Effects of Caffeine and Nicotine Gum on Balance Performance in Athletes

November 26, 2025 updated by: Gülbin Rudarlı

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Izmir, Turkey (Türkiye)
        • Ege University, Faculty of Sport Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Be healthy, with no diagnosed neurological or musculoskeletal disorders
  2. Be physically active and have at least 3 years of regular training history
  3. Be between 18 and 30 years of age
  4. Have no balance impairments or vestibular issues
  5. Be non-smoker or not using tobacco during study days
  6. Able to comply with the intervention protocols and attend all test sessions
  7. Provide written informed consent

Exclusion Criteria:

  1. Training age less than three years,
  2. Having a disease or sports injury that will affect balance performance,
  3. Using a drug or substance that affects balance,
  4. Not being able to comply with or continue the study measurements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: caffeine gum
Participants chewed 2-3 pieces of 100 mg caffeine gum (~3 mg/kg total) for 5 minutes prior to balance testing.
Active Comparator: Nicotine Gum
Participants chewed one piece of 4 mg nicotine gum for 30 minutes before undergoing balance testing.
Placebo Comparator: Placebo Gum
Participants chewed xylitol-based sugar-free gum with no active substance for 20 minutes prior to testing.
No Intervention: Control
No chewing gum administered; participants completed balance testing without any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2024

Primary Completion (Actual)

April 5, 2024

Study Completion (Actual)

July 2, 2024

Study Registration Dates

First Submitted

July 8, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Estimated)

November 28, 2025

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

November 26, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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