[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07393841":3,"trial-entities:NCT07393841":101,"trial-summary:NCT07393841":104},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":24,"study_type":34,"primary_purpose":35,"phases":36,"enrollment_info":37,"interventions":40,"primary_outcomes":45,"secondary_outcomes":54,"sex":55,"minimum_age":56,"maximum_age":35,"healthy_volunteers":57,"eligibility_criteria":58,"std_ages":70,"locations":73,"central_contacts":95,"overall_officials":98,"references":99,"see_also_links":100},"NCT07393841","9554ed94-872a-4b5c-8a42-13e51f","Molecular Indicators of Systematic Fitness","RECRUITING","2028-05-10","2026-02","2026-02-06","2026-01-05","VO Health, Inc.","INDUSTRY",false,"The goal of this study is to characterize associations between cardiorespiratory fitness, as measured by VO₂max\u002FVO₂peak, and blood-based molecular measurements in adults. This is an observational study where research staff measures VO₂max\u002FVO₂peak and collects fasted, resting blood samples on the same day. The main questions it aims to answer are:\n\n1. Can a multi-analyte blood panel accurately predict directly measured VO₂max\u002FVO₂peak?\n2. How do these blood-based features vary across age, sex, and self-reported or documented physical activity profiles?\n3. Are the predictor analytes able to capture changes in VO₂max\u002FVO₂peak caused by a self-directed intervention (e.g., training for a marathon)?\n4. What is the analytic reliability of the predictor biomarkers?","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.",[18,19,20,21,22,23],"Healthy Adult","Fitness Testing","Athlete","Aging","Exercise Physiology","Human Performance",[25,26,27,28,29,30,31,32,33],"VO2peak","VO2max","cardiorespiratory fitness","proteomics","blood biomarkers","cardiovascular health","oxygen transport","exercise performance","functional capacity","OBSERVATIONAL",null,[],{"count":38,"type":39},250,"ESTIMATED",[41],{"type":42,"name":43,"description":44},"OTHER","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.",[46,50],{"measure":47,"description":48,"timeFrame":49},"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",{"measure":51,"description":52,"timeFrame":53},"The change in VO2max\u002FVO2peak 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",[],"ALL","18 Years",true,{"inclusion":59,"exclusion":64,"raw_text":69},[60,61,62,63],"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\u002Fsymptom-limited exercise testing as determined by: PAR-Q+ screening and investigator review (included as an attachment) and resting vitals screening (heart rate)",[65,66,67,68],"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.","Inclusion Criteria:\n\n* Be ≥18 years old\n* Be able to understand and provide informed consent (English; additional languages may be added via amendment with translated materials)\n* Be willing to complete VO₂max testing, blood draw, and questionnaires.\n* Be able to safely perform maximal\u002Fsymptom-limited exercise testing as determined by: PAR-Q+ screening and investigator review (included as an attachment) and resting vitals screening (heart rate)\n\nExclusion Criteria:\n\n* Conditions that, in the investigator's judgment, or a medical doctor, makes maximal exercise testing unsafe (e.g., unstable cardiovascular symptoms)\n* Contraindications or unwillingness to undergo venipuncture\n* Acute illness (fever, significant respiratory illness) at the time of testing\n* Failure to comply with procedures.",[71,72],"ADULT","OLDER_ADULT",[74],{"facility":12,"status":7,"city":75,"state":76,"zip":77,"country":78,"contacts":79,"geoPoint":92},"New Haven","Connecticut","06510","United States",[80,85,88,90],{"name":81,"role":82,"phone":83,"email":84},"Brooks P Leitner, MD, PhD","CONTACT","443-474-7206","brooks@vohealth.co",{"name":86,"role":82,"email":87},"Sean P Langan, PhD","sean@vohealth.co",{"name":81,"role":89},"PRINCIPAL_INVESTIGATOR",{"name":86,"role":91},"SUB_INVESTIGATOR",{"lat":93,"lon":94},41.30815,-72.92816,[96,97],{"name":81,"role":82,"phone":83,"email":84},{"name":86,"role":82,"email":87},[],[],[],{"nct_id":4,"conditions":102,"biomarkers":103},[18],[],{"nct_id":4,"found":57,"summary":105,"prompt_version":115},{"design":106,"status":107,"heading":108,"summary":109,"follow_up":110,"word_count":111,"commitments":112,"compensation":113,"drugs_mentioned":114},"This is an observational study with a planned enrollment of 250 participants. It involves a baseline assessment and optional follow-up for some participants.","completed","Observational Study of Fitness and Blood Markers","This observational study aims to understand the connection between your cardiorespiratory fitness (how well your heart and lungs work, measured by VO2max\u002FVO2peak) and certain markers in your blood. Researchers want to see if a blood test can accurately predict your fitness level and how these blood markers change with age, sex, and physical activity. They also want to know if these markers can show improvements in fitness from your own exercise program. You can join if you are an adult, at least 18 years old, and can safely perform exercise testing. The study plans to enroll 250 healthy adults, athletes, and people interested in exercise physiology. There is no intervention given by the study team.","Optional follow-up for a subset of participants, with re-testing after an average of 3 months.",115,"You would complete VO2max testing, have a blood draw, and fill out questionnaires. Some participants may have repeat testing after about 3 months.","Not stated in the trial record.",[],"v2"]