Exercise Performance of Fit AthletesNCT07099807
Carbohydrate Mouth Rinsing and Cognitive Response During Exercise
A study testing Carbohydrate Mouth Rinse and Music Listening in people with Exercise Performance of Fit Athletes, run by CHA University at 1 site in South Korea.
Trial summary
This study investigates whether rinsing the mouth with a carbohydrate solution can improve brain oxygenation and cognitive function during high-intensity exercise. Eleven trained cyclists participated in multiple exercise sessions under different mouth rinse conditions. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Performance of Fit Athletes
- What is being tested?
- Carbohydrate Mouth Rinse and Music Listening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Feb 2025to 17 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 20 and 30 years
- Engaged in regular cycling training (≥5 sessions per week, ~4 hours per day)
- No known cardiovascular, neurological, or metabolic diseases
- Provided written informed consent
Who cannot join
- Current use of medication affecting cardiovascular or cognitive function
- Recent musculoskeletal injuries that affect cycling ability
- Smoking or excessive alcohol consumption
- Refusal or inability to comply with study procedures
Trial locations and contacts
1 site in 1 country.
South Korea1 site
CHA University, Human Performance Lab
Seongnam-si, Gyeonggi-do, 13488
About this study
Official title: Carbohydrate Mouth Rinsing Enhances Prefrontal Cortex Oxygenation and Cognitive Performance, Reducing Perceived Exertion During High-Intensity Exercise
This study investigates whether rinsing the mouth with a carbohydrate solution can improve brain oxygenation and cognitive function during high-intensity exercise. Eleven trained cyclists participated in multiple exercise sessions under different mouth rinse conditions. Brain oxygenation, perceived exertion, and cognitive performance were measured. The goal is to understand if this simple technique can support both physical and mental performance during demanding exercise.
- Conditions
- Exercise Performance of Fit Athletes
- Being tested
- Carbohydrate Mouth Rinse, Placebo Mouth Rinse, Music Listening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate Mouth RinseBehavioural
A 6.4% maltodextrin solution (64 g/L) was prepared using Nutricost Maltodextrin Powder. Participants performed five mouth rinses per trial, each using 25 mL of the solution for 10 seconds before expectorating. Each rinse was followed by a 30-second rest. Participants were instructed not to swallow the solution. Rinsing procedure was standardized across all sessions.
Placebo Mouth RinseBehavioural
A placebo solution containing 0.05 g/L of non-caloric sucralose in distilled water was used to match sweetness and viscosity of the CHO-MR. Participants performed five rinses of 25 mL for 10 seconds each, spitting out the solution after each rinse. 30-second rest intervals followed each rinse. Swallowing was not allowed. Rinse frequency, volume, and duration were standardized.
Music ListeningBehavioural
Participants listened to high-tempo music (120 bpm) for 15 minutes before exercise using standardized earbuds. Music was selected from a public YouTube playlist titled "120 BPM Best Dance Music for Running and Working Out." Volume was calibrated at 65 dB (50% of max device volume). Auditory conditions were standardized across all participants.
| Study group | Role | What they receive |
|---|---|---|
| Carbohydrate Mouth Rinse | Experimental | Not described Receives: Behavioral: Carbohydrate Mouth Rinse |
| Placebo Mouth Rinse | Placebo comparator | Not described Receives: Behavioral: Placebo Mouth Rinse |
| Music Listening | Experimental | Not described Receives: Behavioral: Music Listening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in prefrontal cortex oxygenation (ΔO2Hb)
Measured: Immediately post-intervention and post-time trial (within same day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start28 Feb 2025
- Primary completion15 May 2025
- Study completion17 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exercise Performance of Fit AthletesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHA University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Park Seung-Bo, CHA University
- Investigators
- Seung-Bo Park, Principal investigator, CHA University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099807
- Sponsor's protocol ID
- Parks0524
- Status last verified
- Jul 2025
- First submitted
- 25 Jul 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park SB, Oh K, Yang G, Kim T, Lee JW, Jeon HJ, Han DH. Oral carbohydrate sensing enhances prefrontal cortex oxygenation, reduces perceived exertion, and improves high-intensity cycling performance: A randomized crossover trial. PLoS One. 2026 May 12;21(5):e0349067. doi: 10.1371/journal.pone.0349067. eCollection 2026.
PubMed 42118778
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbohydrate Mouth Rinsing Enhances Prefrontal Cortex Oxygenation and Cognitive Performance, Reducing Perceived Exertion During High-Intensity Exercise
- ClinicalTrials.gov ID
- NCT07099807
- Acronym / sponsor ID
- Parks0524
- Conditions
- Exercise Performance of Fit Athletes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- CHA UniversityUniversity, hospital or other
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 17 May 2025 (actual)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates whether rinsing the mouth with a carbohydrate solution can improve brain oxygenation and cognitive function during high-intensity exercise. Eleven trained cyclists participated in multiple exercise sessions under different mouth rinse conditions. Brain oxygenation, perceived exertion, and cognitive performance were measured. The goal is to understand if this simple technique can support both physical and mental performance during demanding exercise.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate Mouth Rinse | Experimental | Behavioral: Carbohydrate Mouth Rinse |
| Placebo Mouth Rinse | Placebo comparator | Behavioral: Placebo Mouth Rinse |
| Music Listening | Experimental | Behavioral: Music Listening |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged between 20 and 30 years
- Engaged in regular cycling training (≥5 sessions per week, ~4 hours per day)
- No known cardiovascular, neurological, or metabolic diseases
- Provided written informed consent
Key exclusion criteria (4 listed)
- Current use of medication affecting cardiovascular or cognitive function
- Recent musculoskeletal injuries that affect cycling ability
- Smoking or excessive alcohol consumption
- Refusal or inability to comply with study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbohydrate Mouth RinseA 6.4% maltodextrin solution (64 g/L) was prepared using Nutricost Maltodextrin Powder. Participants performed five mouth rinses per trial, each using 25 mL of the solution for 10 seconds before expectorating. Each rinse was followed by a 30-second rest. Participants were instructed not to swallow the solution. Rinsing procedure was standardized across all sessions. | Behavioural | Carbohydrate Mouth Rinse |
| Placebo Mouth RinseA placebo solution containing 0.05 g/L of non-caloric sucralose in distilled water was used to match sweetness and viscosity of the CHO-MR. Participants performed five rinses of 25 mL for 10 seconds each, spitting out the solution after each rinse. 30-second rest intervals followed each rinse. Swallowing was not allowed. Rinse frequency, volume, and duration were standardized. | Behavioural | Placebo Mouth Rinse |
| Music ListeningParticipants listened to high-tempo music (120 bpm) for 15 minutes before exercise using standardized earbuds. Music was selected from a public YouTube playlist titled "120 BPM Best Dance Music for Running and Working Out." Volume was calibrated at 65 dB (50% of max device volume). Auditory conditions were standardized across all participants. | Behavioural | Music Listening |
Primary outcome
Changes in prefrontal cortex oxygenation (ΔO2Hb)
Time frame: Immediately post-intervention and post-time trial (within same day)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Derived from this study: PubMed 42118778Park SB, Oh K, Yang G, Kim T, Lee JW, Jeon HJ, Han DH. Oral carbohydrate sensing enhances prefrontal cortex oxygenation, reduces perceived exertion, and improves high-intensity cycling performance: A randomized crossover trial. PLoS One. 2026 May 12;21(5):e0349067. doi: 10.1371/journal.pone.0349067. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seung-Bo Park principal investigator
CHA University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate Mouth Rinse and Music Listening in people with Exercise Performance of Fit Athletes, run by CHA University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in prefrontal cortex oxygenation (ΔO2Hb) (time frame: Immediately post-intervention and post-time trial (within same day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07099807, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.