Studies how fitness relates to mouth bacteria and muscle blood flow
Looks at how fitness, mouth bacteria and blood flow to muscle are linked in adults.
Key facts
- Who runs it
- University of Virginia
- Where
- Charlottesville, United StatesSee the site
- Trial code
- Registry title
- Associations Between the Microbiome, Skeletal Muscle Perfusion, and Fitness Status
- Status
- Recruiting
- People taking part
- 70 people, planned
- Started
- 30 Aug 2023
- Expected to end
- Dec 2026
- Type of study
- Observational, 3 groups
- Record updated
- 24 December 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults of any sex who can give written consent and take part in tests of fitness, mouth bacteria and muscle blood flow.
- Age
- 18 years or older
- Sex
- Both sexes can join
- Earlier treatment
- People must not have used oral antibiotics in the previous four weeks.
Main reasons for not taking part
- Oral antibiotics in the previous four weeks
- Oral disease or poor oral health
- Tobacco smokers
- Pregnant or breastfeeding women
- Chronic renal failure (GFR < 60 ml/min/1.73m)
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- Oral antibiotic use within previous four weeks
- Subjects taking nitroglycerine (or inorganic nitrates), PDE-5 inhibitors (ex: Cialis, Viagra), and xanthine oxidase inhibitors (ex: Allopurinol)
- Oral disease or poor oral health as determined by the Oral Health Questionnaire
- Hypersensitivity to any ultrasound contrast agent
- Diagnosis of chronic renal failure (GFR < 60 ml/min/1.73m)
- Using an antibacterial mouthwash or a mouthwash containing chlorhexidine and unwilling to discontinue use
- Tobacco smokers
- Pregnant or lactating females
- Inability to perform exercise
- Unable to communicate effectively in English to the study team
Where in United States
- UVA Student Health and Wellness BuildingCharlottesville, United StatesContact: Jason D Allen, PhDTaking people
About the trial
What the trial wants to find out
The purpose of the study is to determine associations between fitness status, bacteria in the mouth, and the blood flow to muscle. This study is trying to find out if fitness status impacts the bacteria that are present in the oral microbiome (environment in the mouth) or the ability of the body to send blood to the skeletal muscle.
Read full original descriptionShow less
Participants will complete all or some of the following:
* A mouth swab to assess the bacteria in their mouths. * Produce a saliva sample into a tube. * Cycle on a bike until you reach maximum effort. * Undergo blood draws * Wear a 24-hour non-invasive device that monitors blood pressure. * Drink 70mL (1/3 of a cup) of concentrated beetroot juice once
The 3 groups in the trial
- Heart Failure
Patients diagnosed with Heart Failure (HFrEF and HFpEF). Oral microbiome will be analyzed through tongue swabs, saliva samples, and a saliva rinse. Patients will undergo a maximal exercise test, blood draws, and vascular testing. Patients will have the option to participate in a supplementation assessment with concentrated beetroot juice.
- Peripheral Artery Disease
Patients diagnosed with Peripheral Artery Disease (PAD). Oral microbiome will be analyzed through tongue swabs, saliva samples, and a saliva rinse. Patients will undergo a maximal exercise test, blood draws, and vascular testing. Patients will have the option to participate in a supplementation assessment with concentrated beetroot juice.
- Healthy Controls
Individuals that are not diagnosed with cardiovascular disease. Oral microbiome will be analyzed through tongue swabs, saliva samples, and a saliva rinse. Patients will undergo a maximal exercise test, blood draws, and vascular testing. Patients will have the option to participate in a supplementation assessment with concentrated beetroot juice.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Associations Between the Microbiome, Skeletal Muscle Perfusion, and Fitness Status
- Plain-language title
- Studies how fitness relates to mouth bacteria and muscle blood flowGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 24 December 2025