Molecular Indicators of Systematic Fitness (MISFIT)

February 2, 2026 updated by: VO Health, Inc.

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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • VO Health, Inc.
        • Contact:
        • Contact:
        • Principal Investigator:
          • Brooks P Leitner, MD, PhD
        • Sub-Investigator:
          • Sean P Langan, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1
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.
From day 1 through study completion, average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VO Health, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2026

Primary Completion (Estimated)

January 5, 2028

Study Completion (Estimated)

May 10, 2028

Study Registration Dates

First Submitted

January 22, 2026

First Submitted That Met QC Criteria

February 2, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 9554ed94-872a-4b5c-8a42-13e51f

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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