CaffeineNCT06430996
Caffeinated Chewing Gum on 400-meter Performance
A study testing caffeine in people with Caffeine and Placebo, run by Chih-Hui Chiu at 1 site in Taiwan.
Trial summary
20 trained sprinter were divided into caffeine Gum trial (CAF) and Placebo trial (PL) with a randomized, double-blind study design. The participants chewing either caffeine Gum (CAF trial, containing 3 mg/kg of caffeine) or Placebo Gum (PL) for 10 minutes. Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- What is being tested?
- caffeine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Apr 2024to 1 Jul 2024
- 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 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 6 years of professional short sprinting training
- 6 months of ongoing training, and
- 3 months of recovery from sports injuries such as strains and sprains.
Who cannot join
- Non-specialized sprinters.
- has not trained regularly for the past 6 months.
- has recovered from an athletic injury.
- less than 3 months of recovery from a sports injury, or participants with epilepsy, hypertension, hyperlipidemia, heart disease, arthritis, osteoporosis, brain injury, or a history of caffeine allergy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Caffeinated Chewing Gum on 400-meter Performance and Fatigue Index of Sprinters: a Crossover Trial
20 trained sprinter were divided into caffeine Gum trial (CAF) and Placebo trial (PL) with a randomized, double-blind study design. The participants chewing either caffeine Gum (CAF trial, containing 3 mg/kg of caffeine) or Placebo Gum (PL) for 10 minutes. The outcomes are Running-Based Anaerobic Sprint Test and 400-meter sprint test was performed.
Read the detailed description
The purpose of this study was to investigate the effect of caffeinated chewing gum on 400-meter sprint performance. 20 trained sprinter were divided into caffeine Gum trial (CAF) and Placebo trial (PL) with a randomized, double-blind study design. The participants chewing either caffeine Gum (CAF trial, containing 3 mg/kg of caffeine) or Placebo Gum (PL) for 10 minutes. After rested for 15 minutes, the participants underwent a Running-Based Anaerobic Sprint Test. After a 30-minute break, a 400-meter sprint test was performed. The blood lactate concentration were collected before and after 400-meter sprint from finger. Saliva samples were predicted to be collected before chewing gum, before the RAST, and after a 400-meter sprint. Saliva samples will be analyzed for caffeine and α-amylase concentrations in saliva.
- Being tested
- caffeine
- Keywords
- exercise performance, fatigue index, α amylase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caffeineDietary supplement
Also called plocabo gum
The participants chewing either caffeine Gum (CAF trial, containing 3 mg/kg of caffeine) or Placebo Gum (PL) for 10 minutes. After rested for 15 minutes, the participants underwent tests.
| Study group | Role | What they receive |
|---|---|---|
| caffeine gum | Experimental | The participants chewing caffeine gum 10 minutes before exercise Receives: Dietary Supplement: caffeine |
| placebo gum | Placebo comparator | The participants chewing placebo gum 10 minutes before exercise Receives: Dietary Supplement: caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Running-Based Anaerobic Sprint Test (RAST)
Measure the fatigue index (%)
Measured: 15 minutes after intervention
400-meter sprinting
Measure the 400-meter completion time (seconds)
Measured: 30 minutes after RAST
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start8 Apr 2024
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaffeineStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chih-Hui Chiu
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council
- Responsible party
- Sponsor-investigator, Chih-Hui Chiu, National Taiwan Sport University
- Investigators
- ChihHui Chiu, PhD, Principal investigator, Sport Science Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06430996
- Sponsor's protocol ID
- 113-2
- Status last verified
- Aug 2024
- First submitted
- 8 Apr 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only participant number and relevant experimental data are provided.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Caffeinated Chewing Gum on 400-meter Performance and Fatigue Index of Sprinters: a Crossover Trial
- ClinicalTrials.gov ID
- NCT06430996
- Acronym / sponsor ID
- 113-2
- Keywords
- exercise performance, fatigue index, α amylase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Chih-Hui ChiuUniversity, hospital or other
- Collaborators
- National Science and Technology Council
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 28 May 2024 (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.
20 trained sprinter were divided into caffeine Gum trial (CAF) and Placebo trial (PL) with a randomized, double-blind study design. The participants chewing either caffeine Gum (CAF trial, containing 3 mg/kg of caffeine) or Placebo Gum (PL) for 10 minutes. The outcomes are Running-Based Anaerobic Sprint Test and 400-meter sprint test was performed.
Detailed description
The purpose of this study was to investigate the effect of caffeinated chewing gum on 400-meter sprint performance. 20 trained sprinter were divided into caffeine Gum trial (CAF) and Placebo trial (PL) with a randomized, double-blind study design. The participants chewing either caffeine Gum (CAF trial, containing 3 mg/kg of caffeine) or Placebo Gum (PL) for 10 minutes. After rested for 15 minutes, the participants underwent a Running-Based Anaerobic Sprint Test. After a 30-minute break, a 400-meter sprint test was performed. The blood lactate concentration were collected before and after 400-meter sprint from finger. Saliva samples were predicted to be collected before chewing gum, before the RAST, and after a 400-meter sprint. Saliva samples will be analyzed for caffeine and α-amylase concentrations in saliva.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| caffeine gum | Experimental | Dietary Supplement: caffeineThe participants chewing caffeine gum 10 minutes before exercise |
| placebo gum | Placebo comparator | Dietary Supplement: caffeineThe participants chewing placebo gum 10 minutes before exercise |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 6 years of professional short sprinting training
- 6 months of ongoing training, and
- 3 months of recovery from sports injuries such as strains and sprains.
Key exclusion criteria (4 listed)
- Non-specialized sprinters.
- has not trained regularly for the past 6 months.
- has recovered from an athletic injury.
- less than 3 months of recovery from a sports injury, or participants with epilepsy, hypertension, hyperlipidemia, heart disease, arthritis, osteoporosis, brain injury, or a history of caffeine allergy.
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 |
|---|---|---|
| caffeineAlso: plocabo gumThe participants chewing either caffeine Gum (CAF trial, containing 3 mg/kg of caffeine) or Placebo Gum (PL) for 10 minutes. After rested for 15 minutes, the participants underwent tests. | Dietary supplement | caffeine gum, placebo gum |
Primary outcome
Running-Based Anaerobic Sprint Test (RAST)
Time frame: 15 minutes after intervention
Measure the fatigue index (%)
400-meter sprinting
Time frame: 30 minutes after RAST
Measure the 400-meter completion time (seconds)
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 6 Aug 2024.
- Individual participant dataSharing planned: No. Only participant number and relevant experimental data are provided.
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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.
ChihHui Chiu, PhD principal investigator
Sport Science Research Center
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 in people with Caffeine and Placebo, run by Chih-Hui Chiu at 1 site in Taiwan.
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 3 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 6 Aug 2024. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
Running-Based Anaerobic Sprint Test (RAST) (time frame: 15 minutes after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2024.