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Study on Microbiome, Muscle Blood Flow, and Fitness

This observational study is looking at the connections between your fitness level, the bacteria in your mouth (oral microbiome), and how well blood flows to your muscles. Researchers want to see if being fit affects the types of bacteria in your mouth or your body's ability to send blood to your skeletal muscles. This study involves people with heart failure (systolic or diastolic), peripheral arterial disease, or those who are overweight or obese. The main goal is to measure your oral nitrate reducing capacity (how well your mouth bacteria can turn nitrates into nitric oxide, which helps blood flow) at the beginning, 4 weeks, 12 weeks, and 6 months into the study. You can join if you are 18 or older, can communicate with the researchers, and haven't used oral antibiotics recently or have certain oral health issues.

Study design
This is an observational study with a planned enrollment of 70 participants. It is not a drug trial, but rather aims to understand natural associations.
What's involved
You may provide a mouth swab and saliva sample, cycle on a bike to maximum effort, have blood drawn, wear a 24-hour blood pressure monitor, and drink concentrated beetroot juice once.
Compensation
Not stated in the trial record.
Follow-up
Your oral nitrate reducing capacity will be measured at baseline, 4 weeks, 12 weeks, and 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06009276

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

Recruiting
Not specifiedAges 18+Observational
University of Virginia
~70 participants
Updated 2025-12-24 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Oral Nitrate Reducing Capacity
Measured over Baseline, 4-weeks, 12-weeks, 6-months

Conditions

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

Explore related trials

Heart FailureObesityPeripheral Artery Disease

Where it's being run

1 sites across 1 states
Virginia1

Study leadership

  • Jason D Allen, PhD · PRINCIPAL_INVESTIGATOR · University of Virginia

Who to contact

Casey C Derella, PhD
[email protected]
6092476377
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Oral Nitrate Reducing CapacityBaseline, 4-weeks, 12-weeks, 6-months

    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.