5 vs 10-Minute Chewing of Caffeinated Gum: Plasma Caffeine Pharmacokinetics

NCT07386899 | Completed

• 1 other identifier: CAF-GUMPK-5v10-324S220
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Caffeine

Keywords

Pharmacokinetics; Plasma caffeine; Caffeinated chewing gum; Chewing duration; Absorption; Time to peak; Peak concentration; AUC

Outcome Measures

Primary Outcomes (3)

• Peak Plasma Caffeine Concentration (Cpeak)

  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.

  From baseline (0 minutes) up to 180 minutes post-chewing

• Time to Peak Plasma Caffeine Concentration (Tpeak)

  Time (minutes) from baseline (start of sampling) to the individual peak plasma caffeine concentration (Cpeak) within the 0-180 minute sampling period.

  From baseline (0 minutes) up to 180 minutes post-chewing

• Area Under the Plasma Caffeine Concentration-Time Curve From 0 to 180 Minutes (AUC0-180)

  Total plasma caffeine exposure from 0 to 180 minutes calculated from measured plasma caffeine concentrations (trapezoidal method). Unit:mg·h/L.

  0 to 180 minutes post-chewing

Secondary Outcomes (3)

• 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

Study Arms (2)

5-Minute Chewing

EXPERIMENTAL

Participants chew caffeinated chewing gum for 5 minutes (total caffeine approximately 300 mg).

Dietary Supplement: Caffeine 300 MG

10-Minute Chewing

EXPERIMENTAL

Participants chew caffeinated chewing gum for 10 minutes (total caffeine approximately 300 mg).

Dietary Supplement: Caffeine 300 MG

Interventions

Caffeine 300 MG DIETARY_SUPPLEMENT

300 mg (three pieces; \~100 mg each) administered at each visit. Participants chew for 5 minutes in one condition and 10 minutes in the other condition.

10-Minute Chewing; 5-Minute Chewing

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male, 18-35 years
• Good general health
• No regular use of medications or substances
• Habitual daily caffeine intake ≤300 mg/day

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Ege University, Faculty of Sport Sciences

Izmir, Bornova, 35040, Turkey (Türkiye)

Location

Related Publications (1)

• Kamimori GH, Karyekar CS, Otterstetter R, Cox DS, Balkin TJ, Belenky GL, Eddington ND. The rate of absorption and relative bioavailability of caffeine administered in chewing gum versus capsules to normal healthy volunteers. Int J Pharm. 2002 Mar 2;234(1-2):159-67. doi: 10.1016/s0378-5173(01)00958-9.

  PMID: 11839447 RESULT

MeSH Terms

Interventions

Caffeine

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Hakan Arslan, Dr.

  Ege University

  PRINCIPAL INVESTIGATOR

• Gülbin Rudarlı, professor

  Ege University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Two-condition, two-visit within-subject fixed-sequence crossover (5-min chewing at Visit 1; 10-min chewing at Visit 2), with ≥48 hours between visits.

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 4, 2026
• Study Start: April 22, 2025
• Primary Completion: June 14, 2025
• Study Completion: June 14, 2025
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)