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

NCT04095442 | Completed Results DMC FDA Device

• 1 other identifier: 1907204336
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Quadriceps Muscle

Keywords

muscle power; nitric oxide; muscle speed; oral microbiome

Outcome Measures

Primary Outcomes (2)

• Muscle Function

  Maximal knee extensor speed determined using isokinetic dynamometry

  1 day

• Muscle Function

  Maximal knee extensor speed determined using isokinetic dynamometry

  7 day

Secondary Outcomes (4)

• Salivary Nitrate

  1 day

• Salivary Nitrite

  7 day

• Breath Nitric Oxide

  1 day

• Breath Nitric Oxide

  7 day

Study Arms (2)

Cepacol

ACTIVE COMPARATOR

Device: Cepacol

Tom's Natural Mouthwash

SHAM COMPARATOR

Device: Tom's Natural Mouthwash

Interventions

Cepacol DEVICE

Twice-daily use of Cepacol per the manufacturer's guidelines

Cepacol

Tom's Natural Mouthwash DEVICE

Twice-daily use of Tom's Natural Mouthwash per the manufacturer's guidelines

Tom's Natural Mouthwash

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and Women age 18-30 years old
• No current use of mouthwash

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University School of Health and Human Sciences

Indianapolis, Indiana, 46202, United States

Location

Results Point of Contact

• Title: Andrew R. Coggan
• Organization: Indiana University Indianapolis

acoggan@iu.edu

3172740656

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: September 19, 2019
• Study Start: November 1, 2019
• Primary Completion: March 20, 2023
• Study Completion: March 20, 2023
• Last Updated: March 18, 2024
• Results First Posted: March 18, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)