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

NCT06009276 | Recruiting

• 1 other identifier: HSR230229
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Oral Nitrate Reducing Capacity

  Assessment of the oral microbiome's ability to reduce nitrate to nitrite. This will be measured through a swab on the dorsal surface of the tongue, an unstimulated saliva sample, and a rinse of a standard nitrate solution.

  Baseline, 4-weeks, 12-weeks, 6-months

Secondary Outcomes (1)

• Aerobic Capacity

  Baseline, 4-weeks, 12-weeks, 6-months

Other Outcomes (10)

• Peripheral and Central Blood Pressures

  Baseline, 4-weeks, 12-weeks, 6-months

• 24-hour ambulatory blood pressure

  Baseline, 4-weeks, 12-weeks, 6-months

• Flow-Mediated Dilation

  Baseline, 4-weeks, 12-weeks, 6-months

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population will include healthy individuals over the age of 18 years of either sex, or individuals with cardiovascular disease (heart failure, peripheral artery disease).

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).

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

UVA Student Health and Wellness Building

Charlottesville, Virginia, 22903, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure, Systolic; Heart Failure, Diastolic; Peripheral Arterial Disease; Overweight; Obesity

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Peripheral Vascular Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jason D Allen, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Casey C Derella, PhD

CONTACT

6092476377; bxg7vn@virginia.edu

Macy E Stahl, B.S.E.d

CONTACT

5719698323; mes4hm@virginia.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Kinesiology

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: August 24, 2023
• Study Start: August 30, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)