute illness (fever, significant respiratory illness) at the time of testing
- Failure to comply with procedures.
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 |
|---|---|---|
| There is no intervention.The investigators are not administering an intervention for this study. To opportunistically capture prospective data, the investigators give participants the option for re-testing after a period of time where participants are undergoing a self-directed intervention (i.e., no influence of the research staff), such as training for a marathon or other fitness event. | Other | – |
Primary outcome
A multi-analyte biomarker panel to predict maximal aerobic capacity
Time frame: Day 1
The primary outcome is developing a multi-protein biomarker panel that can accurately estimate cardiorespiratory fitness from the blood.
The change in VO2max/VO2peak and a multi-analyte biomarker panel after a self-directed training program.
Time frame: From day 1 through study completion, average of 3 months
In a subset of individuals who opt-in for a second study visit, the investigators will analyze the change in VO2max and the multi-analyte biomarker from pre- to post-testing.
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 6 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared in order to protect participant privacy and confidentiality. The study was not designed with participant consent for public IPD sharing, and the data include sensitive physiological and molecular measurements. In addition, the collected data include proprietary measurements, algorithms, and analyses that are considered confidential and commercially sensitive. Only aggregate, de-identified results will be disseminated.
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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.
Sean P Langan, PhD contact
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 Adult and Fitness Testing, run by VO Health, Inc. 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 4 inclusion and 4 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 6 Feb 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 Brooks P Leitner, MD, PhD (443-474-7206, brooks@vohealth.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A multi-analyte biomarker panel to predict maximal aerobic capacity (time frame: Day 1). The study lists 2 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 6 Feb 2026.