Actively Recruiting
Associations Between the Microbiome, Skeletal Muscle Perfusion, and Fitness Status
Led by University of Virginia · Updated on 2025-12-24
70
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to explore how fitness levels relate to the types of bacteria found in the mouth and the body's ability to send blood to skeletal muscles. The study focuses on people with varying heart and blood vessel health, including those with heart failure, peripheral artery disease, and healthy individuals. It investigates how oral bacteria help convert dietary nitrate into nitric oxide, a molecule important for heart and metabolic health, and how this impacts blood flow and exercise capacity. Participants will provide mouth swabs, saliva samples, and perform a cycling exercise test to maximum effort. They will also have blood draws and wear a 24-hour device that monitors blood pressure. Some participants may choose to drink a small amount of concentrated beetroot juice, which contains nitrate, to study its effect on nitric oxide production. This observational study collects data at baseline and follow-up time points up to six months. Throughout the study, researchers will assess the diversity and amount of nitrate-reducing bacteria in the mouth, measure nitrate-to-nitrite conversion in saliva and blood, and evaluate aerobic fitness. Participants will undergo vascular testing and complete questionnaires about oral health. The study includes multiple visits over several months to track changes, with safety and communication ensured. The goal is to better understand how oral bacteria and nitric oxide relate to cardiovascular health and exercise ability.
CONDITIONS
Brief Title
Associations Between the Microbiome, Skeletal Muscle Perfusion, and Fitness Status
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 or older.
You will not qualify if you...
- 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).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants undergo oral microbiome analysis, maximal exercise tests, blood draws, and vascular testing to assess nitrate reducing capacity and aerobic fitness over time.
Visits at Baseline, 4 weeks, 12 weeks, and 6 months
Trial Site Locations
Total: 1 location
1
UVA Student Health and Wellness Building
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
C
Casey C Derella, PhD
M
Macy E Stahl, B.S.E.d
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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