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

Status: Recruiting
Location: See location...
Study Type: Observational
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. * Undergo a test to assess blood flow to the muscles measured with an ultrasound. * Drink 70mL (1/3 of a cup) of concentrated beetroot juice once

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:

• 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.

Locations
United States
Virginia
UVA Student Health and Wellness Building
RECRUITING
Charlottesville
Contact Information
Primary
Casey C Derella, PhD
bxg7vn@virginia.edu
6092476377
Backup
Macy E Stahl, B.S.E.d
mes4hm@virginia.edu
5719698323
Time Frame
Start Date: 2023-08-30
Estimated Completion Date: 2024-08-07
Participants
Target number of participants: 70
Treatments
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.
Sponsors
Leads: University of Virginia

This content was sourced from clinicaltrials.gov

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