- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07748429
Placebo Effect on Cycling Performance: Laboratory Crossover Study
15 września 2026 zaktualizowane przez: Poznan University of Physical Education
The Impact of Expectations on Physical Performance and Psychophysiological Potential: a Randomized, Double-blind, Placebo-controlled Crossover Study on the Placebo Effect in the Context of Caffeine Supplementation
This study aims to determine the impact of the placebo (PLA) effect on physical and cognitive performance in a controlled laboratory setting.
The study investigates how expectations and beliefs about substance intake (caffeine vs. placebo) interact with actual consumption to influence performance and physiological stress markers.
Healthy adults (n = 80) will participate in four testing sessions using a randomized, double-blind, placebo-controlled crossover design.
Physiological stress markers (cortisol and alpha-amylase), heart rate, and performance metrics will be monitored during a standardized cycling exercise protocol.
This phase provides the dense mechanistic data required to refine a mathematical model of the placebo effect, offering insights into how individual personality traits and cognitive anchoring influence psychophysiological potential.
Przegląd badań
Status
Jeszcze nie rekrutacja
Interwencja / Leczenie
Szczegółowy opis
This study employs a randomized, double-blind, placebo-controlled crossover design to conduct a multifactorial analysis of psychophysiological and biomechanical dynamics.
Participants (n = 80, aged 20-35 years) will complete four experimental sessions separated by 7-day washout periods, involving caffeine (6 mg/kg) or placebo administration.
The laboratory protocol (160 minutes) integrates multiple modalities: (1) cognitive testing (Reaction Time Test and Flanker Test), (2) postural control assessment using the BTrackS Balance Plate, and (3) a standardized cycle ergometer exercise protocol consisting of 15 minutes at the anaerobic threshold followed by a 5-minute self-paced maximal effort trial.
Belief manipulation (immediate vs. retrospective reporting) and cognitive anchoring (feedback conditions) are implemented to isolate expectancy-driven effects.
Continuous metabolic and cardiorespiratory data collected using the Cosmed K5 system will be synchronized with blood biomarkers (lactate, glucose, caffeine, and paraxanthine) and salivary biomarkers (cortisol, testosterone, and alpha-amylase).
Advanced statistical methods, including Functional Data Analysis (FDA) and machine learning, will be used to integrate physiological trajectories with behavioral predictors.
Typ studiów
Interwencyjne
Zapisy (Szacowany)
80
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Jakub Malik, PhD
- Numer telefonu: +48739975701
- E-mail: malik@awf.poznan.pl
Lokalizacje studiów
-
-
Wielkopolska
-
Poznan, Wielkopolska, Polska
- Poznań University of Physical Education
-
Kontakt:
- Jakub Malik, PhD
- Numer telefonu: +48739975701
- E-mail: malik@awf.poznan.pl
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Tak
Opis
Inclusion Criteria:
- Age between 20 and 35 years,
- Healthy adults,
- Regular physical activity, but not professional athletes,
- Normal or corrected-to-normal vision,
- Habitual caffeine consumption.
Exclusion Criteria:
- History of neurological, psychiatric, cardiovascular, or metabolic disorders,
- Current use of medication or supplements affecting the central nervous system,
- Musculoskeletal injuries that would impair physical performance,
- No habitual caffeine consumption or severe negative side effects of caffeine,
- Diagnosed sleep disorders or chronic fatigue,
- Diagnosed major depressive disorder or other severe psychiatric conditions,
- Presence of any menstrual disorders,
- Inability to attend all experimental study visits.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Podstawowa nauka
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Sequence AABB
Participants follow the sequence: Caffeine, Caffeine, Placebo, Placebo, with a 7-day washout period between sessions.
|
Anhydrous caffeine administered in an encapsulated form at a dosage of 6 mg per kilogram of body mass, 60 minutes before the exercise protocol.
Corn starch administered in an identical encapsulated form as the active caffeine, 60 minutes prior to the laboratory exercise protocol.
|
|
Eksperymentalny: Sequence BBAA
Participants follow the sequence: Placebo, Placebo, Caffeine, Caffeine, with a 7-day washout period between sessions.
|
Anhydrous caffeine administered in an encapsulated form at a dosage of 6 mg per kilogram of body mass, 60 minutes before the exercise protocol.
Corn starch administered in an identical encapsulated form as the active caffeine, 60 minutes prior to the laboratory exercise protocol.
|
|
Eksperymentalny: Sequence ABAB
Participants follow the sequence: Caffeine, Placebo, Caffeine, Placebo, with a 7-day washout period between sessions.
|
Anhydrous caffeine administered in an encapsulated form at a dosage of 6 mg per kilogram of body mass, 60 minutes before the exercise protocol.
Corn starch administered in an identical encapsulated form as the active caffeine, 60 minutes prior to the laboratory exercise protocol.
|
|
Eksperymentalny: Sequence BABA
Participants follow the sequence: Placebo, Caffeine, Placebo, Caffeine, with a 7-day washout period between sessions.
|
Anhydrous caffeine administered in an encapsulated form at a dosage of 6 mg per kilogram of body mass, 60 minutes before the exercise protocol.
Corn starch administered in an identical encapsulated form as the active caffeine, 60 minutes prior to the laboratory exercise protocol.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Physical Work Capacity (total work in J)
Ramy czasowe: Measured during each laboratory exercise protocol (approximately 85-120 minutes).
|
Total physical work performed, expressed in Joules (J), during the standardized laboratory exercise protocol, including both the Anaerobic Threshold phase and the Self-paced Maximal Time-trial.
|
Measured during each laboratory exercise protocol (approximately 85-120 minutes).
|
|
Postural Control (mm)
Ramy czasowe: Measured continuously during the exercise protocol and at T1 (minute 2), T2 (minute 55), and T3 (minute 125).
|
Center of Pressure excursions measured using the BTrackS Balance Plate and expressed in millimeters (mm).
|
Measured continuously during the exercise protocol and at T1 (minute 2), T2 (minute 55), and T3 (minute 125).
|
|
Explosive power variables (mm)
Ramy czasowe: Continuous recording throughout the exercise protocol and discrete assessments at T1 (2 minute of protocol), T2 (55 minute of protocol), and T3 (125 minute of protocol).
|
Explosive lower-limb power expressed in millimeters (mm) - Countermovement Jump - height.
|
Continuous recording throughout the exercise protocol and discrete assessments at T1 (2 minute of protocol), T2 (55 minute of protocol), and T3 (125 minute of protocol).
|
|
Psychomotor Vigilance Test Reaction Time (ms)
Ramy czasowe: Measured at T1 (pre-ingestion, minute 2 of the protocol), T2 (post-ingestion/pre-exercise, minute 55 of the protocol), and T3 (post-exercise, minute 125 of the protocol).
|
Reaction time during the Psychomotor Vigilance Test expressed in milliseconds (ms).
|
Measured at T1 (pre-ingestion, minute 2 of the protocol), T2 (post-ingestion/pre-exercise, minute 55 of the protocol), and T3 (post-exercise, minute 125 of the protocol).
|
|
Flanker Test Reaction Time (ms)
Ramy czasowe: Measured at T1 (pre-ingestion, minute 2 of the protocol), T2 (post-ingestion/pre-exercise, minute 55 of the protocol), and T3 (post-exercise, minute 125 of the protocol).
|
Reaction time during the Flanker Test expressed in milliseconds (ms).
|
Measured at T1 (pre-ingestion, minute 2 of the protocol), T2 (post-ingestion/pre-exercise, minute 55 of the protocol), and T3 (post-exercise, minute 125 of the protocol).
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Exercise Heart Rate (bpm)
Ramy czasowe: Measured continuously during each laboratory exercise protocol (approximately 85-120 minutes).
|
Heart rate expressed in beats per minute (bpm) recorded continuously throughout the standardized laboratory exercise protocol.
|
Measured continuously during each laboratory exercise protocol (approximately 85-120 minutes).
|
|
Exercise Heart Rate Variability (ms)
Ramy czasowe: Measured continuously during each laboratory exercise protocol (approximately 85-120 minutes).
|
Heart rate variability expressed in milliseconds (ms) and recorded continuously throughout the standardized laboratory exercise protocol to assess autonomic regulation.
|
Measured continuously during each laboratory exercise protocol (approximately 85-120 minutes).
|
|
Simple Reaction Time (ms)
Ramy czasowe: Measured at T1 (pre-ingestion, minute 2 of the protocol), T2 (post-ingestion/pre-exercise, minute 55 of the protocol), and T3 (post-exercise, minute 125 of the protocol).
|
Reaction time during the Simple Reaction Time test expressed in milliseconds (ms).
|
Measured at T1 (pre-ingestion, minute 2 of the protocol), T2 (post-ingestion/pre-exercise, minute 55 of the protocol), and T3 (post-exercise, minute 125 of the protocol).
|
|
Heart Rate Recovery (bpm)
Ramy czasowe: Measured continuously during the first 5 minutes immediately following exercise cessation.
|
Heart rate recorded during the post-exercise recovery period, expressed in beats per minute (bpm).
|
Measured continuously during the first 5 minutes immediately following exercise cessation.
|
|
Rating of Perceived Exertion (Borg Scale, points)
Ramy czasowe: Before and immediately after warm-up, immediately after the Anaerobic Threshold phase, immediately after the Self-paced Maximal Time-trial, and immediately after cooldown during each laboratory study visit.
|
Perceived exertion will be assessed using the Borg Rating of Perceived Exertion Scale and reported in points (6-20).
|
Before and immediately after warm-up, immediately after the Anaerobic Threshold phase, immediately after the Self-paced Maximal Time-trial, and immediately after cooldown during each laboratory study visit.
|
|
Personality Traits (NEO-FFI, points)
Ramy czasowe: Measured at baseline (first study visit).
|
Personality traits will be assessed using the NEO Five-Factor Inventory (NEO-FFI).
The questionnaire provides scores for five personality domains: Neuroticism, Extraversion, Openness to Experience, Agreeableness, and Conscientiousness.
Results will be reported as domain scores in points.
|
Measured at baseline (first study visit).
|
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Mood State (POMS/BRUMS) (points)
Ramy czasowe: Measured during each laboratory study visit.
|
Mood state assessed using the Profile of Mood States (POMS/BRUMS), expressed in points.
|
Measured during each laboratory study visit.
|
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Caffeine Expectancy (Caff-EQ-Brief) (points)
Ramy czasowe: Measured 30 minutes post-ingestion.
|
Caffeine expectancy assessed using the Caffeine Expectancy Questionnaire-Brief (Caff-EQ-Brief), expressed in points.
|
Measured 30 minutes post-ingestion.
|
|
Urine pH
Ramy czasowe: Measured once prior to the start of each laboratory study visit.
|
Urine pH measured using a urine strip analyzer.
|
Measured once prior to the start of each laboratory study visit.
|
|
White blood cells count and differential (count/L)
Ramy czasowe: Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
Assessment of the hematological parameter will be performed from fingertip capillary blood collected before supplementation (baseline), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
|
White blood cells count and differential (%)
Ramy czasowe: Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
Assessment of the hematological parameter will be performed from fingertip capillary blood collected before supplementation (baseline), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
|
Hematological indices (red blood cells, RBC) (count/L)
Ramy czasowe: Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
Assessment of the hematological parameter will be performed from fingertip capillary blood collected before supplementation (baseline), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
|
Hematological indices (hemoglobin concentration, HGB) (mmol/L)
Ramy czasowe: Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
Assessment of the hematological parameter will be performed from fingertip capillary blood collected before supplementation (baseline), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
|
Hematological indices (hematocrit, HCT) (L/L)
Ramy czasowe: Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
Assessment of the hematological parameter will be performed from fingertip capillary blood collected before supplementation (baseline), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
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Hematological indices (mean corpuscular volume, MCV; mean platelet volume, MPV) (fL)
Ramy czasowe: Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
Assessment of the hematological parameter will be performed from fingertip capillary blood collected before supplementation (baseline), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
|
Hematological indices (mean corpuscular hemoglobin mass, MCH) (fmol)
Ramy czasowe: Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
Assessment of the hematological parameter will be performed from fingertip capillary blood collected before supplementation (baseline), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
|
Hematological indices (mean corpuscular hemoglobin concentration, MCHC) (mmol/L)
Ramy czasowe: Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
Assessment of the hematological parameter will be performed from fingertip capillary blood collected before supplementation (baseline), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
|
Hematological indices (platelet count, PLT) (count/L)
Ramy czasowe: Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
Assessment of the hematological parameter will be performed from fingertip capillary blood collected before supplementation (baseline), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
|
Hematological indices (platelet hematocrit, PCT) (cL/L)
Ramy czasowe: Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
Assessment of the hematological parameter will be performed from fingertip capillary blood collected before supplementation (baseline), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
|
Hematological indices (platelet distribution width, PDW; platelet large cell ratio, PLCR; red blood cells distribution width - coefficient of variation, RDW-C) (%)
Ramy czasowe: Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
Assessment of the hematological parameter will be performed from fingertip capillary blood collected before supplementation (baseline), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
|
Hematological indices (red blood cells distribution width - standard deviation, RDW-S) (fL)
Ramy czasowe: Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
Assessment of the hematological parameter will be performed from fingertip capillary blood collected before supplementation (baseline), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
|
Urea Concentration (mmol/L)
Ramy czasowe: Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
Urea concentration measured from fingertip capillary blood and expressed in mmol/L.
|
Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
|
Glucose Concentration (mg/dL)
Ramy czasowe: Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
Glucose concentration measured from fingertip capillary blood and expressed in mg/dL.
|
Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
|
Creatinine concentration (μmol/L)
Ramy czasowe: Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
Creatinine concentration measured from fingertip capillary blood and expressed in µmol/L.
|
Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
|
Muscle damage markers (activity of alanine aminotransferase, aspartate aminotransferase, creatine kinase, lactate dehydrogenase) (U/L)
Ramy czasowe: Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
Assessment of the muscle damage markers (activity of alanine aminotransferase, aspartate aminotransferase, creatine kinase, lactate dehydrogenase) (U/L) will be performed from fingertip capillary blood.
|
Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
|
Lactate concentration (mmol/L)
Ramy czasowe: Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
Blood lactate concentration measured from fingertip capillary blood and expressed in mmol/L.
|
Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
|
Electrolites' concentration (Ca, Na, K, Cl) (mmol/L)
Ramy czasowe: Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
Assessment of electrolites' concentration (Ca, Na, K, Cl) (mmol/L) will be performed from fingertip capillary blood.
|
Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
|
Blood pH
Ramy czasowe: Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
Assessment of gasometry markers (blood pH) will be performed from fingertip capillary blood.
|
Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
|
Partial Pressure of Carbon Dioxide and Oxygen (pCO2, pO2) (mmHg)
Ramy czasowe: Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
Assessment of gasometry markers (pCO2, pO2) (mmHg) will be performed from fingertip capillary blood.
|
Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
|
CAF and PAX concentrations (µmol/L)
Ramy czasowe: Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
Assessment of caffeine and paraxanthine concentrations (µmol/L) will be performed from fingertip capillary blood.
|
Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before exercise, and 3 minutes post-exercise.
|
|
Static weight distribution (mm)
Ramy czasowe: Measured at the start of each study visit.
|
Static weight distribution expressed in millimeters of Center of Pressure symmetry.
|
Measured at the start of each study visit.
|
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Analysis of body composition (fat-free mass, fat mass) (kg)
Ramy czasowe: Measured at the start of each study visit.
|
Assessment of body composition (fat-free mass, fat mass) (kg) will be carried out at the start of each study visit.
|
Measured at the start of each study visit.
|
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Analysis of body composition (total body water) (L)
Ramy czasowe: Measured at the start of each study visit.
|
Assessment of body composition (total body water) (L) will be carried out at the start of each study visit.
|
Measured at the start of each study visit.
|
|
Analysis of body composition (total body water) (%)
Ramy czasowe: Measured at the start of each study visit.
|
Assessment of body composition (total body water) (%) will be carried out at the start of each study visit.
|
Measured at the start of each study visit.
|
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Autonomic Response during Cognitive Performance (bpm)
Ramy czasowe: Measured at three time points: T1 (pre-ingestion; 2 minute of protocol), T2 (post-ingestion/pre-exercise; 55 minute of protocol), and T3 (post-exercise; 125 minute of protocol).
|
Heart rate and heart rate variability recording during cognitive testing blocks, expressed in beats per minute (bpm).
|
Measured at three time points: T1 (pre-ingestion; 2 minute of protocol), T2 (post-ingestion/pre-exercise; 55 minute of protocol), and T3 (post-exercise; 125 minute of protocol).
|
|
Anthropometric Indices (kg)
Ramy czasowe: Measured at the start of each study visit.
|
Body mass in kilograms will be measured at the start of each study visit.
|
Measured at the start of each study visit.
|
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Anthropometric Indices (metres)
Ramy czasowe: Measured at the start of each study visit.
|
Height in metres will be measured at the start of each study visit.
|
Measured at the start of each study visit.
|
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Explosive power variables (ms)
Ramy czasowe: Continuous recording throughout the exercise protocol and discrete assessments at T1 (2 minute of protocol), T2 (55 minute of protocol), and T3 (125 minute of protocol).
|
Explosive lower-limb power variables expressed in milliseconds (ms) - Countermovement Jump - contact time and flight time.
|
Continuous recording throughout the exercise protocol and discrete assessments at T1 (2 minute of protocol), T2 (55 minute of protocol), and T3 (125 minute of protocol).
|
|
Explosive power variables (W)
Ramy czasowe: Continuous recording throughout the exercise protocol and discrete assessments at T1 (2 minute of protocol), T2 (55 minute of protocol), and T3 (125 minute of protocol).
|
Explosive lower-limb power expressed in Watts (W) - Countermovement Jump - power.
|
Continuous recording throughout the exercise protocol and discrete assessments at T1 (2 minute of protocol), T2 (55 minute of protocol), and T3 (125 minute of protocol).
|
|
Hydration Status (g/mL)
Ramy czasowe: Once prior to the start of each laboratory study visit.
|
Assessment of urine specific gravity (g/mL) using a urine strip analyzer.
|
Once prior to the start of each laboratory study visit.
|
|
Flanker Test Accuracy (%)
Ramy czasowe: Measured at T1 (pre-ingestion, minute 2 of the protocol), T2 (post-ingestion/pre-exercise, minute 55 of the protocol), and T3 (post-exercise, minute 125 of the protocol).
|
Accuracy during the Flanker Test expressed as the percentage of correct responses.
|
Measured at T1 (pre-ingestion, minute 2 of the protocol), T2 (post-ingestion/pre-exercise, minute 55 of the protocol), and T3 (post-exercise, minute 125 of the protocol).
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Heart Rate Variability Recovery (ms)
Ramy czasowe: Measured continuously during the first 5 minutes immediately following exercise cessation.
|
Heart rate variability expressed in milliseconds (ms) during the post-exercise recovery period.
|
Measured continuously during the first 5 minutes immediately following exercise cessation.
|
|
Caffeine Expectancy Questionnaire Score (points)
Ramy czasowe: Measured 30 minutes post-ingestion.
|
Caffeine expectancy assessed using the Caffeine Expectancy Questionnaire and expressed in points.
|
Measured 30 minutes post-ingestion.
|
|
Suggestibility (SSS) (points)
Ramy czasowe: Measured during the last study visit.
|
General suggestibility assessed using the Short Suggestibility Scale (SSS), expressed in points.
|
Measured during the last study visit.
|
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Intrinsic Motivation (IMI) (points)
Ramy czasowe: Measured after each test block during every laboratory study visit.
|
Task-specific intrinsic motivation assessed using the Intrinsic Motivation Inventory (IMI), expressed in points.
|
Measured after each test block during every laboratory study visit.
|
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Sport Motivation (SMS) (points)
Ramy czasowe: Measured during the first study visit.
|
Sport motivation assessed using the Sport Motivation Scale (SMS), expressed in points.
|
Measured during the first study visit.
|
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Sleep Quality (LSEQ) (points)
Ramy czasowe: Measured once during each laboratory study visit.
|
Subjective sleep quality assessed using the Leeds Sleep Evaluation Questionnaire (LSEQ), expressed in points.
|
Measured once during each laboratory study visit.
|
|
Salivary Cortisol Concentration (nmol/L)
Ramy czasowe: Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before warm-up (60 minutes post-ingestion), 3 minutes post-exercise, and 10 minutes post-exercise.
|
Salivary cortisol concentration expressed in nmol/L.
|
Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before warm-up (60 minutes post-ingestion), 3 minutes post-exercise, and 10 minutes post-exercise.
|
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Salivary Testosterone Concentration (pmol/L)
Ramy czasowe: Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before warm-up (60 minutes post-ingestion), 3 minutes post-exercise, and 10 minutes post-exercise.
|
Salivary testosterone concentration expressed in pmol/L.
|
Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before warm-up (60 minutes post-ingestion), 3 minutes post-exercise, and 10 minutes post-exercise.
|
|
Salivary Alpha-amylase Activity (U/L)
Ramy czasowe: Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before warm-up (60 minutes post-ingestion), 3 minutes post-exercise, and 10 minutes post-exercise.
|
Salivary alpha-amylase activity expressed in U/L.
|
Measured at baseline (pre-supplementation), 30 minutes post-ingestion, before warm-up (60 minutes post-ingestion), 3 minutes post-exercise, and 10 minutes post-exercise.
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Śledczy
- Główny śledczy: Jakub Malik, PhD, Poznan University of Physical Education, Department of Sports Psychology
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
1 stycznia 2027
Zakończenie podstawowe (Szacowany)
31 marca 2028
Ukończenie studiów (Szacowany)
31 marca 2029
Daty rejestracji na studia
Pierwszy przesłany
21 lipca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
31 lipca 2026
Pierwszy wysłany (Rzeczywisty)
5 sierpnia 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
18 września 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
15 września 2026
Ostatnia weryfikacja
1 lipca 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 152-2-26
- 2025/57/N/NZ4/04470 (Inny numer grantu/finansowania: National Science Centre)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu IPD
The study protocol will be published as an open-access article.
Upon completion of the study, de-identified individual participant data (IPD) and relevant analytic code will be deposited in an open-access repository such as Zenodo or OSF, following the FAIR principles.
Ramy czasowe udostępniania IPD
The study protocol will be available upon its publication.
The IPD and analytic code will be available starting from the date of the primary study results publication and will remain accessible for at least 5 years.
Kryteria dostępu do udostępniania IPD
The study protocol will be published as an open-access article.
Upon completion of the study, de-identified individual participant data (IPD) and relevant analytic code will be deposited in an open-access repository such as Zenodo or OSF, in accordance with FAIR principles.
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .