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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04095442
Recruitment Status : Suspended (COVID-19 pandemic)
First Posted : September 19, 2019
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Andrew R. Coggan, 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.

Condition or disease Intervention/treatment Phase
Quadriceps Muscle Drug: Cepacol Drug: Tom's Natural Mouthwash Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: Effect of Antibacterial Mouthwash on Muscle Function in Healthy Young Men and Women
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Active Comparator: Cepacol Drug: Cepacol
Twice-daily use of Cepacol per the manufacturer's guidelines

Sham Comparator: Tom's Natural Mouthwash Drug: Tom's Natural Mouthwash
Twice-daily use of Tom's Natural Mouthwash per the manufacturer's guidelines




Primary Outcome Measures :
  1. Muscle function [ Time Frame: 1 day ]
    Maximal knee extensor speed and power determined using isokinetic dynamometry

  2. Muscle function [ Time Frame: 7 day ]
    Maximal knee extensor speed and power determined using isokinetic dynamometry


Secondary Outcome Measures :
  1. Salivary nitrate/nitrite [ Time Frame: 1 day ]
    Salivary concentrations of nitrate and nitrite

  2. Salivary nitrate/nitrite [ Time Frame: 7 day ]
    Salivary concentrations of nitrate and nitrite

  3. Breath nitric oxide [ Time Frame: 1 day ]
    Breath nitric oxide level

  4. Breath nitric oxide [ Time Frame: 7 day ]
    Breath nitric oxide level



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04095442


Locations
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United States, Indiana
Indiana University School of Health and Human Sciences
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
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Responsible Party: Andrew R. Coggan, Associate Professor, Indiana University
ClinicalTrials.gov Identifier: NCT04095442    
Other Study ID Numbers: 1907204336
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Andrew R. Coggan, Indiana University:
muscle power
nitric oxide
muscle speed
oral microbiome
Additional relevant MeSH terms:
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Benzocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents