Molecular Indicators of Systematic Fitness

NCT07393841 | Recruiting

• 1 other identifier: 9554ed94-872a-4b5c-8a42-13e51f
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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. 1.Can a multi-analyte blood panel accurately predict directly measured VO₂max/VO₂peak?
2. 2.How do these blood-based features vary across age, sex, and self-reported or documented physical activity profiles?
3. 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. 4.What is the analytic reliability of the predictor biomarkers?

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; functional capacity

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From day 1 through study completion, average of 3 months

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• VO Health, Inc.: lead

Study Sites (1)

VO Health, Inc.

New Haven, Connecticut, 06510, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

The investigators are retaining two types of plasma (K2 EDTA and protease inhibitor tubes), serum, and whole blood (PAXgene).

Central Study Contacts

Brooks P Leitner, MD, PhD

CONTACT

443-474-7206; brooks@vohealth.co

Sean P Langan, PhD

CONTACT

sean@vohealth.co

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: February 6, 2026
• Study Start: January 5, 2026
• Primary Completion (Estimated): January 5, 2028
• Study Completion (Estimated): May 10, 2028
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)