Recruiting

Observational Study

Sponsor:

University of Virginia

Code:

NCT06009276

Conditions

Heart Failure, Systolic

Heart Failure, Diastolic

Peripheral Arterial Disease

Overweight and Obesity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Conditions

Heart Failure, Systolic

Heart Failure, Diastolic

Peripheral Arterial Disease

Overweight and Obesity

Study ID

NCT06009276

Start date

Aug 30, 2023

Status verified date

Dec, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

70 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Oral Nitrate Reducing Capacity [ Time Frame: Baseline, 4-weeks, 12-weeks, 6-months ]

Central Contacts and Locations

Central contacts

Casey C Derella, PhD

6092476377bxg7vn@virginia.edu

Macy E Stahl, B.S.E.d

5719698323mes4hm@virginia.edu

Locations

UVA Student Health and Wellness Building

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Jason D Allen, PhD

434-243-3508ja6af@virginia.edu

More Information

Sponsor

University of Virginia

Last update posted

Dec 24, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2025-12-24.