- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07799662
VO2max and Substrate Crossover Point (VO2MAX-CROSS)
Higher VO2max Delays Substrate Switching and Shifts the Crossover Point to Greater Oxygen Uptake During Incremental Exerciseebys
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study evaluates the relationship between maximal oxygen uptake (VO2max) and the substrate crossover point during incremental treadmill exercise in young, physically active individuals. Substrate utilization kinetics and metabolic flexibility represent critical components of cardiovascular conditioning and endurance performance; however, the impact of continuous variations in aerobic capacity on the onset of metabolic transition requires detailed investigation.
Participants undergo anthropometric testing followed by a maximal graded exercise test on a motor-driven treadmill following the standard Bruce protocol. Breath-by-breath expired gas analysis using indirect calorimetry continuously monitors oxygen uptake (VO2), carbon dioxide production (VCO2), and minute ventilation (VE) throughout the test. Respiratory exchange ratio (RER) values are calculated continuously. The substrate crossover point is operationally defined as the exercise intensity corresponding to an RER threshold of 0.85, representing the metabolic transition where carbohydrate oxidation becomes the predominant contributor to total energy expenditure over lipid oxidation.
Key outcome measures extracted at this threshold include:
Time to reach the crossover point (minutes)
Absolute oxygen uptake at crossover (liters per minute [L/min])
Relative oxygen uptake at crossover (milliliters per kilogram per minute [mL/kg/min])
Percentage of maximal oxygen uptake at crossover (%VO2max)
Heart rate at crossover (beats per minute [bpm])
Statistical associations between maximal aerobic capacity (VO2max) and the primary outcome measures at the crossover point are analyzed using linear correlation and regression models to determine how cardiorespiratory fitness alters substrate switching kinetics under progressive physical strain.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tepebaşi
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Eskişehir, Tepebaşi, Turkey (Türkiye), 26100
- Eskişehir Technical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy male or female physical education students aged 18 to 30 years
- Regularly physically active (participating in structured physical activity at least 3 days per week)
- Medically cleared and capable of performing maximal graded treadmill exercise testing to voluntary exhaustion
- Willing and able to provide written informed consent
Exclusion Criteria:
- History of cardiovascular, pulmonary, metabolic, renal, or neuromuscular disorders
- Acute musculoskeletal injury or orthopedic condition that impairs treadmill running or maximal exertion
- Current use of prescription medications, stimulants, or dietary supplements known to alter metabolic rate, heart rate, or substrate oxidation
- Use of tobacco, nicotine products, or alcohol within 24 hours prior to testing
- Consumption of caffeine or vigorous physical exercise within 24 hours prior to the exercise trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Exercise Testing Group
: Healthy young adult participants who undergo a single maximal incremental treadmill exercise test using the Bruce Protocol to assess cardiorespiratory fitness (VO2max) and substrate crossover kinetics.
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Participants perform a maximal treadmill exercise test following the standardized Bruce Protocol.
The test begins with a warm-up, followed by progressive 3-minute stages with continuous increases in speed and incline until voluntary exhaustion.
Indirect calorimetry is used continuously via breath-by-breath gas analysis to measure VO2VCO2, and RER for substrate crossover determination.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Time to reach the substrate crossover point
Time Frame: Time Frame: Baseline (single test session, Day 1)
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Measure Description: Elapsed time (in minutes) from the start of the incremental treadmill test (Bruce protocol) to the point where the respiratory exchange ratio (RER) reaches 0.85, indicating the metabolic crossover where carbohydrate oxidation becomes the predominant fuel source. Time Frame: Baseline (single exercise test session, Day 1) Unit of Measure: Minutes |
Time Frame: Baseline (single test session, Day 1)
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Relative oxygen uptake at the crossover point
Time Frame: Measure Description: Measured continuously during the incremental exercise test using indirect calorimetry, recorded specifically at the point where the respiratory exchange ratio (RER) reaches 0.85. Time Frame: Baseline
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Measure Title: Relative oxygen uptake at the substrate crossover point Measure Description: Oxygen uptake (VO2) normalized to body weight (mL/kg/min) recorded at the moment the substrate crossover point (respiratory exchange ratio [RER] = 0.85) is reached during the maximal incremental treadmill test (Bruce protocol). Time Frame: Baseline |
Measure Description: Measured continuously during the incremental exercise test using indirect calorimetry, recorded specifically at the point where the respiratory exchange ratio (RER) reaches 0.85. Time Frame: Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Percentage of VO2max at the crossover point
Time Frame: Measure Description: Relative oxygen uptake (VO2) at the substrate crossover point (respiratory exchange ratio [RER] = 0.85) expressed as a % of the participant's maximal oxygen uptake (VO2max), calculated upon completion of the Bruce protocol
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Measure Title: Percentage of maximal oxygen uptake at the substrate crossover point Measure Description: Relative oxygen uptake (VO2) at the substrate crossover point (respiratory exchange ratio [RER] = 0.85) expressed as a percentage (%) of the participant's maximal oxygen uptake (VO2max) during the Bruce protocol treadmill test. Time Frame: Baseline |
Measure Description: Relative oxygen uptake (VO2) at the substrate crossover point (respiratory exchange ratio [RER] = 0.85) expressed as a % of the participant's maximal oxygen uptake (VO2max), calculated upon completion of the Bruce protocol
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Heart rate at the crossover point
Time Frame: Measure Description: Heart rate (HR) in beats per minute (bpm) measured continuously during the incremental treadmill test (Bruce protocol), recorded at the substrate crossover threshold (respiratory exchange ratio [RER] = 0.85). Time Frame: Baseline
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Measure Title: Heart rate at the substrate crossover point Measure Description: Heart rate (HR) recorded in beats per minute (bpm) using a telemetric heart rate monitor at the point where the substrate crossover threshold (respiratory exchange ratio [RER] = 0.85) is achieved during the maximal incremental treadmill test (Bruce protocol). Time Frame: Baseline |
Measure Description: Heart rate (HR) in beats per minute (bpm) measured continuously during the incremental treadmill test (Bruce protocol), recorded at the substrate crossover threshold (respiratory exchange ratio [RER] = 0.85). Time Frame: Baseline
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Maximal oxygen consumption (VO2max)
Time Frame: Measure Description: Relative maximal oxygen uptake (VO2max in mL/kg/min) assessed at maximal exertion at the end of the Bruce protocol treadmill test to voluntary exhaustion via indirect calorimetry. Time Frame: Baseline
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Measure Description: The highest rate of relative oxygen uptake (VO2 in mL/kg/min) attained during the maximal graded exercise test (Bruce protocol) to voluntary exhaustion via indirect calorimetry. Time Frame: Baseline |
Measure Description: Relative maximal oxygen uptake (VO2max in mL/kg/min) assessed at maximal exertion at the end of the Bruce protocol treadmill test to voluntary exhaustion via indirect calorimetry. Time Frame: Baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: celil kaçoğlu, Ph.D., Eskişehir Teknik Üniversitesi
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- EskisehirTU-SBF-CK-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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