Athletic PerformanceNCT07254832
Effects of Caffeine and Nicotine Gum on Balance Performance in Athletes
A study testing Caffeine Gum 3mg/kg and Nicotine Gum (4 mg) in people with Athletic Performance and Postural Stability, run by Gülbin Rudarlı at 1 site in Turkey (Türkiye).
Trial summary
This randomized, single-blind, placebo-controlled, four-condition crossover study evaluates the acute effects of caffeine gum (~3 mg/kg) and nicotine gum (4 mg) on balance performance in healthy, trained adults. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Athletic Performance, Postural Stability, Healhty
- What is being tested?
- Caffeine Gum 3mg/kg and Nicotine Gum (4 mg)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jan 2024to 2 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be healthy, with no diagnosed neurological or musculoskeletal disorders
- Be physically active and have at least 3 years of regular training history
- Be between 18 and 30 years of age
- Have no balance impairments or vestibular issues
- Be non-smoker or not using tobacco during study days
- Able to comply with the intervention protocols and attend all test sessions
- Provide written informed consent
Who cannot join
- Training age less than three years,
- Having a disease or sports injury that will affect balance performance,
- Using a drug or substance that affects balance,
- Not being able to comply with or continue the study measurements.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University, Faculty of Sport Sciences
Izmir
About this study
Official title: No Significant Alterations in Balance Performance After Acute Caffeine and Nicotine Gum Intake in Trained Athletes
This randomized, single-blind, placebo-controlled, four-condition crossover study evaluates the acute effects of caffeine gum (~3 mg/kg) and nicotine gum (4 mg) on balance performance in healthy, trained adults. Each participant completes four test visits (caffeine gum, nicotine gum, xylitol-based placebo gum, and no-gum control) separated by ≥24 hours. Static and dynamic balance are assessed using the ProKin 252 system under standardized procedures. The primary outcomes are postural sway (ellipse area) and center-of-pressure path length over predefined test trials/time frames. The objective is to determine whether acute administration of these stimulants alters balance-related performance relative to placebo and control.
Read the detailed description
This study evaluates the acute effects of two commonly used stimulants-caffeine and nicotine administered in chewing-gum form-on static and dynamic balance performance in healthy, trained adults. The trial uses a randomized, single-blind, placebo-controlled, four-condition crossover design. Twenty participants complete four laboratory visits scheduled at the same time of day and separated by a washout interval of at least 24 hours. The order of the four conditions is randomized.
Interventions are: (1) caffeine gum at approximately 3 mg/kg, (2) nicotine gum at 4 mg, (3) sugar-free xylitol-based placebo gum, and (4) a no-gum control condition. Pre-testing exposure is standardized across conditions: caffeine gum is chewed for 5 minutes, nicotine gum for 30 minutes, and placebo gum for 20 minutes prior to balance assessments. The control condition involves no gum exposure. All procedures are conducted under uniform laboratory conditions.
Balance performance is assessed immediately after the pre-specified exposure period using the ProKin 252 balance platform. Standardized static and dynamic balance tasks are administered according to device guidelines and site procedures. Primary outcomes are postural sway quantified as ellipse area and center-of-pressure path length over predefined trials/time frames. Additional procedural details (e.g., task sequence, rest intervals, and device settings) are maintained in the study manual to ensure consistency across visits.
The objective is to determine whether acute administration of caffeine or nicotine, relative to placebo and control, alters balance-related performance indices in healthy, physically active individuals.
- Conditions
- Athletic Performance, Postural Stability, Healhty
- Being tested
- Caffeine Gum 3mg/kg, Nicotine Gum (4 mg), Placebo Gum (Xylitol)
- Keywords
- Caffeinated chewing gum, Nicotine chewing gum, Caffeine, Nicotine, Dynamic balance, Postural control, Ellipse area, Perimeter length, Trained athletes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeine Gum 3mg/kgDietary supplement
Participants chewed 2-3 pieces of 100 mg caffeine gum (~3 mg/kg total) for 5 minutes prior to balance testing.
Nicotine Gum (4 mg)Dietary supplement
Participants chewed one piece of 4 mg nicotine gum for 30 minutes before undergoing balance testing.
Placebo Gum (Xylitol)Other
Participants chewed xylitol-based sugar-free gum with no active substance for 20 minutes prior to testing.
| Study group | Role | What they receive |
|---|---|---|
| caffeine gum | Experimental | Not described Receives: Dietary Supplement: Caffeine Gum 3mg/kg |
| Nicotine Gum | Active comparator | Not described Receives: Dietary Supplement: Nicotine Gum (4 mg) |
| Placebo Gum | Placebo comparator | Not described Receives: Other: Placebo Gum (Xylitol) |
| Control | No intervention | No chewing gum administered; participants completed balance testing without any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static Postural Sway Ellipse Area - ProKin 252 Stabilometric Platform
Center of pressure (COP) 95% ellipse area during quiet bipedal stance (eyes open; standardized foot position) measured with the ProKin 252. Higher values indicate poorer balance.
Unit of Measure: mm^2
Measured: At each visit: 5 minutes after start of chewing (caffeine gum), 30 minutes after start of chewing (nicotine gum), 20 minutes after start of chewing (xylitol placebo gum), and 0 minutes (no gum) for the control condition; single 30-second trial per visit
Secondary outcomes (1)
Static Center of Pressure (COP) Path Length - ProKin 252 Stabilometric Platform
Total COP excursion length during quiet bipedal stance (eyes open; standardized foot position) measured with the ProKin 252. Higher values indicate poorer balance.
Unit of Measure: mm
Measured: At each visit: 5 minutes after start of chewing (caffeine gum), 30 minutes after start of chewing (nicotine gum), 20 minutes after start of chewing (xylitol placebo gum), and 0 minutes (no gum) for the control condition; single 30-second trial per visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start8 Jan 2024
- Primary completion5 Apr 2024
- Study completion2 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Athletic 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gülbin Rudarlı
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gülbin Rudarlı, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254832
- Sponsor's protocol ID
- EGE-24-3.1T-81
- Status last verified
- Nov 2025
- First submitted
- 8 Jul 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- No Significant Alterations in Balance Performance After Acute Caffeine and Nicotine Gum Intake in Trained Athletes
- ClinicalTrials.gov ID
- NCT07254832
- Acronym / sponsor ID
- EGE-24-3.1T-81
- Conditions
- Athletic Performance, Postural Stability, Healhty
- Keywords
- Caffeinated chewing gum, Nicotine chewing gum, Caffeine, Nicotine, Dynamic balance, Postural control, Ellipse area, Perimeter length
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Gülbin RudarlıUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 5 Apr 2024 (actual)
- Study completion
- 2 Jul 2024 (actual)
- First posted
- 28 Nov 2025 (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 randomized, single-blind, placebo-controlled, four-condition crossover study evaluates the acute effects of caffeine gum (~3 mg/kg) and nicotine gum (4 mg) on balance performance in healthy, trained adults. Each participant completes four test visits (caffeine gum, nicotine gum, xylitol-based placebo gum, and no-gum control) separated by ≥24 hours. Static and dynamic balance are assessed using the ProKin 252 system under standardized procedures. The primary outcomes are postural sway (ellipse area) and center-of-pressure path length over predefined test trials/time frames. The objective is to determine whether acute administration of these stimulants alters balance-related performance relative to placebo and control.
Detailed description
This study evaluates the acute effects of two commonly used stimulants-caffeine and nicotine administered in chewing-gum form-on static and dynamic balance performance in healthy, trained adults. The trial uses a randomized, single-blind, placebo-controlled, four-condition crossover design. Twenty participants complete four laboratory visits scheduled at the same time of day and separated by a washout interval of at least 24 hours. The order of the four conditions is randomized.
Interventions are: (1) caffeine gum at approximately 3 mg/kg, (2) nicotine gum at 4 mg, (3) sugar-free xylitol-based placebo gum, and (4) a no-gum control condition. Pre-testing exposure is standardized across conditions: caffeine gum is chewed for 5 minutes, nicotine gum for 30 minutes, and placebo gum for 20 minutes prior to balance assessments. The control condition involves no gum exposure. All procedures are conducted under uniform laboratory conditions.
Balance performance is assessed immediately after the pre-specified exposure period using the ProKin 252 balance platform. Standardized static and dynamic balance tasks are administered according to device guidelines and site procedures. Primary outcomes are postural sway quantified as ellipse area and center-of-pressure path length over predefined trials/time frames. Additional procedural details (e.g., task sequence, rest intervals, and device settings) are maintained in the study manual to ensure consistency across visits.
The objective is to determine whether acute administration of caffeine or nicotine, relative to placebo and control, alters balance-related performance indices in healthy, physically active individuals.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| caffeine gum | Experimental | Dietary Supplement: Caffeine Gum 3mg/kg |
| Nicotine Gum | Active comparator | Dietary Supplement: Nicotine Gum (4 mg) |
| Placebo Gum | Placebo comparator | Other: Placebo Gum (Xylitol) |
| Control | No intervention | –No chewing gum administered; participants completed balance testing without any intervention. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Be healthy, with no diagnosed neurological or musculoskeletal disorders
- Be physically active and have at least 3 years of regular training history
- Be between 18 and 30 years of age
- Have no balance impairments or vestibular issues
- Be non-smoker or not using tobacco during study days
Key exclusion criteria (4 listed)
- Training age less than three years,
- Having a disease or sports injury that will affect balance performance,
- Using a drug or substance that affects balance,
- Not being able to comply with or continue the study measurements.
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 Gum 3mg/kgParticipants chewed 2-3 pieces of 100 mg caffeine gum (~3 mg/kg total) for 5 minutes prior to balance testing. | Dietary supplement | caffeine gum |
| Nicotine Gum (4 mg)Participants chewed one piece of 4 mg nicotine gum for 30 minutes before undergoing balance testing. | Dietary supplement | Nicotine Gum |
| Placebo Gum (Xylitol)Participants chewed xylitol-based sugar-free gum with no active substance for 20 minutes prior to testing. | Other | Placebo Gum |
Primary outcome
Static Postural Sway Ellipse Area - ProKin 252 Stabilometric Platform
Time frame: At each visit: 5 minutes after start of chewing (caffeine gum), 30 minutes after start of chewing (nicotine gum), 20 minutes after start of chewing (xylitol placebo gum), and 0 minutes (no gum) for the control condition; single 30-second trial per visit
Center of pressure (COP) 95% ellipse area during quiet bipedal stance (eyes open; standardized foot position) measured with the ProKin 252. Higher values indicate poorer balance. Unit of Measure: mm^2
1 secondary outcome
Static Center of Pressure (COP) Path Length - ProKin 252 Stabilometric Platform
Time frame: At each visit: 5 minutes after start of chewing (caffeine gum), 30 minutes after start of chewing (nicotine gum), 20 minutes after start of chewing (xylitol placebo gum), and 0 minutes (no gum) for the control condition; single 30-second trial per visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Gum 3mg/kg and Nicotine Gum (4 mg) in people with Athletic Performance and Postural Stability, run by Gülbin Rudarlı at 1 site in Turkey (Türkiye).
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 7 inclusion and 4 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: finished, as of the sponsor's last update on 4 Dec 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static Postural Sway Ellipse Area - ProKin 252 Stabilometric Platform (time frame: At each visit: 5 minutes after start of chewing (caffeine gum), 30 minutes after start of chewing (nicotine gum), 20 minutes after start of chewing (xylitol placebo gum), and 0 minutes (no gum) for the control condition; single 30-second trial per visit). 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 4 Dec 2025.