NCT06990022

Brief Summary

The present study evaluated the influence of carbohydrate mouth-rinsing (CHO- MR) and placebo (PLA) conditions on the psychophysiological responses, kinematic profiles, and technical performance of young male soccer players in 4-Small sided games (SSGs). The study participants were involved in a randomized, double-blind, repeated-measures design that employed 3 sessions (familiarization, CHOMR and PLA) over fifteen days at a testing facility. Participants took part in two test sessions one week apart. CHO solution was a maltodextrin-based mixture containing 6.4% maltodextrin (Protein Ocean, Türkiye). The PLA solution consisted of pure water. Both solutions were made indistinguishable by incorporating 50 mg of a non-calorific artificial sweetener and 50 mg og sucralose (Fibrelle, Türkiye). A 25-ml bolus of 6.4% maltodextrin solution was utilized in a pre-weighed plastic cup, with sucralose water tested as PLA for each rinse solution.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2025

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2025

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 25, 2025

Completed
Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

15 days

First QC Date

May 12, 2025

Last Update Submit

May 19, 2025

Conditions

Keywords

Game-based trainingCarbohydrateGame performancePsychophysiologicalPerformance analysis

Outcome Measures

Primary Outcomes (9)

  • 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 consists of eight items rated on a 1-7 Likert scale. This scale has been validated to measure the enjoyment of exercise in Turkish adolescents and adults. 1 indicates no enjoyment and 7 indicates enjoyment.

    From baseline to the end of treatment at 2 weeks

  • Psychophysiological Reactions-Mood Rating

    A scale consisting of 24 items and six (6) subscales (anger, confusion, depression, fatigue, tension and vitality) was used in all testing sessions. The depression subscale of the scale is an indicator of depressed mood rather than clinical depression. C in all test sessions. The depression subscale of the scale is an indicator of depressed mood rather than clinical depression Participants were asked the question 'How are you feeling right now?' before and after the games and were asked to tick a number between 0 and 4 (0 = not at all, 1 = a little, 2 = moderately, 3 = quite a bit, 4 = extremely).

    From baseline to the end of treatment at 2 weeks

  • Psychophysiological Responses-Mental Fatigue Assessment

    All test sessions were assessed using the MF visual analogue scale (VAS). The VAS is a subjective rating scale that assesses an individual's perception or experience of a particular construct, such as fatigue. To measure MF using the VAS, individuals are typically presented with a horizontal line or scale with one end zero (0) meaning "no fatigue" or "not tired at all" and the other end one hundred (100) meaning "extremely tired" or "very tired". Participants are then asked to place a mark on the line indicating their perceived level of MF.

    From baseline to the end of treatment at 2 weeks

  • Evaluating the total distance (TD)

    During the SSG sessions, total distance (TD)data were recorded using a Global Navigation Satellite System (GNSS) with a frequency of 10 Hertz and a triaxial accelerometer (STATSports, Apex, Northern Ireland) with a frequency of 100 Hertz. All data recorded by the GNSS units were downloaded and processed using STAT Sports Software (Apex version 3.0.02011).

    From baseline to the end of treatment at 2 weeks

  • Assessment of high intensity running distance (HIMD)

    During the SSG sessions, high-intensity running distance (HIMD) data were recorded using a Global Navigation Satellite System (GNSS) with a frequency of 10 Hertz and a triaxial accelerometer (STATSports, Apex, Northern Ireland) with a frequency of 100 Hertz. All data recorded by the GNSS units were downloaded and processed using STAT Sports Software (Apex version 3.0.02011).

    From baseline to the end of treatment at 2 weeks

  • Evaluation of sprint (SD)

    During the SSG sessions, sprint (SD) data were recorded using a Global Navigation Satellite System (GNSS) with a frequency of 10 Hertz and a triaxial accelerometer (STATSports, Apex, Northern Ireland) with a frequency of 100 Hertz. All data recorded by the GNSS units were downloaded and processed using STAT Sport Software (Apex version 3.0.02011).

    From baseline to the end of treatment at 2 weeks

  • Evaluating acceleration (ACC) and deceleration (DCC)

    During the SSG sessions, acceleration (ACC) and deceleration (DCC) data were recorded using a Global Navigation Satellite System (GNSS) with a frequency of 10 Hertz and a triaxial accelerometer (STATSports, Apex, Northern Ireland) with a frequency of 100 Hertz. All data recorded by the GNSS units were downloaded and processed using STAT Sport Software (Apex version 3.0.02011).

    From baseline to the end of treatment at 2 weeks

Secondary Outcomes (3)

  • Anthropometric Measurements 1

    Baseline

  • Anthropometric Measurements 2

    Baseline

  • Anthropometric Measurements 3

    Baseline

Study Arms (2)

CHO Mouth Rinse Protocol (CHO-MR)

EXPERIMENTAL

CHO solution was a maltodextrin-based mixture containing 6.4% maltodextrin (Protein Ocean, Türkiye). An CHOMR was performed prior to SSGs.

Other: Carbohydrate

Placebo Protocol

EXPERIMENTAL

The PLA solution consisted of pure water. A mouth rinse was performed before the SSGs.

Other: Placebo

Interventions

CHO solution was a maltodextrin-based mixture containing 6.4% maltodextrin (Protein Ocean, Türkiye). An CHOMR was performed prior to SSGs. 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 SSGs 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)
PlaceboOTHER

The PLA solution consisted of purified water. Both solutions were made indistinguishable by adding 50 mg of non-calorific artificial sweetener and 50 mg of sucralose (Fibrelle, Turkey). A 25 ml bolus of 6.4% maltodextrin solution was used in a pre-weighed plastic container and sucralose water was tested as PLA for each rinse solution.

Placebo Protocol

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 carbohydrate mouth-rinsing (CHO-MR)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokat Gaiosmanpasa University

Tokat Province, Turkey, 6000, Turkey (Türkiye)

Location

Related Publications (2)

  • 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
  • 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

MeSH Terms

Conditions

Mental Fatigue

Interventions

Carbohydrates

Condition Hierarchy (Ancestors)

FatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Erdinc Gorgulu, Doctorate

    Tokat Gaziosmanpasa University

    PRINCIPAL INVESTIGATOR
  • Yusuf Soylu, Doctorate

    Tokat Gaziosmanpasa University

    STUDY CHAIR
  • Ersan Arslan, Doctorate

    Tokat Gaziosmanpasa University

    STUDY CHAIR
  • Bulent Kilit, Doctorate

    Tokat Gaziosmanpasa University

    STUDY CHAIR
  • Neil D. Clarke, Doctorate

    Birmingham City University

    STUDY CHAIR
  • Haitham Jahrami, Doctorate

    Ministry of Health, Manama, Bahrain

    STUDY CHAIR
  • Achraf Ammar, Doctorate

    Johannes Gutenberg University Mainz

    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

May 12, 2025

First Posted

May 25, 2025

Study Start

April 10, 2025

Primary Completion

April 25, 2025

Study Completion

April 26, 2025

Last Updated

May 25, 2025

Record last verified: 2025-05

Locations