Recruiting

Observational Study

Sponsor:

VO Health, Inc.

Code:

NCT07393841

Conditions

Healthy Adult

Fitness Testing

Athlete

Aging

Exercise Physiology

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

There is no intervention.

Study Details

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?

Conditions

Healthy Adult

Fitness Testing

Athlete

Aging

Exercise Physiology

Study ID

NCT07393841

Start date

Jan 5, 2026

Status verified date

Feb, 2026

Completion date

May 10, 2028

Anticipated

Primary completion date

Jan 5, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Interventions

There is no intervention.

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 outcome measure

  • A multi-analyte biomarker panel to predict maximal aerobic capacity [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Brooks P Leitner, MD, PhD

443-474-7206brooks@vohealth.co

Sean P Langan, PhD

sean@vohealth.co

Locations

VO Health, Inc.

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Brooks P Leitner, MD, PhD

443-474-7206brooks@vohealth.co

Sean P Langan, PhD

sean@vohealth.co

Principal Investigator:

Brooks P Leitner, MD, PhD

More Information

Sponsor

VO Health, Inc.

Last update posted

Feb 6, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VO Health, Inc. on 2026-02-06.