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/NCT06018480</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00003857</org_study_id>
      <nct_id>NCT06018480</nct_id>
    </id_info>
    <brief_title>The Effect of NADPH Oxidase and Creatine Supplementation on Microvascular Blood Flow Regulation</brief_title>
    <acronym>NOXCROS</acronym>
    <official_title>NADPH Oxidase Affects on Blood Flow After Administering a High Carbohydrate Meal Pre- and Post-creatine Monohydrate Supplementation.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Florida State University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Florida State University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This research study seeks to determine the effects of an enzyme in the human body called&#xD;
        NADPH oxidase (NOX) on blood flow. In addition, the study will investigate the benefits of&#xD;
        creatine monohydrate, a common sports performance supplement, on blood food and vessel&#xD;
        function. Participants will undergo two study arms, one in which they consume a high&#xD;
        carbohydrate meal pre- and post-creatine monohydrate supplementation and one in which they&#xD;
        will consume a high carbohydrate meal pre- and post-placebo supplementation. Blood flow and&#xD;
        endothelial function will be assessed before and for 4 hours following the consumption of a&#xD;
        high-carbohydrate meal pre and post-supplementation (creatine monohydrate and placebo).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A double-blind cross-over placebo-controlled study design will be used to determine the&#xD;
        extent to which NOX and creatine monohydrate supplementation influences skeletal muscle&#xD;
        microvascular blood flow and endothelial function following the administration of a high&#xD;
        carbohydrate meal in sedentary individuals with overweight/obesity. Participants will be&#xD;
        initially screened through a telephone screening over the phone or through an electronic copy&#xD;
        (Qualtrics survey) and upon meeting the inclusion criteria, will be scheduled for a baseline&#xD;
        visit. At the baseline visits participants will go through an informed consent, background&#xD;
        and medical history questionnaire alongside a DXA scan and indirect calorimetry.&#xD;
        Subsequently, participants will undergo two main testing days, one will occur before&#xD;
        supplementation (creatine monohydrate or placebo) and the other following five days of&#xD;
        supplementation (creatine monohydrate or placebo). At the main testing days participants will&#xD;
        have their resting blood flow and endothelial function assessed before and for 4 hours&#xD;
        following the consumption of a high carbohydrate meal. Following the two main testing days in&#xD;
        the first study arm, participants will then undergo a 4-week wash-out in which they will&#xD;
        resume their normal behavior and stop taking the supplement they were provided. After the&#xD;
        washout period, participants will come back and repeat the baseline visit and the two main&#xD;
        testing days. The only difference is that participants will receive the other treatment that&#xD;
        was not received the first time (creatine monohydrate or placebo). Which treatment the&#xD;
        participant receives first or second will be at random.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">April 2025</completion_date>
    <primary_completion_date type="Anticipated">April 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Reactive oxygen species (ROS)</measure>
      <time_frame>Change from pre to post five days of creatine monohydrate supplementation at 0, 1, 2, 3, 4 hours post high carbohydrate meal</time_frame>
      <description>Reactive oxygen species as indicated by H2O2 concentration measured with microdialysis.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Muscle blood flow</measure>
      <time_frame>Change from pre to post five days of creatine monohydrate supplementation at 0, 1, 2, 3, 4 hours post high carbohydrate meal</time_frame>
      <description>Muscle microvascular blood flow as monitored with microdialysis</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Endothelial function</measure>
      <time_frame>Change from pre to post five days of creatine monohydrate supplementation at 0, 1, 2, 3, 4 hours post high carbohydrate meal</time_frame>
      <description>Endothelial function as measured with brachial artery flow mediated dilation</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Endothelial Dysfunction</condition>
    <arm_group>
      <arm_group_label>Creatine Monohydrate Supplementation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will be provided with 20 grams of creatine monohydrate per day (100 grams total) in sealed and unopened packages (5 grams in each package). Participants will be asked to complete their supplementation protocol (20 grams/day) by mixing 5 grams of creatine monohydrate powder into water 4 times a day or 10 grams of creatine monohydrate powder into water twice a day. This supplementation will occur after a baseline visit in which participants consume a high-carb meal and have their vascular function studied before the meal and four hours post-prandial. Following the 5 days of supplementation participants will come back and consume a high-carb meal and have their vascular function studied before the meal and four hours post-prandial.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo (Maltodextrin)</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Participants will be provided with 20 grams of maltodextrin (placebo) per day (100 grams total) in sealed and unopened packages (5 grams in each package). Participants will be asked to complete their supplementation protocol (20 grams/day) by mixing 5 grams of maltodextrin (placebo) into water 4 times a day or 10 grams of maltodextrin (placebo) powder into water twice a day. This supplementation will occur after a baseline visit in which participants consume a high-carb meal and have their vascular function studied before the meal and four hours post-prandial. Following the 5 days of supplementation participants will come back and consume a high-carb meal and have their vascular function studied before the meal and four hours post-prandial.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Creatine Monohydrate</intervention_name>
      <description>The supplementation is the intervention.</description>
      <arm_group_label>Creatine Monohydrate Supplementation</arm_group_label>
      <other_name>AlzChem</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Maltrodextrin (Placebo)</intervention_name>
      <description>Placebo to Creatine Monohydrate</description>
      <arm_group_label>Placebo (Maltodextrin)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Body Mass Index: 25.0-34.9 kg/m2&#xD;
  &#xD;
            -  Sedentary; sedentary status will be defined as not performing purposeful exercise&#xD;
               training more than 20 minutes per day three a week.&#xD;
  &#xD;
            -  Currently residing in Tallahassee, Florida, or the surrounding area&#xD;
  &#xD;
            -  Not taking any medication(s) that interfere with metabolism.&#xD;
  &#xD;
            -  Not taking any antioxidant supplementation, at least four weeks before the study.&#xD;
  &#xD;
            -  Not supplementing with creatine monohydrate, at least four weeks before the study.&#xD;
  &#xD;
            -  Not smoking, vaping, or chewing tobacco and willing to refrain from smoking, vaping,&#xD;
               and chewing tobacco throughout the entire study.&#xD;
  &#xD;
            -  Are not pregnant or planning on becoming pregnant&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Metabolic or cardiovascular abnormalities, gastrointestinal disorders, and any&#xD;
               condition that interferes with metabolism or oxygen delivery/transport including:&#xD;
  &#xD;
                 -  Diagnosed cardiovascular diseases or previous myocardial infarction.&#xD;
  &#xD;
                 -  Uncontrolled hypertension (resting: above 140 mmHg systolic or 90 mmHg diastolic)&#xD;
  &#xD;
                 -  Diabetes (Type 1 or 2)&#xD;
  &#xD;
                 -  Uncontrolled thyroid conditions&#xD;
  &#xD;
            -  Cigarette smoking: current cigarette smoker or those who quit within the previous 6&#xD;
               months.&#xD;
  &#xD;
            -  Participants consuming supplements or medication known to impact metabolism.&#xD;
  &#xD;
            -  Participants already consuming creatine monohydrate&#xD;
  &#xD;
            -  Allergies or intolerance to foods included in the standardized and high carbohydrate&#xD;
               meal.&#xD;
  &#xD;
            -  Women that are pregnant or planning on becoming pregnant&#xD;
  &#xD;
            -  Weight gain or loss &gt; 10% of body weight during the past 6 months&#xD;
  &#xD;
            -  Participants consume a vegan or vegetarian diet.&#xD;
  &#xD;
            -  Non-English-speaking individuals, infants, children, teenagers, cognitively impaired&#xD;
               adults individuals, and adults who are unable to consent will be recruited for the&#xD;
               study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Paul Baker, MS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Florida State University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Paul Baker, MS</last_name>
      <phone>6065472521</phone>
      <email>pab18df@fsu.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Robert Hickner, PhD</last_name>
      <email>rhickner@fsu.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Florida State University</name>
        <address>
          <city>Tallahassee</city>
          <state>Florida</state>
          <zip>32306</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Paul Baker</last_name>
        <email>pab18df@fsu.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 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>Florida State University</investigator_affiliation>
      <investigator_full_name>Paul Baker</investigator_full_name>
      <investigator_title>Graduate Research Assistant</investigator_title>
    </responsible_party>
    <keyword>Blood Flow, Endothelial Function, Supplementation</keyword>
    <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/NCT06018480
  org study id: STUDY00003857
  nct id: NCT06018480
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This research study seeks to determine the effects of an enzyme in the human body called
        NADPH oxidase (NOX) on blood flow. In addition, the study will investigate the benefits of
        creatine monohydrate, a common sports performance supplement, on blood food and vessel
        function. Participants will undergo two study arms, one in which they consume a high
        carbohydrate meal pre- and post-creatine monohydrate supplementation and one in which they
        will consume a high carbohydrate meal pre- and post-placebo supplementation. Blood flow and
        endothelial function will be assessed before and for 4 hours following the consumption of a
        high-carbohydrate meal pre and post-supplementation (creatine monohydrate and placebo).
  A double-blind cross-over placebo-controlled study design will be used to determine the
        extent to which NOX and creatine monohydrate supplementation influences skeletal muscle
        microvascular blood flow and endothelial function following the administration of a high
        carbohydrate meal in sedentary individuals with overweight/obesity. Participants will be
        initially screened through a telephone screening over the phone or through an electronic copy
        (Qualtrics survey) and upon meeting the inclusion criteria, will be scheduled for a baseline
        visit. At the baseline visits participants will go through an informed consent, background
        and medical history questionnaire alongside a DXA scan and indirect calorimetry.
        Subsequently, participants will undergo two main testing days, one will occur before
        supplementation (creatine monohydrate or placebo) and the other following five days of
        supplementation (creatine monohydrate or placebo). At the main testing days participants will
        have their resting blood flow and endothelial function assessed before and for 4 hours
        following the consumption of a high carbohydrate meal. Following the two main testing days in
        the first study arm, participants will then undergo a 4-week wash-out in which they will
        resume their normal behavior and stop taking the supplement they were provided. After the
        washout period, participants will come back and repeat the baseline visit and the two main
        testing days. The only difference is that participants will receive the other treatment that
        was not received the first time (creatine monohydrate or placebo). Which treatment the
        participant receives first or second will be at random.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Reactive oxygen species (ROS)
  time frame: Change from pre to post five days of creatine monohydrate supplementation at 0, 1, 2, 3, 4 hours post high carbohydrate meal
  description: Reactive oxygen species as indicated by H2O2 concentration measured with microdialysis.
  measure: Muscle blood flow
  time frame: Change from pre to post five days of creatine monohydrate supplementation at 0, 1, 2, 3, 4 hours post high carbohydrate meal
  description: Muscle microvascular blood flow as monitored with microdialysis
  measure: Endothelial function
  time frame: Change from pre to post five days of creatine monohydrate supplementation at 0, 1, 2, 3, 4 hours post high carbohydrate meal
  description: Endothelial function as measured with brachial artery flow mediated dilation
  arm group label: Creatine Monohydrate Supplementation
  arm group type: Experimental
  description: Participants will be provided with 20 grams of creatine monohydrate per day (100 grams total) in sealed and unopened packages (5 grams in each package). Participants will be asked to complete their supplementation protocol (20 grams/day) by mixing 5 grams of creatine monohydrate powder into water 4 times a day or 10 grams of creatine monohydrate powder into water twice a day. This supplementation will occur after a baseline visit in which participants consume a high-carb meal and have their vascular function studied before the meal and four hours post-prandial. Following the 5 days of supplementation participants will come back and consume a high-carb meal and have their vascular function studied before the meal and four hours post-prandial.
  arm group label: Placebo (Maltodextrin)
  arm group type: Placebo Comparator
  description: Participants will be provided with 20 grams of maltodextrin (placebo) per day (100 grams total) in sealed and unopened packages (5 grams in each package). Participants will be asked to complete their supplementation protocol (20 grams/day) by mixing 5 grams of maltodextrin (placebo) into water 4 times a day or 10 grams of maltodextrin (placebo) powder into water twice a day. This supplementation will occur after a baseline visit in which participants consume a high-carb meal and have their vascular function studied before the meal and four hours post-prandial. Following the 5 days of supplementation participants will come back and consume a high-carb meal and have their vascular function studied before the meal and four hours post-prandial.
  intervention type: Other
  intervention name: Creatine Monohydrate
  description: The supplementation is the intervention.
  arm group label: Creatine Monohydrate Supplementation
  other name: AlzChem
  intervention type: Other
  intervention name: Maltrodextrin (Placebo)
  description: Placebo to Creatine Monohydrate
  arm group label: Placebo (Maltodextrin)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Paul Baker, MS
  role: Principal Investigator
  affiliation: Florida State University
  last name: Paul Baker, MS
  phone: 6065472521
  email: pab18df@fsu.edu
  last name: Robert Hickner, PhD
  email: rhickner@fsu.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Florida State University
  investigator full name: Paul Baker
  investigator title: Graduate Research Assistant
  sharing ipd: No