NCT06612463

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Aug 2023

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2024

Completed
Last Updated

October 1, 2024

Status Verified

September 1, 2024

Enrollment Period

3 months

First QC Date

September 21, 2024

Last Update Submit

September 29, 2024

Conditions

Keywords

caffeinerugby sevensglobal positioning system

Outcome Measures

Primary Outcomes (5)

  • 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.

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

  • 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.

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

  • 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

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

  • 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

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

  • 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.

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

Study Arms (2)

Caffeine

EXPERIMENTAL

In 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.

Dietary Supplement: Caffeine 6mg/kg

Placebo

PLACEBO COMPARATOR

In the placebo trial, participants ingested a capsule containing starch (Chung-Yu Biotech Co LTD, Taichung, Taiwan) at the same time point.

Dietary Supplement: Placebo

Interventions

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

Caffeine
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

Placebo

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University of Sport

Taichung, 404, Taiwan

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Motor Activity

Interventions

Caffeine

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Chen-Kang Chang, PhD

    National Taiwan University of Sport

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 21, 2024

First Posted

September 25, 2024

Study Start

August 1, 2023

Primary Completion

October 30, 2023

Study Completion

April 30, 2024

Last Updated

October 1, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations