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Effect of Antibacterial Mouthwash on Muscle Function in Healthy Young Men and Women

Effect of Antibacterial Mouthwash on Muscle Function in Healthy Young Men and Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04095442
Enrollment
32
Registered
2019-09-19
Start date
2019-11-01
Completion date
2023-03-20
Last updated
2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quadriceps Muscle

Keywords

muscle power, nitric oxide, muscle speed, oral microbiome

Brief summary

The purpose of this study is to determine the effects of antibacterial mouthwash on muscle speed and power in healthy young men and women. We have previously demonstrated that drinking beetroot juice, a source of dietary nitrate and therefore nitric oxide, increases muscle function in this population. Antibacterial mouthwash has been shown to interfere with the conversion of dietary nitrate to nitric oxide. We therefore hypothesize that it will diminish nitric oxide bioavailability and inhibit muscle contractility.

Detailed description

Study Visit One: During an initial visit, subjects will complete the informed consent process, be instructed on the requirements of the study, and practice the exercise protocol (see below). Study Visit Two: Subjects will be tested after they have avoided exercise, caffeine, alcohol, chewing gum, and foods high in nitrate (e.g., spinach, beets, collard greens) for at least 24 hours. They will also be asked to not use any mouthwash products during this period. They will then provide provide a saliva sample for subsequent measurement of nitrate and nitrite concentrations and have their breath nitric oxide levels measured using a portable analyzer. The maximal knee extensor speed and power of their knee extensor muscles will then be measured using an isokinetic dynamometer. This machine can control the speed of movement while measuring the maximal force (torque) that a subject can voluntarily produce. Subjects will then be randomly assigned to receive either an antibacterial mouthwash (Cepacol©, Reckitt Benckiser, Parsippany, NJ) or, as a control solution, an alcohol-free natural mouthwash (Tom's of Maine©, Kennebunk, ME). Participants will be asked to rinse their mouth as directed on the product's packaging for 30 s twice per day for 7 (+/-2) days and to record the usage of the mouthwash on a provided form. Subjects will then return for Study Visit 3 (see below). This is considered a single-blind study, which means that the investigators will not know what type of mouthwash a subject is receives. Study Visit Three: At the end of the treatment period, subjects will be asked to return to undergo the same procedures as described for Study Visit Two.

Interventions

DEVICECepacol

Twice-daily use of Cepacol per the manufacturer's guidelines

DEVICETom's Natural Mouthwash

Twice-daily use of Tom's Natural Mouthwash per the manufacturer's guidelines

Sponsors

Indiana University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

Inclusion criteria

Inclusion: * Men and Women age 18-30 years old * No current use of mouthwash Exclusion: * Men and Women \<18 or 30\> y of age * Unable to provide informed consent * Current users of mouthwash * Current antibiotic use * Current smokers * Currently pregnant or lactating * Stage II hypertension (resting blood pressure \>140/\>90) An answer of yes to any of the seven questions on the first page of the Physical Activity Readiness Questionnaire (PAR-Q) indicating that the subject is not physically ready for exercise without a medical exam. These exclusions include the following: * If participant's doctor has ever said that he/she has a heart condition and that he/she should only do physical activity recommended by a doctor * Pain in chest when doing physical activity * In past month, chest pain when not doing physical activity * If participant has ever lost balance because of dizziness or has ever lost consciousness * Bone or joint problem that could be made worse by change in physical activity * Currently on prescribed drugs for blood pressure or heart condition. * If the participant knows of any other reason why he/she should not do physical activity.

Design outcomes

Primary

MeasureTime frameDescription
Muscle Function1 dayMaximal knee extensor speed determined using isokinetic dynamometry

Secondary

MeasureTime frameDescription
Salivary Nitrate1 daySalivary concentration of nitrate
Salivary Nitrite7 daySalivary concentration of nitrite
Breath Nitric Oxide1 dayBreath nitric oxide level

Countries

United States

Participant flow

Participants by arm

ArmCount
Cepacol
Cepacol: Twice-daily use of Cepacol per the manufacturer's guidelines
15
Tom's Natural Mouthwash
Tom's Natural Mouthwash: Twice-daily use of Tom's Natural Mouthwash per the manufacturer's guidelines
15
Total30

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up01
Overall StudyScreen failure10

Baseline characteristics

CharacteristicTom's Natural MouthwashTotalCepacol
Age, Continuous23 years
STANDARD_DEVIATION 3
22 years
STANDARD_DEVIATION 3
22 years
STANDARD_DEVIATION 4
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
15 Participants30 Participants15 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race and Ethnicity Not Collected0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
15 Participants30 Participants15 Participants
Region of Enrollment
United States
15 participants26 participants15 participants
Sex: Female, Male
Female
7 Participants12 Participants5 Participants
Sex: Female, Male
Male
8 Participants18 Participants10 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 130 / 13
other
Total, other adverse events
0 / 150 / 15
serious
Total, serious adverse events
0 / 130 / 13

Outcome results

Primary

Muscle Function

Maximal knee extensor speed determined using isokinetic dynamometry

Time frame: 1 day

ArmMeasureValue (MEAN)Dispersion
CepacolMuscle Function11.0 rad/sStandard Deviation 2.2
Tom's Natural MouthwashMuscle Function13.1 rad/sStandard Deviation 2.5
Primary

Muscle Function

Maximal knee extensor speed determined using isokinetic dynamometry

Time frame: 7 day

ArmMeasureValue (MEAN)Dispersion
CepacolMuscle Function13.3 rad/sStandard Deviation 3
Tom's Natural MouthwashMuscle Function13.6 rad/sStandard Deviation 2.8
Secondary

Breath Nitric Oxide

Breath nitric oxide level

Time frame: 1 day

ArmMeasureValue (MEAN)Dispersion
CepacolBreath Nitric Oxide17 ppmStandard Deviation 10
Tom's Natural MouthwashBreath Nitric Oxide20 ppmStandard Deviation 9
Secondary

Breath Nitric Oxide

Breath nitric oxide level

Time frame: 7 day

ArmMeasureValue (MEAN)Dispersion
CepacolBreath Nitric Oxide17 ppmStandard Deviation 7
Tom's Natural MouthwashBreath Nitric Oxide20 ppmStandard Deviation 10
Secondary

Salivary Nitrate

Salivary concentration of nitrate

Time frame: 1 day

ArmMeasureValue (MEAN)Dispersion
CepacolSalivary Nitrate407 umol/LStandard Deviation 229
Tom's Natural MouthwashSalivary Nitrate595 umol/LStandard Deviation 359
Secondary

Salivary Nitrite

Salivary concentration of nitrite

Time frame: 7 day

ArmMeasureValue (MEAN)Dispersion
CepacolSalivary Nitrite602 umol/LStandard Deviation 490
Tom's Natural MouthwashSalivary Nitrite533 umol/LStandard Deviation 310

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026