Optimizing the Timing of Caffeinated Gum: Effects of 5- and 10-Minute Chewing on Plasma Caffeine Pharmacokinetics in Healthy Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Peak Plasma Caffeine Concentration (Cpeak)
研究概览
简要总结
The goal of this study is to understand how chewing duration affects how quickly caffeine from caffeinated chewing gum appears in the blood and how long higher caffeine levels are maintained. The study compares two chewing durations (5 minutes and 10 minutes) in healthy men.
Each participant attends two study visits on separate days at least 48 hours apart and completes both chewing conditions. At each visit, participants chew caffeinated gum that provides approximately 300 mg of caffeine. Blood samples are collected before chewing and at several time points for up to 3 hours after chewing to measure plasma caffeine levels.
Researchers will compare the two chewing durations to determine whether chewing time changes peak plasma caffeine concentration, the time to reach the peak, overall exposure over 0 to 180 minutes, and the time that plasma caffeine remains near the peak level. The results may help guide practical timing of caffeinated gum use.
详细描述
This is a within-subject, repeated-measures, two-visit, fixed-sequence study comparing two chewing durations of caffeinated gum (5 minutes vs 10 minutes). Participants attend two visits on separate days with at least 48 hours between visits to minimize carryover effects. The order is fixed: the 5-minute chewing condition is completed at Visit 1 and the 10-minute chewing condition at Visit 2.
At each visit, participants receive approximately 300 mg of caffeine via commercially available caffeinated chewing gum (three pieces; about 100 mg per piece). Venous blood samples are collected to measure plasma caffeine concentration over time. Samples are obtained at baseline (0 minutes), during chewing (5 minutes in both conditions and 10 minutes only in the 10-minute condition), and after chewing at 30, 50, 60, 80, 90, 120, and 180 minutes. Plasma caffeine is quantified using liquid chromatography-tandem mass spectrometry (LC-MS/MS).
The plasma caffeine concentration-time profile is used to derive pharmacokinetic outcomes, including peak plasma caffeine concentration, time to peak concentration, exposure from 0 to 180 minutes, and the duration that plasma caffeine remains at or above 90% and 80% of the individual peak concentration.
The study was approved by the Ege University Faculty of Medicine Medical Research Ethics Committee, and written informed consent was obtained from all participants prior to participation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male, 18-35 years
- •Good general health
- •No regular use of medications or substances
- •Habitual daily caffeine intake ≤300 mg/day
排除标准
- •Habitual daily caffeine intake >300 mg/day
- •Failure to participate in any study measurements
- •Failure to comply with required test and measurement protocols
- •Experiencing adverse effects from caffeine during the compliance period
研究组 & 干预措施
5-Minute Chewing
Participants chew caffeinated chewing gum for 5 minutes (total caffeine approximately 300 mg).
干预措施: Caffeine 300 MG (Dietary Supplement)
10-Minute Chewing
Participants chew caffeinated chewing gum for 10 minutes (total caffeine approximately 300 mg).
干预措施: Caffeine 300 MG (Dietary Supplement)
结局指标
主要结局
Peak Plasma Caffeine Concentration (Cpeak)
时间窗: From baseline (0 minutes) up to 180 minutes post-chewing
Highest observed plasma caffeine concentration over the 0-180 minute sampling period, quantified from venous blood samples analyzed by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Unit: µg/mL.
Time to Peak Plasma Caffeine Concentration (Tpeak)
时间窗: From baseline (0 minutes) up to 180 minutes post-chewing
Time (minutes) from baseline (start of sampling) to the individual peak plasma caffeine concentration (Cpeak) within the 0-180 minute sampling period.
Area Under the Plasma Caffeine Concentration-Time Curve From 0 to 180 Minutes (AUC0-180)
时间窗: 0 to 180 minutes post-chewing
Total plasma caffeine exposure from 0 to 180 minutes calculated from measured plasma caffeine concentrations (trapezoidal method). Unit:mg·h/L.
次要结局
- Duration Plasma Caffeine Remains at or Above 90% of Individual Peak (Sustain90)(0 to 180 minutes post-chewing)
- Duration Plasma Caffeine Remains at or Above 80% of Individual Peak (Sustain80)(0 to 180 minutes post-chewing)
- Plasma Caffeine Concentration-Time Profile(Baseline (0 minutes) through 180 minutes post-chewing)