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 volunteersQualifiers
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
Case-control
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Aerobic Capacity
Peak aerobic capacity (VO2peak) will be assessed using a symptom-limited graded exercise test on a cycle ergometer.
Other outcomes
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).
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.
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.
Serum Glucose
A blood sample will be obtained to measure serum glucose.
Sponsors and contacts
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