Molecular Indicators of Systematic Fitness
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVO Health, Inc.
About this trial
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:
1. Can a multi-analyte blood panel accurately predict directly measured VO₂max/VO₂peak? 2. How do these blood-based features vary across age, sex, and self-reported or documented physical activity profiles? 3. Are the predictor analytes able to capture changes in VO₂max/VO₂peak caused by a self-directed intervention (e.g., training for a marathon)? 4. What is the analytic reliability of the predictor biomarkers?
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
There is no intervention.
Other interventionThe 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
Day 12
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.
Time frame
From day 1 through study completion, average of 3 monthsSponsors and contacts
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Source ClinicalTrials.gov