NCT07254832

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2024

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 8, 2025

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 28, 2025

Completed
Last Updated

December 4, 2025

Status Verified

November 1, 2025

Enrollment Period

3 months

First QC Date

July 8, 2025

Last Update Submit

November 26, 2025

Conditions

Athletic PerformancePostural StabilityHealhty

Keywords

Caffeinated chewing gumNicotine chewing gumCaffeineNicotineDynamic balancePostural controlEllipse areaPerimeter lengthTrained athletes

Outcome Measures

Primary Outcomes (1)

  • 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

    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

    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

Study Arms (4)

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.

Interventions

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.

caffeine gum
Nicotine Gum (4 mg)DIETARY_SUPPLEMENT

Participants chewed one piece of 4 mg nicotine gum for 30 minutes before undergoing balance testing.

Nicotine Gum
Placebo Gum (Xylitol)OTHER

Participants chewed xylitol-based sugar-free gum with no active substance for 20 minutes prior to testing.

Placebo Gum

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University, Faculty of Sport Sciences

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Nicotine Chewing GumXylitol

Intervention Hierarchy (Ancestors)

Chewing GumPlant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesTobacco Use Cessation DevicesTherapeuticsCandyFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesSugar AlcoholsAlcoholsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Sport Sciences, Department of Coaching Education

Study Record Dates

First Submitted

July 8, 2025

First Posted

November 28, 2025

Study Start

January 8, 2024

Primary Completion

April 5, 2024

Study Completion

July 2, 2024

Last Updated

December 4, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)