- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06990022
- Original Trial
Carbohydrate Mouth Rinse (Small-Sided Soccer Games) (CHOMR-SSGs)
May 19, 2025 updated by: Ersan Arslan, Tokat Gaziosmanpasa University
Carbohydrate Mouth Rinse Reduces Perceived Exertion and Mental Fatigue, and Improves Technical Actions During Small-Sided Soccer Games
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The current study used a double-blind, randomized, and counterbalanced crossover design to compare the effects of CHOMR or PLA on psychophysiological, kinematic responses and technical actions during 4-a-side SSGs.
The study intervention programs lasted the same time of the day during separate training sessions in the in-season to avoid various chronobiological factors.
The average temperature was 30 °C, with a relative humidity of 35% of the baseline assessments.
Second assessments were recorded that the average temperature was 31 °C with a 35% relative humidity.
Before the SSGs sessions, anthropometric characteristics were assessed.
Players also completed the Yo-Yo Intermittent Recovery Test level 1 (YYIRTL-1) to balance the groups and equally distribute players among SSGs teams based on maximal oxygen uptake ( 2max).
The order of different SSGs (CHOMR or PLA) and solutions (MR or PLA) was determined by randomization (www.randomization.com).
Each SSGs was separated at least one week apart to minimize the potential negative impact of physical and psychological fatigue on game performance.
Continuous monitoring and recording of the heart rate (HR), rating of perceived exertion (RPE), enjoyment and mental fatigue (MF), kinematic responses, and technical actions were conducted during all SSGs.
Mood responses were assessed before and after each SSGs.
UEFA A licenced strength and conditioning coaches consistently implemented all SSGs sessions on an artificial soccer pitch with verbal coach encouragement.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tokat, Turkey, 6000
- Tokat Gaiosmanpasa University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Being healthy
- Male soccer players
- Willing to maintain the intervention for all sessions
Exclusion Criteria:
- Being under 14 years old
- Having a chronic disease
- Contraindication for carbohydrate mouth-rinsing (CHO-MR)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CHO Mouth Rinse Protocol (CHO-MR)
CHO solution was a maltodextrin-based mixture containing 6.4% maltodextrin (Protein Ocean, Türkiye).
An CHOMR was performed prior to SSGs.
|
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
|
|
Experimental: Placebo Protocol
The PLA solution consisted of pure water.
A mouth rinse was performed before the SSGs.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychophysiological Responses-Heart Rate
Time Frame: From baseline to the end of treatment at 2 weeks
|
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
Time Frame: From baseline to the end of treatment at 2 weeks
|
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
Time Frame: From baseline to the end of treatment at 2 weeks
|
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.
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From baseline to the end of treatment at 2 weeks
|
|
Psychophysiological Reactions-Mood Rating
Time Frame: From baseline to the end of treatment at 2 weeks
|
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).
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From baseline to the end of treatment at 2 weeks
|
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Psychophysiological Responses-Mental Fatigue Assessment
Time Frame: From baseline to the end of treatment at 2 weeks
|
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.
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From baseline to the end of treatment at 2 weeks
|
|
Evaluating the total distance (TD)
Time Frame: From baseline to the end of treatment at 2 weeks
|
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).
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From baseline to the end of treatment at 2 weeks
|
|
Assessment of high intensity running distance (HIMD)
Time Frame: From baseline to the end of treatment at 2 weeks
|
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)
Time Frame: From baseline to the end of treatment at 2 weeks
|
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)
Time Frame: From baseline to the end of treatment at 2 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anthropometric Measurements 1
Time Frame: Baseline
|
Before breakfast, participants had their weight (kg) measured using a body composition analyser (BC-418MA, Tanita Corp., Tokyo, Japan).
This device utilises bioelectrical impedance technology using multiple frequencies (ranging from 1 kHz to 50 kHz) to comprehensively assess body composition parameters.
|
Baseline
|
|
Anthropometric Measurements 2
Time Frame: Baseline
|
Before breakfast, participants had their height (cm) measured using a body composition analyser (BC-418MA, Tanita Corp., Tokyo, Japan).
This device utilises bioelectrical impedance technology using multiple frequencies (ranging from 1 kHz to 50 kHz) to comprehensively assess body composition parameters.
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Baseline
|
|
Anthropometric Measurements 3
Time Frame: Baseline
|
Before breakfast, participants had their body mass index (kg/m2) measured using a body composition analyser (BC-418MA, Tanita Corp., Tokyo, Japan).
This device utilises bioelectrical impedance technology using multiple frequencies (ranging from 1 kHz to 50 kHz) to comprehensively assess body composition parameters.
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Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Erdinc Gorgulu, Doctorate, Tokat Gaziosmanpasa University
- Study Chair: 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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 10, 2025
Primary Completion (Actual)
April 25, 2025
Study Completion (Actual)
April 26, 2025
Study Registration Dates
First Submitted
May 12, 2025
First Submitted That Met QC Criteria
May 19, 2025
First Posted (Actual)
May 25, 2025
Study Record Updates
Last Update Posted (Actual)
May 25, 2025
Last Update Submitted That Met QC Criteria
May 19, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UGaziosmanpasa-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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