Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT06009276

Recruiting nowNot applicableObservational

What this study is about

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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot listed

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

Full registry 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).

Treatments and study arms

The registry does not list a named intervention.

Primary outcomes

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

UVA Student Health and Wellness Building🇺🇸 Charlottesville, Virginia, United States

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Jason D Allen, PhDContact

Email · Call 434-243-3508