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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cepacol | Active Comparator |
| |
| Tom's Natural Mouthwash | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cepacol | Device | Twice-daily use of Cepacol per the manufacturer's guidelines |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle Function | Maximal knee extensor speed determined using isokinetic dynamometry | 1 day |
| Muscle Function | Maximal knee extensor speed determined using isokinetic dynamometry | 7 day |
| Measure | Description | Time Frame |
|---|---|---|
| Salivary Nitrate | Salivary concentration of nitrate | 1 day |
| Salivary Nitrite | Salivary concentration of nitrite | 7 day |
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Inclusion:
Exclusion:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University School of Health and Human Sciences | Indianapolis | Indiana | 46202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cepacol | Cepacol: Twice-daily use of Cepacol per the manufacturer's guidelines |
| FG001 | Tom's Natural Mouthwash | Tom's Natural Mouthwash: Twice-daily use of Tom's Natural Mouthwash per the manufacturer's guidelines |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cepacol | Cepacol: Twice-daily use of Cepacol per the manufacturer's guidelines |
| BG001 | Tom's Natural Mouthwash | Tom's Natural Mouthwash: Twice-daily use of Tom's Natural Mouthwash per the manufacturer's guidelines |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Muscle Function | Maximal knee extensor speed determined using isokinetic dynamometry | Posted | Mean | Standard Deviation | rad/s | 1 day |
|
|
1 week
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cepacol | Cepacol: Twice-daily use of Cepacol per the manufacturer's guidelines |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew R. Coggan | Indiana University Indianapolis | 3172740656 | acoggan@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 12, 2022 | Feb 18, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 12, 2022 | Feb 18, 2024 | ICF_001.pdf |
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| Tom's Natural Mouthwash |
| Device |
Twice-daily use of Tom's Natural Mouthwash per the manufacturer's guidelines |
|
| Breath Nitric Oxide | Breath nitric oxide level | 1 day |
| Breath Nitric Oxide | Breath nitric oxide level | 7 day |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Primary | Muscle Function | Maximal knee extensor speed determined using isokinetic dynamometry | Posted | Mean | Standard Deviation | rad/s | 7 day |
|
|
|
| Secondary | Salivary Nitrate | Salivary concentration of nitrate | Posted | Mean | Standard Deviation | umol/L | 1 day |
|
|
|
| Secondary | Salivary Nitrite | Salivary concentration of nitrite | Posted | Mean | Standard Deviation | umol/L | 7 day |
|
|
|
| Secondary | Breath Nitric Oxide | Breath nitric oxide level | Posted | Mean | Standard Deviation | ppm | 1 day |
|
|
|
| Secondary | Breath Nitric Oxide | Breath nitric oxide level | Posted | Mean | Standard Deviation | ppm | 7 day |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 15 |
| EG001 | Tom's Natural Mouthwash | Tom's Natural Mouthwash: Twice-daily use of Tom's Natural Mouthwash per the manufacturer's guidelines | 0 | 13 | 0 | 13 | 0 | 15 |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|