NCT06009276 Associations Between the Microbiome, Skeletal Muscle Perfusion, and Fitness Status
| NCT ID | NCT06009276 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Virginia |
| Condition | Heart Failure, Systolic |
| Study Type | OBSERVATIONAL |
| Enrollment | 70 participants |
| Start Date | 2023-08-30 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 70 participants in total. It began in 2023-08-30 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility 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).
Contact & Investigator
Jason D Allen, PhD
PRINCIPAL INVESTIGATOR
University of Virginia
Frequently Asked Questions
Who can join the NCT06009276 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure, Systolic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06009276 currently recruiting?
Yes, NCT06009276 is actively recruiting participants. Contact the research team at bxg7vn@virginia.edu for enrollment information.
Where is the NCT06009276 trial being conducted?
This trial is being conducted at Charlottesville, United States.
Who is sponsoring the NCT06009276 clinical trial?
NCT06009276 is sponsored by University of Virginia. The principal investigator is Jason D Allen, PhD at University of Virginia. The trial plans to enroll 70 participants.
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