Quadriceps Muscle
Conditions
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
Twice-daily use of Cepacol per the manufacturer's guidelines
Twice-daily use of Tom's Natural Mouthwash per the manufacturer's guidelines
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Muscle Function | 1 day | Maximal knee extensor speed determined using isokinetic dynamometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Salivary Nitrate | 1 day | Salivary concentration of nitrate |
| Salivary Nitrite | 7 day | Salivary concentration of nitrite |
| Breath Nitric Oxide | 1 day | Breath nitric oxide level |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Screen failure | 1 | 0 |
Baseline characteristics
| Characteristic | Tom's Natural Mouthwash | Total | Cepacol |
|---|---|---|---|
| Age, Continuous | 23 years STANDARD_DEVIATION 3 | 22 years STANDARD_DEVIATION 3 | 22 years STANDARD_DEVIATION 4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 30 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 30 Participants | 15 Participants |
| Region of Enrollment United States | 15 participants | 26 participants | 15 participants |
| Sex: Female, Male Female | 7 Participants | 12 Participants | 5 Participants |
| Sex: Female, Male Male | 8 Participants | 18 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 13 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 |
Outcome results
Muscle Function
Maximal knee extensor speed determined using isokinetic dynamometry
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cepacol | Muscle Function | 11.0 rad/s | Standard Deviation 2.2 |
| Tom's Natural Mouthwash | Muscle Function | 13.1 rad/s | Standard Deviation 2.5 |
Muscle Function
Maximal knee extensor speed determined using isokinetic dynamometry
Time frame: 7 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cepacol | Muscle Function | 13.3 rad/s | Standard Deviation 3 |
| Tom's Natural Mouthwash | Muscle Function | 13.6 rad/s | Standard Deviation 2.8 |
Breath Nitric Oxide
Breath nitric oxide level
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cepacol | Breath Nitric Oxide | 17 ppm | Standard Deviation 10 |
| Tom's Natural Mouthwash | Breath Nitric Oxide | 20 ppm | Standard Deviation 9 |
Breath Nitric Oxide
Breath nitric oxide level
Time frame: 7 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cepacol | Breath Nitric Oxide | 17 ppm | Standard Deviation 7 |
| Tom's Natural Mouthwash | Breath Nitric Oxide | 20 ppm | Standard Deviation 10 |
Salivary Nitrate
Salivary concentration of nitrate
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cepacol | Salivary Nitrate | 407 umol/L | Standard Deviation 229 |
| Tom's Natural Mouthwash | Salivary Nitrate | 595 umol/L | Standard Deviation 359 |
Salivary Nitrite
Salivary concentration of nitrite
Time frame: 7 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cepacol | Salivary Nitrite | 602 umol/L | Standard Deviation 490 |
| Tom's Natural Mouthwash | Salivary Nitrite | 533 umol/L | Standard Deviation 310 |