xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06009276</url>
    </required_header>
    <id_info>
      <org_study_id>HSR230229</org_study_id>
      <nct_id>NCT06009276</nct_id>
    </id_info>
    <brief_title>Associations Between the Microbiome, Skeletal Muscle Perfusion, and Fitness Status</brief_title>
    <official_title>Associations Between the Microbiome, Skeletal Muscle Perfusion, and Fitness Status</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Virginia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Virginia</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of the study is to determine associations between fitness status, bacteria in the&#xD;
        mouth, and the blood flow to muscle. This study is trying to find out if fitness status&#xD;
        impacts the bacteria that are present in the oral microbiome (environment in the mouth) or&#xD;
        the ability of the body to send blood to the skeletal muscle.&#xD;
  &#xD;
        Participants will complete all or some of the following:&#xD;
  &#xD;
          -  A mouth swab to assess the bacteria in their mouths.&#xD;
  &#xD;
          -  Produce a saliva sample into a tube.&#xD;
  &#xD;
          -  Cycle on a bike until you reach maximum effort.&#xD;
  &#xD;
          -  Undergo blood draws&#xD;
  &#xD;
          -  Wear a 24-hour non-invasive device that monitors blood pressure.&#xD;
  &#xD;
          -  Undergo a test to assess blood flow to the muscles measured with an ultrasound.&#xD;
  &#xD;
          -  Drink 70mL (1/3 of a cup) of concentrated beetroot juice once&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in the United&#xD;
        States. Nitric oxide (NO) is a gaseous diatomic free-radical and is essential for a plethora&#xD;
        of physiological functions involved in cardiometabolic health and CVD risk. NO&#xD;
        bioavailability is associated with greater tissue perfusion, mitochondrial function, glucose&#xD;
        regulation, and overall reduced CVD risk. The primary source of circulating NO is vascular&#xD;
        endothelial nitric oxide synthase.&#xD;
  &#xD;
        Unfortunately, the endothelium can be disrupted/damaged via a variety of CVD risk factors&#xD;
        such as hypertension, smoking, hyperlipidemia, diabetes, inflammation, and&#xD;
        hypercholesteremia. Disruption of the vascular endothelium and loss of bioavailable NO is a&#xD;
        preliminary step in the progression of atherosclerosis and CVD. Decreased NO bioavailability&#xD;
        and vascular dysfunction have been shown in a variety of clinical conditions including&#xD;
        patients heart failure and peripheral artery disease (PAD).&#xD;
  &#xD;
        Recently, an exogenous approach to increasing NO bioavailability via oral supplementation of&#xD;
        inorganic nitrate (NO3-) has been utilized to increase NO bioavailability in various healthy&#xD;
        and clinical populations. Briefly, inorganic NO3- is swallowed, absorbed into the&#xD;
        circulation, and sequestered back into the salivary glands. NO3- is then secreted into the&#xD;
        oral cavity, where bacteria containing nitrate reductase enzymes convert NO3- to nitrite&#xD;
        (NO2-), which is again swallowed and absorbed into the circulation. NO2- in the plasma is&#xD;
        then easily reduced to NO via non-enzymatic reactions.&#xD;
  &#xD;
        This study aims to better elucidate the relationship between the oral microbiome abundance&#xD;
        and diversity and NO3- to NO2- to NO conversion across a variety of subject populations&#xD;
        ranging from healthy subjects to those with risk factors for CVD and people with diagnosed&#xD;
        CVD. We also aim to examine the relationship between oral microbiome NO3- reduction and&#xD;
        impaired skeletal muscle perfusion and exercise capacity as NO bioavailability plays a large&#xD;
        role in these physiological processes.&#xD;
  &#xD;
        The results of this study may allow us to better understand how novel interventions to modify&#xD;
        the oral microbiome may improve cardiometabolic health and physical function in individuals&#xD;
        with CVD and outline potential new therapeutic approaches.&#xD;
  &#xD;
        The primary objective of this preliminary study is to compare the abundance and diversity of&#xD;
        oral NO3- reducing bacteria in a variety of subjects with varying cardiometabolic health&#xD;
        status and their ability to convert oral inorganic nitrate to nitrite measured in the saliva&#xD;
        and plasma.&#xD;
  &#xD;
        A secondary objective is to determine associations between the abundance and diversity of&#xD;
        oral NO3- reducing bacteria and both skeletal muscle tissue perfusion during exercise and&#xD;
        exercise capacity. A tertiary objective is to determine the stability of these relationships&#xD;
        over time following lifestyle modifications (i.e., exercise, diet).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 30, 2023</start_date>
    <completion_date type="Anticipated">August 7, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 7, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Oral Nitrate Reducing Capacity</measure>
      <time_frame>Baseline, 4-weeks, 12-weeks, 6-months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Skeletal muscle perfusion</measure>
      <time_frame>Baseline, 4-weeks, 12-weeks, 6-months</time_frame>
      <description>An I.V. will be placed and contrast ultrasound measurement of skeletal muscle blood flow of the calf, quad, and forearm at rest will be performed by the PI or a research sonographer using continuous infusion of Definity (2.3 mL diluted to 30 mL infused 1.5 ml/min) at a mechanical index (peak negative acoustic pressure/[frequency]) of 0.15 (defined by the American Society of Echocardiography contrast guidelines as low power).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Aerobic Capacity</measure>
      <time_frame>Baseline, 4-weeks, 12-weeks, 6-months</time_frame>
      <description>Peak aerobic capacity (VO2peak) will be assessed using a symptom-limited graded exercise test on a cycle ergometer.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Peripheral and Central Blood Pressures</measure>
      <time_frame>Baseline, 4-weeks, 12-weeks, 6-months</time_frame>
      <description>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).</description>
    </other_outcome>
    <other_outcome>
      <measure>24-hour ambulatory blood pressure</measure>
      <time_frame>Baseline, 4-weeks, 12-weeks, 6-months</time_frame>
      <description>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.</description>
    </other_outcome>
    <other_outcome>
      <measure>Skeletal muscle microvascular perfusion (near-infra-red- spectroscopy)</measure>
      <time_frame>Baseline, 4-weeks, 12-weeks, 6-months</time_frame>
      <description>Tissue oxygenation will be captured noninvasively using non-invasive, near-infrared spectrometry (NIRS, PortaMon, Artinis Medical Systems B.V., The Netherlands) positioned on the gastrocnemius or vastus lateralis muscle.</description>
    </other_outcome>
    <other_outcome>
      <measure>Flow-Mediated Dilation</measure>
      <time_frame>Baseline, 4-weeks, 12-weeks, 6-months</time_frame>
      <description>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.</description>
    </other_outcome>
    <other_outcome>
      <measure>Serum Glucose</measure>
      <time_frame>Baseline, 4-weeks, 12-weeks, 6-months</time_frame>
      <description>A blood sample will be obtained to measure serum glucose.</description>
    </other_outcome>
    <other_outcome>
      <measure>Insulin</measure>
      <time_frame>Baseline, 4-weeks, 12-weeks, 6-months</time_frame>
      <description>A blood sample will be obtained to measure insulin.</description>
    </other_outcome>
    <other_outcome>
      <measure>Lipids</measure>
      <time_frame>Baseline, 4-weeks, 12-weeks, 6-months</time_frame>
      <description>A blood sample will be obtained to measure lipids.</description>
    </other_outcome>
    <other_outcome>
      <measure>Hemoglobin</measure>
      <time_frame>Baseline, 4-weeks, 12-weeks, 6-months</time_frame>
      <description>A blood sample will be obtained to measure hemoglobin.</description>
    </other_outcome>
    <other_outcome>
      <measure>Hematocrit</measure>
      <time_frame>Baseline, 4-weeks, 12-weeks, 6-months</time_frame>
      <description>A blood sample will be obtained to measure hematocrit.</description>
    </other_outcome>
    <other_outcome>
      <measure>Plasma Nitrate</measure>
      <time_frame>Baseline, 4-weeks, 12-weeks, 6-months</time_frame>
      <description>A fasting blood draw will be taken. Following the blood draw, the participant will take one dose of Beetroot juice. The participant will then return to the lab three hours later for a second blood draw to assess level of nitrate in the plasma.</description>
    </other_outcome>
    <other_outcome>
      <measure>Plasma Nitrite</measure>
      <time_frame>Baseline, 4-weeks, 12-weeks, 6-months</time_frame>
      <description>A fasting blood draw will be taken. Following the blood draw, the participant will take one dose of Beetroot juice. The participant will then return to the lab three hours later for a second blood draw to assess level of nitrite in the plasma.</description>
    </other_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Heart Failure, Systolic</condition>
    <condition>Heart Failure, Diastolic</condition>
    <condition>Peripheral Arterial Disease</condition>
    <condition>Overweight and Obesity</condition>
    <arm_group>
      <arm_group_label>Heart Failure</arm_group_label>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Peripheral Artery Disease</arm_group_label>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy Controls</arm_group_label>
      <description>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.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          The population will include healthy individuals over the age of 18 years of either sex, or&#xD;
          individuals with cardiovascular disease (heart failure, peripheral artery disease).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subjects must be able to communicate meaningfully with the investigator and must be&#xD;
               legally competent to provide written informed consent.&#xD;
  &#xD;
            -  Subjects may be of either sex with age 18 years.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Oral antibiotic use within previous four weeks&#xD;
  &#xD;
            -  Oral disease or poor oral health as determined by the Oral Health Questionnaire&#xD;
  &#xD;
            -  Using an antibacterial mouthwash or a mouthwash containing chlorhexidine and unwilling&#xD;
               to discontinue use&#xD;
  &#xD;
            -  Tobacco smokers&#xD;
  &#xD;
            -  Pregnant or lactating females&#xD;
  &#xD;
            -  Hypersensitivity to any ultrasound contrast agent&#xD;
  &#xD;
            -  Inability to perform exercise&#xD;
  &#xD;
            -  Unable to communicate effectively in English to the study team.&#xD;
  &#xD;
            -  Diagnosis of chronic renal failure (GFR &lt; 60 ml/min/1.73m)&#xD;
  &#xD;
            -  Subjects taking nitroglycerine (or inorganic nitrates), PDE-5 inhibitors (ex: Cialis,&#xD;
               Viagra), and xanthine oxidase inhibitors (ex: Allopurinol).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Jason D Allen, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Virginia</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Casey C Derella, PhD</last_name>
      <phone>6092476377</phone>
      <email>bxg7vn@virginia.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Macy E Stahl, B.S.E.d</last_name>
      <phone>5719698323</phone>
      <email>mes4hm@virginia.edu</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Virginia</investigator_affiliation>
      <investigator_full_name>Jason Allen</investigator_full_name>
      <investigator_title>Professor of Kinesiology</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Failure</mesh_term>
      <mesh_term>Peripheral Arterial Disease</mesh_term>
      <mesh_term>Peripheral Vascular Diseases</mesh_term>
      <mesh_term>Heart Failure, Systolic</mesh_term>
      <mesh_term>Heart Failure, Diastolic</mesh_term>
      <mesh_term>Overweight</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06009276
  org study id: HSR230229
  nct id: NCT06009276
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  
          -  Undergo a test to assess blood flow to the muscles measured with an ultrasound.
  
          -  Drink 70mL (1/3 of a cup) of concentrated beetroot juice once
  Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in the United
        States. Nitric oxide (NO) is a gaseous diatomic free-radical and is essential for a plethora
        of physiological functions involved in cardiometabolic health and CVD risk. NO
        bioavailability is associated with greater tissue perfusion, mitochondrial function, glucose
        regulation, and overall reduced CVD risk. The primary source of circulating NO is vascular
        endothelial nitric oxide synthase.
  
        Unfortunately, the endothelium can be disrupted/damaged via a variety of CVD risk factors
        such as hypertension, smoking, hyperlipidemia, diabetes, inflammation, and
        hypercholesteremia. Disruption of the vascular endothelium and loss of bioavailable NO is a
        preliminary step in the progression of atherosclerosis and CVD. Decreased NO bioavailability
        and vascular dysfunction have been shown in a variety of clinical conditions including
        patients heart failure and peripheral artery disease (PAD).
  
        Recently, an exogenous approach to increasing NO bioavailability via oral supplementation of
        inorganic nitrate (NO3-) has been utilized to increase NO bioavailability in various healthy
        and clinical populations. Briefly, inorganic NO3- is swallowed, absorbed into the
        circulation, and sequestered back into the salivary glands. NO3- is then secreted into the
        oral cavity, where bacteria containing nitrate reductase enzymes convert NO3- to nitrite
        (NO2-), which is again swallowed and absorbed into the circulation. NO2- in the plasma is
        then easily reduced to NO via non-enzymatic reactions.
  
        This study aims to better elucidate the relationship between the oral microbiome abundance
        and diversity and NO3- to NO2- to NO conversion across a variety of subject populations
        ranging from healthy subjects to those with risk factors for CVD and people with diagnosed
        CVD. We also aim to examine the relationship between oral microbiome NO3- reduction and
        impaired skeletal muscle perfusion and exercise capacity as NO bioavailability plays a large
        role in these physiological processes.
  
        The results of this study may allow us to better understand how novel interventions to modify
        the oral microbiome may improve cardiometabolic health and physical function in individuals
        with CVD and outline potential new therapeutic approaches.
  
        The primary objective of this preliminary study is to compare the abundance and diversity of
        oral NO3- reducing bacteria in a variety of subjects with varying cardiometabolic health
        status and their ability to convert oral inorganic nitrate to nitrite measured in the saliva
        and plasma.
  
        A secondary objective is to determine associations between the abundance and diversity of
        oral NO3- reducing bacteria and both skeletal muscle tissue perfusion during exercise and
        exercise capacity. A tertiary objective is to determine the stability of these relationships
        over time following lifestyle modifications (i.e., exercise, diet).
  observational model: Case-Control
  time perspective: Prospective
  measure: Oral Nitrate Reducing Capacity
  time frame: Baseline, 4-weeks, 12-weeks, 6-months
  description: 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.
  measure: Skeletal muscle perfusion
  time frame: Baseline, 4-weeks, 12-weeks, 6-months
  description: An I.V. will be placed and contrast ultrasound measurement of skeletal muscle blood flow of the calf, quad, and forearm at rest will be performed by the PI or a research sonographer using continuous infusion of Definity (2.3 mL diluted to 30 mL infused 1.5 ml/min) at a mechanical index (peak negative acoustic pressure/[frequency]) of 0.15 (defined by the American Society of Echocardiography contrast guidelines as low power).
  measure: Aerobic Capacity
  time frame: Baseline, 4-weeks, 12-weeks, 6-months
  description: Peak aerobic capacity (VO2peak) will be assessed using a symptom-limited graded exercise test on a cycle ergometer.
  measure: Peripheral and Central Blood Pressures
  time frame: Baseline, 4-weeks, 12-weeks, 6-months
  description: 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).
  measure: 24-hour ambulatory blood pressure
  time frame: Baseline, 4-weeks, 12-weeks, 6-months
  description: 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.
  measure: Skeletal muscle microvascular perfusion (near-infra-red- spectroscopy)
  time frame: Baseline, 4-weeks, 12-weeks, 6-months
  description: Tissue oxygenation will be captured noninvasively using non-invasive, near-infrared spectrometry (NIRS, PortaMon, Artinis Medical Systems B.V., The Netherlands) positioned on the gastrocnemius or vastus lateralis muscle.
  measure: Flow-Mediated Dilation
  time frame: Baseline, 4-weeks, 12-weeks, 6-months
  description: 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.
  measure: Serum Glucose
  time frame: Baseline, 4-weeks, 12-weeks, 6-months
  description: A blood sample will be obtained to measure serum glucose.
  measure: Insulin
  time frame: Baseline, 4-weeks, 12-weeks, 6-months
  description: A blood sample will be obtained to measure insulin.
  measure: Lipids
  time frame: Baseline, 4-weeks, 12-weeks, 6-months
  description: A blood sample will be obtained to measure lipids.
  measure: Hemoglobin
  time frame: Baseline, 4-weeks, 12-weeks, 6-months
  description: A blood sample will be obtained to measure hemoglobin.
  measure: Hematocrit
  time frame: Baseline, 4-weeks, 12-weeks, 6-months
  description: A blood sample will be obtained to measure hematocrit.
  measure: Plasma Nitrate
  time frame: Baseline, 4-weeks, 12-weeks, 6-months
  description: A fasting blood draw will be taken. Following the blood draw, the participant will take one dose of Beetroot juice. The participant will then return to the lab three hours later for a second blood draw to assess level of nitrate in the plasma.
  measure: Plasma Nitrite
  time frame: Baseline, 4-weeks, 12-weeks, 6-months
  description: A fasting blood draw will be taken. Following the blood draw, the participant will take one dose of Beetroot juice. The participant will then return to the lab three hours later for a second blood draw to assess level of nitrite in the plasma.
  arm group label: Heart Failure
  description: 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.
  arm group label: Peripheral Artery Disease
  description: 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.
  arm group label: Healthy Controls
  description: 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.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Jason D Allen, PhD
  role: Principal Investigator
  affiliation: University of Virginia
  last name: Casey C Derella, PhD
  phone: 6092476377
  email: bxg7vn@virginia.edu
  last name: Macy E Stahl, B.S.E.d
  phone: 5719698323
  email: mes4hm@virginia.edu
  responsible party type: Principal Investigator
  investigator affiliation: University of Virginia
  investigator full name: Jason Allen
  investigator title: Professor of Kinesiology
  mesh term: Heart Failure
  mesh term: Peripheral Arterial Disease
  mesh term: Peripheral Vascular Diseases
  mesh term: Heart Failure, Systolic
  mesh term: Heart Failure, Diastolic
  mesh term: Overweight
  sharing ipd: No