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Molecular Indicators of Systematic Fitness

Molecular Indicators of Systematic Fitness

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07393841
Acronym
MISFIT
Enrollment
250
Registered
2026-02-06
Start date
2026-01-05
Completion date
2028-05-10
Last updated
2026-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Athlete, Exercise Physiology, Fitness Testing, Healthy Adult, Human Performance

Keywords

VO2peak, VO2max, cardiorespiratory fitness, proteomics, blood biomarkers, cardiovascular health, oxygen transport, exercise performance, functional capacity

Brief 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. 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?

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.

Interventions

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.

Sponsors

VO Health, Inc.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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)

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
The change in VO2max/VO2peak and a multi-analyte biomarker panel after a self-directed training program.From day 1 through study completion, average of 3 monthsIn 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.
A multi-analyte biomarker panel to predict maximal aerobic capacityDay 1The primary outcome is developing a multi-protein biomarker panel that can accurately estimate cardiorespiratory fitness from the blood.

Countries

United States

Contacts

CONTACTBrooks P Leitner, MD, PhD
brooks@vohealth.co443-474-7206
CONTACTSean P Langan, PhD
sean@vohealth.co

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026