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

Not Applicable

Completed

• Conditions: Quadriceps Muscle
• Interventions: Device: Tom's Natural Mouthwash; Device: Cepacol

• Registration Number: NCT04095442
• Lead Sponsor: Indiana University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-09-16
• Study First Submitted QC: 2019-09-17
• Study First Posted: 2019-09-19
• Study Start: 2019-11-01
• Primary Completion: 2023-03-20
• Study Completion: 2023-03-20
• Status Verified: 2024-02
• Results First Submitted: 2024-02-18
• Results First Submitted QC: 2024-02-18
• Last Update Submitted: 2024-02-18
• Results First Posted: 2024-03-18
• Last Update Posted: 2024-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tom's Natural Mouthwash	Tom's Natural Mouthwash	-
Cepacol	Cepacol	-

Primary Outcome Measures

Name	Time	Method
Muscle Function	7 day	Maximal knee extensor speed determined using isokinetic dynamometry

Secondary Outcome Measures

Name	Time	Method
Salivary Nitrate	1 day	Salivary concentration of nitrate
Salivary Nitrite	7 day	Salivary concentration of nitrite
Breath Nitric Oxide	7 day	Breath nitric oxide level

Trial Locations

Locations (1)

Indiana University School of Health and Human Sciences; 🇺🇸 Indianapolis, Indiana, United States