Quadriceps MuscleNCT04095442
Effect of Antibacterial Mouthwash on Muscle Function in Healthy Young Men and Women
A study testing Cepacol and Tom's Natural Mouthwash in people with Quadriceps Muscle, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Quadriceps Muscle
- What is being tested?
- Cepacol and Tom's Natural Mouthwash
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 20 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and Women age 18-30 years old
- No current use of mouthwash
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Health and Human Sciences
Indianapolis, Indiana, 46202
About this study
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.
Read the 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.
- Conditions
- Quadriceps Muscle
- Being tested
- Cepacol, Tom's Natural Mouthwash
- Keywords
- muscle power, nitric oxide, muscle speed, oral microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CepacolDevice
Twice-daily use of Cepacol per the manufacturer's guidelines
Tom's Natural MouthwashDevice
Twice-daily use of Tom's Natural Mouthwash per the manufacturer's guidelines
| Study group | Role | What they receive |
|---|---|---|
| Cepacol | Active comparator | Not described Receives: Device: Cepacol |
| Tom's Natural Mouthwash | Sham comparator | Not described Receives: Device: Tom's Natural Mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Function
Maximal knee extensor speed determined using isokinetic dynamometry
Measured: 1 day
Muscle Function
Maximal knee extensor speed determined using isokinetic dynamometry
Measured: 7 day
Secondary outcomes (4)
Salivary Nitrate
Salivary concentration of nitrate
Measured: 1 day
Salivary Nitrite
Salivary concentration of nitrite
Measured: 7 day
Breath Nitric Oxide
Breath nitric oxide level
Measured: 1 day
Breath Nitric Oxide
Breath nitric oxide level
Measured: 7 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start1 Nov 2019
- Primary completion20 Mar 2023
- Study completion20 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quadriceps MuscleStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Coggan, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095442
- Sponsor's protocol ID
- 1907204336
- Status last verified
- Feb 2024
- First submitted
- 16 Sep 2019
- Last updated
- 18 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Gallardo EJ, Zoughaib WS, Singhal A, Hoffman RL, Coggan AR. Pilot randomized trial of the effect of antibacterial mouthwash on muscle contractile function in healthy young adults. PLoS One. 2025 Feb 12;20(2):e0312961. doi: 10.1371/journal.pone.0312961. eCollection 2025.
PubMed 39937800
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Antibacterial Mouthwash on Muscle Function in Healthy Young Men and Women
- ClinicalTrials.gov ID
- NCT04095442
- Acronym / sponsor ID
- 1907204336
- Conditions
- Quadriceps Muscle
- Keywords
- muscle power, nitric oxide, muscle speed, oral microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 20 Mar 2023 (actual)
- First posted
- 19 Sep 2019 (actual)
- Results
- Posted 18 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cepacol | Active comparator | Device: Cepacol |
| Tom's Natural Mouthwash | Sham comparator | Device: Tom's Natural Mouthwash |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Men and Women age 18-30 years old
- No current use of mouthwash
Key exclusion criteria (15 listed)
- Men and Women <18 or 30> y of age
- Unable to provide informed consent
- Current users of mouthwash
- Current antibiotic use
- Current smokers
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 |
|---|---|---|
| CepacolTwice-daily use of Cepacol per the manufacturer's guidelines | Device | Cepacol |
| Tom's Natural MouthwashTwice-daily use of Tom's Natural Mouthwash per the manufacturer's guidelines | Device | Tom's Natural Mouthwash |
Primary outcome
Muscle Function
Time frame: 1 day
Maximal knee extensor speed determined using isokinetic dynamometry
Muscle Function
Time frame: 7 day
Maximal knee extensor speed determined using isokinetic dynamometry
4 secondary outcomes
Salivary Nitrate
Time frame: 1 day
Salivary Nitrite
Time frame: 7 day
Breath Nitric Oxide
Time frame: 1 day
Breath Nitric Oxide
Time frame: 7 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39937800Gallardo EJ, Zoughaib WS, Singhal A, Hoffman RL, Coggan AR. Pilot randomized trial of the effect of antibacterial mouthwash on muscle contractile function in healthy young adults. PLoS One. 2025 Feb 12;20(2):e0312961. doi: 10.1371/journal.pone.0312961. eCollection 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cepacol and Tom's Natural Mouthwash in people with Quadriceps Muscle, run by Indiana University at 1 site in United States.
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 2 inclusion and 15 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 18 Mar 2024. 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 United States. 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?
Yes. Results are posted in the registry (first posted 18 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Muscle Function (time frame: 1 day). The study lists 2 primary outcomes in all. 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 NCT04095442, 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 18 Mar 2024.