Optimizing the Timing of Caffeinated Gum: Effects of 5- and 10-Minute Chewing on Plasma Caffeine Pharmacokinetics in Healthy Men
| Registry | NCT07386899 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; non randomized, crossover, masking: none, basic science |
| Enrollment | 30 (Actual) |
| Sponsor | Ege University (Other); collaborators: The Scientific and Technological Research Council of Turkey |
| Conditions | Caffeine |
| Interventions | Caffeine 300 MG (Dietary supplement) |
| Dates | start 2025-04-22, primary completion 2025-06-14, completion 2025-06-14, first posted 2026-02-04, last updated 2026-02-04 |
| Locations | 1 site in Turkey (Türkiye) |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 5-Minute Chewing | Experimental | Dietary Supplement: Caffeine 300 MG | Participants chew caffeinated chewing gum for 5 minutes (total caffeine approximately 300 mg). |
| 10-Minute Chewing | Experimental | Dietary Supplement: Caffeine 300 MG | Participants chew caffeinated chewing gum for 10 minutes (total caffeine approximately 300 mg). |
Sex: Male, ages: 18 Years to 35 Years, accepts healthy volunteers
Inclusion Criteria: * Male, 18-35 years * Good general health * No regular use of medications or substances * Habitual daily caffeine intake ≤300 mg/day Exclusion Criteria: * 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
| Facility | City | Country | Status |
|---|---|---|---|
| Ege University, Faculty of Sport Sciences | Izmir, Bornova | Turkey (Türkiye) |