Associations Between the Microbiome, Skeletal Muscle Perfusion, and Fitness Status

Recruiting now

Conditions studied: Heart Failure, Systolic, Heart Failure, Diastolic, Peripheral Arterial Disease, Overweight and Obesity

In brief

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. 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

Key facts

Study ID

NCT06009276

Run by

University of Virginia

People needed

70

Starts

2023-08-30

Expected to finish

2026-12-01

Last updated by the study team

2025-12-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• UVA Student Health and Wellness Building — Charlottesville, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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