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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • Tokat, Turkey, 6000
        • Tokat Gaiosmanpasa University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Carbohydrate
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.
Other: Placebo
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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).
From baseline to the end of treatment at 2 weeks
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.
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).
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tokat Gaziosmanpasa University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 10, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 25, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 26, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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