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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Virginia

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial 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).

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

70 Participants
are grouped into 3 trial groups
Group A: Heart Failure
Group B: Peripheral Artery Disease
Group C: Healthy Controls

Trial outcomes

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.

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

Secondary outcomes

1

Aerobic Capacity

Peak aerobic capacity (VO2peak) will be assessed using a symptom-limited graded exercise test on a cycle ergometer.

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

Other outcomes

1

Peripheral and Central Blood Pressures

Brachial artery blood pressures will be obtained using a standard sphygmomanometer. Aortic blood pressures will be obtained using applanation tonometry (SphygmoCor version 8.0, AtCor Medical).

Time frame
Baseline, 4-weeks, 12-weeks, 6-months
2

24-hour ambulatory blood pressure

Blood pressure will be monitored using a standard ambulatory brachial artery blood pressure cuff (SunTech Oscar 2, SunTech Medical). Blood pressure measurements are programmed to be taken every 30-minutes during the day and every hour at night. This allows for monitoring of nighttime blood pressure changes and variations throughout the day.

Time frame
Baseline, 4-weeks, 12-weeks, 6-months
3

Flow-Mediated Dilation

Participants will be placed in a supine position with their left forearm slightly extended and supinated with legs straight. The arteries will be imaged using a high-resolution 7.5MHz linear array transducer at rest, during 5 minutes of forearm occlusion via cuff inflation, and continuously for 3 minutes post-occlusion; an EKG trigger will be used to capture images during end-diastole of the cardiac cycle.

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

Serum Glucose

A blood sample will be obtained to measure serum glucose.

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

Sponsors and contacts

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