Physical PerformanceNCT07742150
Placebo Effect in Field-Based Physical Performance
A study testing Caffeine (6mg/kg) in people with Physical Performance and Placebo Effect, run by Poznan University of Physical Education at 1 site in Poland.
Trial summary
This study aims to investigate the placebo (PLA) effect on physical performance across different sports disciplines in real-world, field-based settings. The study investigates how participant expectations and beliefs regarding caffeine (CAF) intake influence physical performance and psychomotor function outside the… Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Performance, Placebo Effect, Cognitive Performance
- What is being tested?
- Caffeine (6mg/kg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 sitePoland
- Study dates
- 1 Sep 2026to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 20 and 35 years,
- Healthy adults,
- Regular physical activity,
- Normal or corrected-to-normal vision,
- Habitual caffeine consumption.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site
Poznan University of Physical Education
Poznan, Greater Poland Voivodeship
Jakub Malik, PhD, +48739975701, malik@awf.poznan.pl
About this study
Official title: Psychophysiological Mechanisms of the Placebo Effect on Physical Performance in Field Settings
This study aims to investigate the placebo (PLA) effect on physical performance across different sports disciplines in real-world, field-based settings. The study investigates how participant expectations and beliefs regarding caffeine (CAF) intake influence physical performance and psychomotor function outside the controlled laboratory environment. Healthy, physically active adults (n = 120) from diverse sports backgrounds will be randomly assigned to receive caffeine, placebo, or no intervention. Participants will perform discipline-specific field exercise tests (e.g., running-based protocols or repeated sprint protocols) while physiological responses are monitored using wearable technology. Physical performance outcomes and psychomotor responses will be analyzed to evaluate the real-world impact of the placebo effect and to distinguish the pharmacological effects of caffeine from those driven by psychological expectations across different athletic settings.
Read the detailed description
This study employs a cross-sectional design conducted in diverse field settings to investigate the placebo (PLA) effect across different sports disciplines. Participants (n = 120, aged 20-35 years) representing different training profiles (endurance and mixed) will be randomly assigned to one of three parallel groups: Caffeine, Placebo, or Control. Each participant will complete a single experimental session lasting approximately 35 minutes, consisting of: (1) baseline psychomotor assessment using the Simple Reaction Time test, (2) a discipline-specific exercise protocol (e.g., the Cooper test performed on an athletics track or a Repeated Sprint Ability protocol), and (3) post-exercise recovery monitoring. Physiological parameters, including heart rate (HR), heart rate variability (HRV), and respiratory rate (RR), together with postural stability, will be continuously monitored using wearable technology. The study will evaluate how psychological expectations influence physical performance, psychomotor function, and physiological responses during sport-specific exercise, providing evidence for the role of the placebo effect under real-world athletic conditions.
- Conditions
- Physical Performance, Placebo Effect, Cognitive Performance
- Being tested
- Caffeine (6mg/kg), Placebo (Starch capsule), Sham (No Treatment)
- Keywords
- Caffeine, Expectancy, Psychophysiology, Exercise Physiology, Postural Control, Human Performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeine (6mg/kg)Drug
Anhydrous caffeine administered in an encapsulated form at a dosage of 6mg per kilogram of body mass, 30-60 minutes before the exercise protocol.
Placebo (Starch capsule)Other
Corn starch administered in an identical encapsulated form as the active caffeine, 30-60 minutes before the exercise protocol.
Sham (No Treatment)Other
Participants perform the same exercise protocols without any capsule or substance administration.
| Study group | Role | What they receive |
|---|---|---|
| Caffeine Group | Experimental | Participants ingest a single dose of caffeine (6mg/kg body mass) prior to a field-based exercise protocol (e.g., Cooper test or Repeated Sprint Ability). Receives: Drug: Caffeine (6mg/kg) |
| Placebo Group | Active comparator | Participants ingest a single dose of placebo (corn starch) in an identical capsule prior to a field-based exercise protocol. Receives: Other: Placebo (Starch capsule) |
| Control Group | Sham comparator | Participants perform the same field-based exercise protocol without ingesting any capsule or active substance. Receives: Other: Sham (No Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Performance Capacity (total distance in running, metres)
Total physical work capacity measured as the total running distance (metres) completed during the standardized exercise protocol.
Measured: Measured during the exercise protocol immediately following administration of the study intervention.
Physical Performance Capacity (total work in Joules for cycling)
Total physical work capacity measured as the total mechanical work (Joules) completed during the standardized cycling exercise protocol.
Measured: Measured during the exercise protocol immediately following administration of the study intervention.
Physical Performance Capacity (exercise duration until exhaustion, minutes)
Total physical work capacity measured as exercise duration until volitional exhaustion during the standardized exercise protocol.
Measured: Measured during the exercise protocol immediately following administration of the study intervention.
Secondary outcomes (19)
Exercise Heart Rate (bpm)
Heart rate (beats per minute) recorded continuously throughout the standardized exercise protocol.
Measured: Continuously monitored during the exercise protocol immediately following administration of the study intervention.
Cognitive Heart Rate (bpm)
Heart rate recorded during standardized cognitive performance tasks.
Measured: Measured during cognitive testing immediately before and immediately after the exercise protocol.
Post-Exercise Heart Rate Recovery (bpm)
Heart rate recorded during the post-exercise recovery period.
Measured: Continuously monitored during the first 5 minutes immediately following completion of the exercise protocol.
Cognitive Reaction Time (ms)
Reaction time measured during standardized cognitive tasks (e.g., Psychomotor Vigilance Test, Stroop Test, Flanker Test).
Measured: Measured immediately before and immediately after the exercise protocol.
Rating of Perceived Exertion (Borg Scale, points)
Perceived exertion assessed using the Borg Rating of Perceived Exertion Scale (6-20).
Measured: Measured immediately after completion of the exercise protocol.
Biomechanical Kinematic Profile (cm)
Continuous recording of kinematic parameters derived from wearable sensors, including step length and vertical oscillation.
Measured: Continuously monitored during the exercise protocol immediately following administration of the study intervention.
Biomechanical Kinematic Profile (ms)
Continuous recording of stance time derived from wearable sensor data.
Measured: Continuously monitored during the exercise protocol immediately following administration of the study intervention.
Biomechanical Kinematic Profile (steps/min)
Continuous recording of cadence derived from wearable sensor data.
Measured: Continuously monitored during the exercise protocol immediately following administration of the study intervention.
Anthropometric Indices (kg)
Body mass expressed in kilograms.
Measured: Measured at the start of the protocol.
Anthropometric Indices (m)
Height expressed in metres.
Measured: Measured at the start of the protocol.
Body composition (fat-free mass, fat mass) (kg)
Assessment of body composition (fat-free mass, fat mass) (kg) will be performed at the start of the protocol.
Measured: Measured at the start of the protocol.
Body composition (fat-free mass, fat mass) (%)
Assessment of body composition (fat-free mass, fat mass) (%) will be performed at the start of the protocol.
Measured: Measured at the start of the protocol.
Body composition (total body water) (L)
Assessment of body composition (total body water) (L) will be performed at baseline at the start of the protocol.
Measured: Measured at the start of the protocol.
Body composition (total body water) (%)
Assessment of body composition (total body water) (%) will be performed at baseline at the start of the protocol.
Measured: Measured at the start of the protocol.
Exercise Heart Rate Variability (ms)
Heart rate variability recorded continuously throughout the standardized exercise protocol to assess autonomic regulation.
Measured: Continuously monitored during the exercise protocol immediately following administration of the study intervention.
Cognitive Heart Rate Variability (ms)
Heart rate variability recorded during standardized cognitive performance tasks.
Measured: Measured during cognitive testing immediately before and immediately after the exercise protocol.
Post-Exercise Heart Rate Variability Recovery (ms)
Heart rate variability recorded during the post-exercise recovery period.
Measured: Continuously monitored during the first 5 minutes immediately following completion of the exercise protocol.
Cognitive Accuracy (%)
Accuracy measured during standardized cognitive tasks (e.g., Psychomotor Vigilance Test, Stroop Test, Flanker Test).
Measured: Measured immediately before and immediately after the exercise protocol.
Performance Expectancy (points)
Measured immediately before the exercise protocol following administration of the study intervention.
Measured: Measured immediately after completion of the exercise protocol.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical PerformanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of three parallel groups: Caffeine, Placebo, or Control, with a single testing visit per participant.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jakub Malik, PhD, Principal investigator, Poznan University of Physical Education, Department of Sports Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742150
- Sponsor's protocol ID
- 152-1-26
- Other IDs
- 2025/57/N/NZ4/04470
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision regarding the sharing of individual participant data has not yet been finalized. We are currently evaluating the feasibility, ethical considerations, and data privacy requirements for potential data sharing. A formal plan will be developed and implemented in accordance with institutional policies and regulatory standards upon the completion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychophysiological Mechanisms of the Placebo Effect on Physical Performance in Field Settings
- ClinicalTrials.gov ID
- NCT07742150
- Acronym / sponsor ID
- 152-1-26
- Conditions
- Physical Performance, Placebo Effect, Cognitive Performance
- Keywords
- Caffeine, Expectancy, Psychophysiology, Exercise Physiology, Postural Control, Human Performance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the placebo (PLA) effect on physical performance across different sports disciplines in real-world, field-based settings. The study investigates how participant expectations and beliefs regarding caffeine (CAF) intake influence physical performance and psychomotor function outside the controlled laboratory environment. Healthy, physically active adults (n = 120) from diverse sports backgrounds will be randomly assigned to receive caffeine, placebo, or no intervention. Participants will perform discipline-specific field exercise tests (e.g., running-based protocols or repeated sprint protocols) while physiological responses are monitored using wearable technology. Physical performance outcomes and psychomotor responses will be analyzed to evaluate the real-world impact of the placebo effect and to distinguish the pharmacological effects of caffeine from those driven by psychological expectations across different athletic settings.
Detailed description
This study employs a cross-sectional design conducted in diverse field settings to investigate the placebo (PLA) effect across different sports disciplines. Participants (n = 120, aged 20-35 years) representing different training profiles (endurance and mixed) will be randomly assigned to one of three parallel groups: Caffeine, Placebo, or Control. Each participant will complete a single experimental session lasting approximately 35 minutes, consisting of: (1) baseline psychomotor assessment using the Simple Reaction Time test, (2) a discipline-specific exercise protocol (e.g., the Cooper test performed on an athletics track or a Repeated Sprint Ability protocol), and (3) post-exercise recovery monitoring. Physiological parameters, including heart rate (HR), heart rate variability (HRV), and respiratory rate (RR), together with postural stability, will be continuously monitored using wearable technology. The study will evaluate how psychological expectations influence physical performance, psychomotor function, and physiological responses during sport-specific exercise, providing evidence for the role of the placebo effect under real-world athletic conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants are randomly assigned to one of three parallel groups: Caffeine, Placebo, or Control, with a single testing visit per participant.
| Arm | Type | Receives |
|---|---|---|
| Caffeine Group | Experimental | Drug: Caffeine (6mg/kg)Participants ingest a single dose of caffeine (6mg/kg body mass) prior to a field-based exercise protocol (e.g., Cooper test or Repeated Sprint Ability). |
| Placebo Group | Active comparator | Other: Placebo (Starch capsule)Participants ingest a single dose of placebo (corn starch) in an identical capsule prior to a field-based exercise protocol. |
| Control Group | Sham comparator | Other: Sham (No Treatment)Participants perform the same field-based exercise protocol without ingesting any capsule or active substance. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 20 and 35 years,
- Healthy adults,
- Regular physical activity,
- Normal or corrected-to-normal vision,
- Habitual caffeine consumption.
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caffeine (6mg/kg)Anhydrous caffeine administered in an encapsulated form at a dosage of 6mg per kilogram of body mass, 30-60 minutes before the exercise protocol. | Drug | Caffeine Group |
| Placebo (Starch capsule)Corn starch administered in an identical encapsulated form as the active caffeine, 30-60 minutes before the exercise protocol. | Other | Placebo Group |
| Sham (No Treatment)Participants perform the same exercise protocols without any capsule or substance administration. | Other | Control Group |
Primary outcome
Physical Performance Capacity (total distance in running, metres)
Time frame: Measured during the exercise protocol immediately following administration of the study intervention.
Total physical work capacity measured as the total running distance (metres) completed during the standardized exercise protocol.
Physical Performance Capacity (total work in Joules for cycling)
Time frame: Measured during the exercise protocol immediately following administration of the study intervention.
Total physical work capacity measured as the total mechanical work (Joules) completed during the standardized cycling exercise protocol.
Physical Performance Capacity (exercise duration until exhaustion, minutes)
Time frame: Measured during the exercise protocol immediately following administration of the study intervention.
Total physical work capacity measured as exercise duration until volitional exhaustion during the standardized exercise protocol.
19 secondary outcomes
Exercise Heart Rate (bpm)
Time frame: Continuously monitored during the exercise protocol immediately following administration of the study intervention.
Cognitive Heart Rate (bpm)
Time frame: Measured during cognitive testing immediately before and immediately after the exercise protocol.
Post-Exercise Heart Rate Recovery (bpm)
Time frame: Continuously monitored during the first 5 minutes immediately following completion of the exercise protocol.
Cognitive Reaction Time (ms)
Time frame: Measured immediately before and immediately after the exercise protocol.
Rating of Perceived Exertion (Borg Scale, points)
Time frame: Measured immediately after completion of the exercise protocol.
Biomechanical Kinematic Profile (cm)
Time frame: Continuously monitored during the exercise protocol immediately following administration of the study intervention.
Biomechanical Kinematic Profile (ms)
Time frame: Continuously monitored during the exercise protocol immediately following administration of the study intervention.
Biomechanical Kinematic Profile (steps/min)
Time frame: Continuously monitored during the exercise protocol immediately following administration of the study intervention.
Anthropometric Indices (kg)
Time frame: Measured at the start of the protocol.
Anthropometric Indices (m)
Time frame: Measured at the start of the protocol.
Body composition (fat-free mass, fat mass) (kg)
Time frame: Measured at the start of the protocol.
Body composition (fat-free mass, fat mass) (%)
Time frame: Measured at the start of the protocol.
Body composition (total body water) (L)
Time frame: Measured at the start of the protocol.
Body composition (total body water) (%)
Time frame: Measured at the start of the protocol.
Exercise Heart Rate Variability (ms)
Time frame: Continuously monitored during the exercise protocol immediately following administration of the study intervention.
Cognitive Heart Rate Variability (ms)
Time frame: Measured during cognitive testing immediately before and immediately after the exercise protocol.
Post-Exercise Heart Rate Variability Recovery (ms)
Time frame: Continuously monitored during the first 5 minutes immediately following completion of the exercise protocol.
Cognitive Accuracy (%)
Time frame: Measured immediately before and immediately after the exercise protocol.
Performance Expectancy (points)
Time frame: Measured immediately after completion of the exercise protocol.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: Undecided. The decision regarding the sharing of individual participant data has not yet been finalized. We are currently evaluating the feasibility, ethical considerations, and data privacy requirements for potential data sharing. A formal plan will be developed and implemented in accordance with institutional policies and regulatory standards upon the completion of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jakub Malik, PhD principal investigator
Poznan University of Physical Education, Department of Sports Psychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeine (6mg/kg) in people with Physical Performance and Placebo Effect, run by Poznan University of Physical Education at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jakub Malik, PhD (+48739975701, malik@awf.poznan.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Performance Capacity (total distance in running, metres) (time frame: Measured during the exercise protocol immediately following administration of the study intervention.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.