跳至主要内容
临床试验/NCT07254832
NCT07254832已完成不适用

No Significant Alterations in Balance Performance After Acute Caffeine and Nicotine Gum Intake in Trained Athletes

Gülbin Rudarlı1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年1月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Static Postural Sway Ellipse Area - ProKin 252 Stabilometric Platform

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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.

研究组 & 干预措施

Control

No Intervention

No chewing gum administered; participants completed balance testing without any intervention.

Placebo Gum

Placebo Comparator

干预措施: Placebo Gum (Xylitol) (Other)

caffeine gum

Experimental

干预措施: Caffeine Gum 3mg/kg (Dietary Supplement)

Nicotine Gum

Active Comparator

干预措施: Nicotine Gum (4 mg) (Dietary Supplement)

结局指标

主要结局

Static Postural Sway Ellipse Area - ProKin 252 Stabilometric Platform

时间窗: 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

次要结局

  • 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)

研究者

发起方
Gülbin Rudarlı
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gülbin Rudarlı

Professor of Sport Sciences, Department of Coaching Education

Ege University

研究点 (1)

Loading locations...

相似试验