NCT07099807

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

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 28, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 1, 2025

Completed
Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

July 25, 2025

Last Update Submit

July 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in prefrontal cortex oxygenation (ΔO2Hb)

    Immediately post-intervention and post-time trial (within same day)

Study Arms (3)

Carbohydrate Mouth Rinse

EXPERIMENTAL
Behavioral: Carbohydrate Mouth Rinse

Placebo Mouth Rinse

PLACEBO COMPARATOR
Behavioral: Placebo Mouth Rinse

Music Listening

EXPERIMENTAL
Behavioral: Music Listening

Interventions

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.

Carbohydrate Mouth Rinse

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.

Placebo Mouth Rinse
Music ListeningBEHAVIORAL

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.

Music Listening

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHA University, Human Performance Lab

Seongnam-si, Gyeonggi-do, 13488, South Korea

Location

Study Officials

  • Seung-Bo Park

    CHA University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
CHA Bundang Medical Center

Study Record Dates

First Submitted

July 25, 2025

First Posted

August 1, 2025

Study Start

February 28, 2025

Primary Completion

May 15, 2025

Study Completion

May 17, 2025

Last Updated

August 1, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations