NCT06881316

Brief Summary

The present study evaluated the influence of carbohydrate mouth-rinsing (CHO-MR), caffeine mouth-rinsing (CAF-MR), and control-substance mouth rinses on Loughborough soccer passing test (LSPT) performance. The study participants were involved in a randomized, double-blind, repeated-measures design that employed four sessions (familiarization, CHOMR, CAFMR, and CONT) over ten days at a testing facility. Participants took part in six test sessions 72 hours apart. In the CHO group, 6% w/v glucose solution was used. In the CAFF group, 6% w/v glucose solution was used. CONT group, only exercise was performed without any condition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

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

February 10, 2025

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2025

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 18, 2025

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

15 days

First QC Date

March 5, 2025

Last Update Submit

March 10, 2025

Conditions

Keywords

Performancecaffeine mouth-rinsingcarbohydrate mouth-rinsingcognitive-motor functiontechnical skill execution

Outcome Measures

Primary Outcomes (4)

  • Psychophysiological Responses-Heart Rate

    Participants used a Polar H10 heart rate (HR) transmitter synchronized with a Polar V800 watch to track the HR throughout the session. Participants' heart rate mean, heart rate peak and heart rate percentage were recorded.

    From baseline to the end of treatment at 2 weeks

  • Psychophysiological Responses-Rating of Perceived Exertion

    Exercise intensity in all test sessions was quantified using the rating of perceived exertion (RPE), which employs a category ratio scale ranging from 6 to 20. This scale has recently been applied in sports psychology to assess effort related to emotions and performance during competitive events.

    From baseline to the end of treatment at 2 weeks

  • Psychophysiological Responses-Enjoyment-Brunel mood of states

    all participants completed the exercise enjoyment scale (EES), which comprises eight items rated on a 1-7 Likert scale. This scale has been validated to measure enjoyment in Turkish adolescents and adults. To assess subjective mental fatigue levels, participants were instructed to indicate their degree of mental fatigue on a Visual Analog Scale (VAS).

    From baseline to the end of treatment at 2 weeks

  • Loughborough Soccer Passing Test (LSPT)

    Participants were informed that the LSPT was a timed performance assessment and instructed to complete it as expeditiously as possible while minimizing penalties. The LSPT comprises 16 passes: eight short passes to red and white targets 3.5m from the passing zone and eight slightly longer passes to green and blue targets 4m away. Targets were constructed by affixing colored cards (0.3 x 0.6m) to the center of standard gymnasium benches, with a vertical aluminum strip (0.1 x 0.15m) fixed to the target's center for auditory feedback on successful passes. Four randomized passing sequences were generated. An examiner announces that the subsequent target color is released immediately after the previous pass. A stopwatch measured the test duration, commencing when the participant moved the ball into the passing zone and concluding when the final pass contacted the target area.

    From baseline to the end of treatment at 2 weeks

Secondary Outcomes (1)

  • Anthropometric Measurements 1

    Baseline

Other Outcomes (2)

  • Anthropometric Measurements 2

    Baseline

  • Anthropometric Measurements 3

    Baseline

Study Arms (3)

Caffeine Mouth Rinse Protocol (CAF-MR)

EXPERIMENTAL

Caffeine solutions (1.2% w/v caffeine solution) were prepared in an equivalent saccharin base to ensure indistinguishability within the Falcon Sterile Tube and agitated for 30 seconds on a vortex mixer. Participants were instructed to avoid intense activity 24 hours before testing, observe a 2-hour fast before sessions, and abstain from caffeinated products on test days. The following three sessions were test trials conducted between 15.00 h and 17.00 h at 32°C and 40% humidity.

Other: Caffeine

CHO Mouth Rinse Protocol (CHO-MR)

EXPERIMENTAL

CHO solutions (6% w/v glucose solution) were prepared in an equivalent saccharin base to ensure indistinguishability within the Falcon Sterile Tube and agitated for 30 seconds on a vortex mixer. Participants were instructed to avoid intense activity 24 hours before testing, observe a 2- hour fast before sessions, and abstain from caffeinated products on test days. The following three sessions were test trials conducted between 15.00 h and 17.00 h at 32°C and 40% humidity.

Other: CHO

Control Condition

EXPERIMENTAL

Only exercise was performed without any condition.

Other: Control

Interventions

Participants' solutions were prepared in separate Falcon Sterile Tubes: LSPTCAFF (1.2% w/v caffeine solution, Nature's Supreme). An MRI was performed before the LSPT. The solution was sweetened with non-caloric artificial sweeteners consisting of sucralose. The caffeine solution was prepared in an equivalent saccharin base and shaken for 30 seconds in a vortex mixer to ensure distinguishability. Participants swished the solution in their mouth for 10 seconds before LSPT and then emptied it back into the container to be weighed again. To ensure that the solutions were not swallowed, the containers were measured before and after all MRs using a full precision balance (Etekcity, USA) accurate to 1 g/0.04 oz.

Caffeine Mouth Rinse Protocol (CAF-MR)
CHOOTHER

Participants' solutions were prepared in separate Falcon Sterile Tubes: LSPTCHO (6% w/ v glucose solution, Protein Ocean, Turkey) An MRI was performed prior to LSPT. The solution was sweetened with non-caloric artificial sweeteners consisting of sucralose. The CHO solution was prepared in an equivalent saccharin base and shaken for 30 seconds in a vortex mixer to ensure distinguishability. Participants swished the solution in their mouth for 10 seconds before LSPT and then emptied it back into the container to be weighed again. To ensure that the solutions were not swallowed, the containers were measured before and after all MRs using a full precision balance (Etekcity, USA) accurate to 1 g/0.04 oz.

CHO Mouth Rinse Protocol (CHO-MR)
ControlOTHER

For the control condition, no supplements were taken and only exercise was performed.

Control Condition

Eligibility Criteria

Age14 Years - 16 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Being healthy
  • Male soccer players
  • Willing to maintain the intervention for all sessions

You may not qualify if:

  • Being under 14 years old
  • Having a chronic disease
  • Contraindication for caffeine mouth-rinsing (CAF-MR)
  • Contraindication for carbohydrate mouth-rinsing (CHO-MR)
  • Contraindications for exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokat Gaziosmanpasa Universty

Tokat Province, Turkey, 60000, Turkey (Türkiye)

Location

Related Publications (2)

  • Soylu Y, Ramazanoglu F, Arslan E, Clemente FM. Effects of mental fatigue on the psychophysiological responses, kinematic profiles, and technical performance in different small-sided soccer games. Biol Sport. 2022 Oct;39(4):965-972. doi: 10.5114/biolsport.2022.110746. Epub 2021 Dec 30.

    PMID: 36247954BACKGROUND
  • Soylu Y, Chmura P, Arslan E, Kilit B. The Effects of Carbohydrate Mouth Rinse on Psychophysiological Responses and Kinematic Profiles in Intermittent and Continuous Small-Sided Games in Adolescent Soccer Players: A Randomized, Double-Blinded, Placebo-Controlled, and Crossover Trial. Nutrients. 2024 Nov 15;16(22):3910. doi: 10.3390/nu16223910.

    PMID: 39599695BACKGROUND

MeSH Terms

Interventions

Caffeine

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Ersan Arslan, Doctorate

    +905325452848

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Participants were strictly separated and think their intervention is the main intervention. The same was true for care providers. Outcome assessors were unaware of participant group status and were not allowed to ask correspondingly.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Crossover Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

March 5, 2025

First Posted

March 18, 2025

Study Start

February 10, 2025

Primary Completion

February 25, 2025

Study Completion

February 26, 2025

Last Updated

March 18, 2025

Record last verified: 2025-03

Locations