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ExerciseEarly Phase 1NCT06612463

Caffeine Supplementation on Movement Patterns and Reactive Agility in Rugby Sevens Matches

A Early Phase 1 study testing Caffeine 6mg/kg in people with Exercise, run by National Taiwan Sport University at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Caffeine is widely used by rugby players for its performance-enhancing effects. The main questions it aims to answer are: (1) the impact of caffeine supplementation on various performance metrics, including distance covered at different speeds, acceleration, deceleration, collisions, and repeated high-intensity… Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Exercise
What is being tested?
Caffeine 6mg/kg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
8 participants
Where
1 siteTaiwan
Study dates
1 Aug 2023to 30 Apr 2024
Phase
Early Phase 1
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 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Have undergone regular rugby training for at least three years
  • Member of a Division I university rugby team

Who cannot join

  • Musculoskeletal injury within one month prior to the study
  • Presence of major cardiovascular diseases
  • Presence of major metabolic diseases

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Taiwan University of Sport

    Taichung, 404

Other trials in Taiwan

About this study

Official title: Effect of Caffeine Supplementation on Movement Patterns and Reactive Agility in Rugby Sevens Matches

Caffeine is widely used by rugby players for its performance-enhancing effects. The main questions it aims to answer are: (1) the impact of caffeine supplementation on various performance metrics, including distance covered at different speeds, acceleration, deceleration, collisions, and repeated high-intensity efforts; and (2) reactive agility, across four matches over two consecutive days in collegiate male rugby sevens players.A position-matched, double-blind, randomized crossover design was employed, with six male collegiate rugby players (mean height: 1.78 ± 0.09 m, mean weight: 81.3 ± 9.2 kg) participating in two trials. Each trial consisted of a two-day tournament, with two matches per day. Movement was monitored using global positioning system units.

Read the detailed description

This study employed a position-matched, double-blind, randomized crossover design. Pairs of participants with similar playing positions, specifically forwards or backs/scrum halves, were randomly assigned to either the caffeine or placebo trial. Each trial comprised a two-day rugby sevens tournament, with participants playing two matches per day. Following a 13-day washout period, participants switched to the alternate trial. Both the participants and the research personnel were blinded to the supplementation condition throughout the study period, with the assignment of supplements disclosed to research personnel only after all data analyses were completed.

Conditions
Exercise
Being tested
Caffeine 6mg/kg, Placebo
Keywords
caffeine, rugby sevens, global positioning system
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Caffeine 6mg/kgDietary supplement

    In the caffeine trial, participants ingested a capsule containing 3 mg/kg caffeine 60 min prior to each rugby sevens match. There was 2 matches per day. So the total dosage is 6 mg/kg/ day

  • PlaceboDietary supplement

    In the placebo trial, participants ingested a capsule containing starch 60 min before each rugby sevens match. There were 2 matches per day

Study groups in NCT06612463
Study groupRoleWhat they receive
CaffeineExperimentalIn the caffeine trial, participants ingested a capsule containing 3 mg/kg caffeine (Wako Pure Chemical Industries, Ltd., Osaka, Japan) 60 min prior to the match.
Receives: Dietary Supplement: Caffeine 6mg/kg
PlaceboPlacebo comparatorIn the placebo trial, participants ingested a capsule containing starch (Chung-Yu Biotech Co LTD, Taichung, Taiwan) at the same time point.
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Distance and Distance Covered in Speed Zones

    This variable was measured with wearable global positioning system device during rugby sevens matches. Speed is divided into six zones: standing and walking (0-6 km/h), jogging (6-12 km/h), cruising (12-14 km/h), striding (14-18 km/h), high-intensity running (18-20 km/h), and sprinting (\> 20 km/h). The distance covered in each speed zone and the total distance covered were recorded.

    Measured: Each trial contained 2 days, with 2 matches on each day. Each participant completed 2 trials

  2. Acceleration and Deceleration

    This variable was measured with wearable global positioning system device during rugby sevens matches. For an activity to be included in the analysis, the movement speed must exceed 5 km/h, and the acceleration must be greater than 2 m/s² or the deceleration must be less than -2 m/s², sustained for more than 0.9 s. If the interval between two movements is less than 1 s, the subsequent movement will be combined with the previous one for analysis. The frequency and distance covered during these acceleration and deceleration phases were recorded.

    Measured: Each trial contained 2 days, with 2 matches on each day. Each participant completed 2 trials

  3. collision

    This variable was measured with wearable global positioning system device during rugby sevens matches. Collision is defined as the number of times a participant accumulates 0.5 s standing after body contact resulting in a fall. Specific collision events include rucks, tackles, and instances where a player falls after contact

    Measured: Each trial contained 2 days, with 2 matches on each day. Each participant completed 2 trials

  4. Repeated High-Intensity Effort

    This variable was measured with wearable global positioning system device during rugby sevens matches. A repeated high-intensity effort is defined as the completion of three or more high-intensity actions in succession, with rest periods of no more than 21 s between each action. The criteria for high-intensity actions include a movement speed of at least 14 km/h, an acceleration of at least 2 m/s², and a deceleration of at least -2 m/s²

    Measured: Each trial contained 2 days, with 2 matches on each day. Each participant completed 2 trials

  5. Reactive Agility

    The participants sprinted with the ball, passing through a light gate, after which an indicator light immediately displayed a left or right direction. The participants had to respond by changing direction according to the indicator and continue moving until they passed the second light gate positioned 1.5 m away from the indicator. The fastest time from two attempts was used for analysis.

    Measured: Each trial contained 2 days, with 2 matches on each day. Reactive agility was measured before each match. Each participant completed 2 trials

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2024
  2. Study start1 Aug 2023
  3. Primary completion30 Oct 2023
  4. Study completion30 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Crossover
Model description
2 types of Intervention: caffeine or placebo. Arm 1: Caffeine trial: Participants ingested a capsule containing 3 mg/kg caffeine (Wako Pure Chemical Industries, Ltd., Osaka, Japan) 60 min prior to the match. Arm 2: Placebo trial: Participants ingested a capsule containing starch (Chung-Yu Biotech Co LTD, Taichung, Taiwan) at the same time point. The capsules used in both trials were identical in appearance. The caffeine and placebo supplements were prepared by a laboratory technician who was independent of the study.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06612463
Sponsor's protocol ID
111-03
Other IDs
MOST 111-2410-H-028-002-MY3
Status last verified
Sep 2024
First submitted
21 Sep 2024
Last updated
1 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Del Coso J, Portillo J, Munoz G, Abian-Vicen J, Gonzalez-Millan C, Munoz-Guerra J. Caffeine-containing energy drink improves sprint performance during an international rugby sevens competition. Amino Acids. 2013 Jun;44(6):1511-9. doi: 10.1007/s00726-013-1473-5. Epub 2013 Mar 5.

    PubMed 23462927

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Caffeine 6mg/kg in people with Exercise, run by National Taiwan Sport University 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 2 inclusion and 3 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 1 Oct 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Total Distance and Distance Covered in Speed Zones (time frame: Each trial contained 2 days, with 2 matches on each day. Each participant completed 2 trials). The study lists 5 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 NCT06612463, 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 1 Oct 2024.

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