Exploring the links between oral bacteria, muscle blood flow, and fitness levels
Associations Between the Microbiome, Skeletal Muscle Perfusion, and Fitness Status
This study is trying to see how oral bacteria and fitness levels affect blood flow to muscles in people.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Virginia Academic / other |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT06009276 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the relationships between fitness status, oral microbiome bacteria, and blood flow to skeletal muscles. Participants will undergo various assessments, including mouth swabs, saliva samples, maximum effort cycling, blood draws, and ultrasound tests to measure muscle blood flow. The study seeks to understand how fitness levels may influence oral bacteria and the body's ability to deliver blood to muscles, particularly in the context of cardiovascular health.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who can communicate effectively and provide informed consent.
Not a fit: Patients with chronic renal failure, those using certain medications, or individuals with poor oral health may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how improving fitness may enhance cardiovascular health by influencing oral bacteria and muscle perfusion.
How similar studies have performed: While the specific associations being studied may be novel, previous research has indicated potential benefits of oral nitrate supplementation on cardiovascular health.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent. * Subjects may be of either sex with age 18 years. Exclusion Criteria: * Oral antibiotic use within previous four weeks * Oral disease or poor oral health as determined by the Oral Health Questionnaire * Using an antibacterial mouthwash or a mouthwash containing chlorhexidine and unwilling to discontinue use * Tobacco smokers * Pregnant or lactating females * Hypersensitivity to any ultrasound contrast agent * Inability to perform exercise * Unable to communicate effectively in English to the study team. * Diagnosis of chronic renal failure (GFR \< 60 ml/min/1.73m) * Subjects taking nitroglycerine (or inorganic nitrates), PDE-5 inhibitors (ex: Cialis, Viagra), and xanthine oxidase inhibitors (ex: Allopurinol).
Where this trial is running
Charlottesville, Virginia
- UVA Student Health and Wellness Building — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Jason D Allen, PhD — University of Virginia
- Study coordinator: Casey C Derella, PhD
- Email: bxg7vn@virginia.edu
- Phone: 6092476377
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.