CaffeineNCT07386899
5 vs 10-Minute Chewing of Caffeinated Gum: Plasma Caffeine Pharmacokinetics
A study testing Caffeine 300 MG in people with Caffeine, run by Ege University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Caffeine
- What is being tested?
- Caffeine 300 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Apr 2025to 14 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male, 18-35 years
- Good general health
- No regular use of medications or substances
- Habitual daily caffeine intake ≤300 mg/day
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University, Faculty of Sport Sciences
Izmir, Bornova, 35040
About this study
Official title: Optimizing the Timing of Caffeinated Gum: Effects of 5- and 10-Minute Chewing on Plasma Caffeine Pharmacokinetics in Healthy Men
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.
Read the detailed description
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.
- Conditions
- Caffeine
- Being tested
- Caffeine 300 MG
- Keywords
- Pharmacokinetics, Plasma caffeine, Caffeinated chewing gum, Chewing duration, Absorption, Time to peak, Peak concentration, AUC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeine 300 MGDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 5-Minute Chewing | Experimental | Participants chew caffeinated chewing gum for 5 minutes (total caffeine approximately 300 mg). Receives: Dietary Supplement: Caffeine 300 MG |
| 10-Minute Chewing | Experimental | Participants chew caffeinated chewing gum for 10 minutes (total caffeine approximately 300 mg). Receives: Dietary Supplement: Caffeine 300 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 0 to 180 minutes post-chewing
Secondary outcomes (3)
Duration Plasma Caffeine Remains at or Above 90% of Individual Peak (Sustain90)
Duration (minutes) during which plasma caffeine concentration is at or above 90% of the individual Cpeak within the 0-180 minute sampling period.
Measured: 0 to 180 minutes post-chewing
Duration Plasma Caffeine Remains at or Above 80% of Individual Peak (Sustain80)
Duration (minutes) during which plasma caffeine concentration is at or above 80% of the individual Cpeak within the 0-180 minute sampling period.
Measured: 0 to 180 minutes post-chewing
Plasma Caffeine Concentration-Time Profile
Plasma caffeine concentrations (µg/mL) measured at prespecified time points: 0, 5, 10 (10-minute condition only), 30, 50, 60, 80, 90, 120, and 180 minutes post-chewing, analyzed by LC-MS/MS.
Measured: Baseline (0 minutes) through 180 minutes post-chewing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start22 Apr 2025
- Primary completion14 Jun 2025
- Study completion14 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CaffeineStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Gülbin Rudarlı, Ege University
- Investigators
- Hakan Arslan, Dr., Principal investigator, Ege UniversityGülbin Rudarlı, professor, Study chair, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386899
- Sponsor's protocol ID
- CAF-GUMPK-5v10-324S220
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11839447
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Timing of Caffeinated Gum: Effects of 5- and 10-Minute Chewing on Plasma Caffeine Pharmacokinetics in Healthy Men
- ClinicalTrials.gov ID
- NCT07386899
- Acronym / sponsor ID
- CAF-GUMPK-5v10-324S220
- Conditions
- Caffeine
- Keywords
- Pharmacokinetics, Plasma caffeine, Caffeinated chewing gum, Chewing duration, Absorption, Time to peak, Peak concentration, AUC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 14 Jun 2025 (actual)
- Study completion
- 14 Jun 2025 (actual)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 5-Minute Chewing | Experimental | Dietary Supplement: Caffeine 300 MGParticipants chew caffeinated chewing gum for 5 minutes (total caffeine approximately 300 mg). |
| 10-Minute Chewing | Experimental | Dietary Supplement: Caffeine 300 MGParticipants chew caffeinated chewing gum for 10 minutes (total caffeine approximately 300 mg). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male, 18-35 years
- Good general health
- No regular use of medications or substances
- Habitual daily caffeine intake ≤300 mg/day
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caffeine 300 MG300 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. | Dietary supplement | 10-Minute Chewing, 5-Minute Chewing |
Primary outcome
Peak Plasma Caffeine Concentration (Cpeak)
Time frame: 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)
Time frame: 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)
Time frame: 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.
3 secondary outcomes
Duration Plasma Caffeine Remains at or Above 90% of Individual Peak (Sustain90)
Time frame: 0 to 180 minutes post-chewing
Duration Plasma Caffeine Remains at or Above 80% of Individual Peak (Sustain80)
Time frame: 0 to 180 minutes post-chewing
Plasma Caffeine Concentration-Time Profile
Time frame: Baseline (0 minutes) through 180 minutes post-chewing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Results publication: PubMed 11839447Kamimori 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hakan Arslan, Dr. principal investigator
Ege University
Gülbin Rudarlı, professor study chair
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeine 300 MG in people with Caffeine, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma Caffeine Concentration (Cpeak) (time frame: From baseline (0 minutes) up to 180 minutes post-chewing). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07386899, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.