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NCT Number: NCT07393841

Molecular Indicators of Systematic Fitness

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?

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Key information

Conditions

Healthy Adult Aging Athlete Exercise Physiology Fitness Testing Human Performance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

VO Health, Inc.

New Haven, Connecticut, 06510, United States

Location status: Recruiting

Location contact

Brooks P Leitner, MD, PhD

CONTACT

[email protected]

443-474-7206

Brooks P Leitner, MD, PhD

PRINCIPAL_INVESTIGATOR

Sean P Langan, PhD

CONTACT

[email protected]

Sean P Langan, PhD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Brooks P Leitner, MD, PhD

CONTACT

[email protected]

443-474-7206

Sean P Langan, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

VO Health, Inc.

Industry

Registry information

Acronym: MISFIT

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 6, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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