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/NCT06041087</url>
    </required_header>
    <id_info>
      <org_study_id>2019-045b</org_study_id>
      <nct_id>NCT06041087</nct_id>
    </id_info>
    <brief_title>Bone and Inflammatory Outcomes - Nutrition and Exercise Trials</brief_title>
    <acronym>BIONEX</acronym>
    <official_title>Dairy Supplementation and the Post-Exercise Bone and Inflammatory Response</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>York University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>York University</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>
        This study investigates whether dairy products will positively impact loading&#xD;
        exercise-induced bone turnover and bone cell activity and/or the post-exercise inflammatory&#xD;
        response in healthy young adults compared to a carbohydrate drink and/or water.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Introduction: Two million individuals at a cost of around 4.6 billion dollars a year in&#xD;
        Canada suffer from osteoporosis. It is important to investigate strategies that can reduce&#xD;
        bone loss and/or increase bone mass. Similarly, inflammation is associated with many&#xD;
        different disease states, and investigating strategies to reduce systemic inflammation is&#xD;
        prudent. Nutrition and exercise may be inexpensive and accessible strategies to improve bone&#xD;
        health and inflammation and should be explored in different contexts and implemented. Our&#xD;
        proposed research combines both nutrition and exercise along with the assessment of bone&#xD;
        turnover and inflammatory markers in healthy young adults.&#xD;
  &#xD;
        Design: Randomized controlled crossover trial&#xD;
  &#xD;
        Participants: Healthy, university aged males and females.&#xD;
  &#xD;
        Methods: During the study participants will complete 4 different acute exercise and&#xD;
        nutritional supplement trials, in random order. The four trials are: 1) exercise+carbohydrate&#xD;
        (CHO), 2) exercise+milk (Milk), 3) exercise+Greek yogurt (GY), and 4) exercise+water (W). The&#xD;
        whole study will take a maximum of 16 weeks and each supplement trial will be separated by&#xD;
        2-4 weeks.&#xD;
  &#xD;
        Outcomes: several markers of bone turnover and bone cell activity as well as markers of&#xD;
        inflammation will be measured in the blood, before exercise and at different times&#xD;
        post-exercise and post supplement consumption.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 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>Basic Science</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Acute Bone Turnover/Cell Activity</measure>
      <time_frame>Pre-exercise</time_frame>
      <description>OPG measured in serum/plasma</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acute Bone Turnover/Cell Activity</measure>
      <time_frame>Pre-exercise</time_frame>
      <description>RANKL measured in serum/plasma</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acute Bone Turnover/Cell Activity</measure>
      <time_frame>Pre-exercise</time_frame>
      <description>OC measured in serum/plasma</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acute Bone Turnover/Cell Activity</measure>
      <time_frame>Pre-exercise</time_frame>
      <description>SOST measured in serum/plasma</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acute Bone Turnover/Cell Activity</measure>
      <time_frame>Pre-exercise</time_frame>
      <description>CTX measured in serum/plasma</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acute Bone Turnover/Cell Activity</measure>
      <time_frame>5 minutes post-exercise</time_frame>
      <description>OPG measured in serum/plasma</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acute Bone Turnover/Cell Activity</measure>
      <time_frame>5 minutes post-exercise</time_frame>
      <description>RANKL measured in serum/plasma</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acute Bone Turnover/Cell Activity</measure>
      <time_frame>5 minutes post-exercise</time_frame>
      <description>OC measured in serum/plasma</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acute Bone Turnover/Cell Activity</measure>
      <time_frame>5 minutes post-exercise</time_frame>
      <description>SOST measured in serum/plasma</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acute Bone Turnover/Cell Activity</measure>
      <time_frame>5 minutes post-exercise</time_frame>
      <description>CTX measured in serum/plasma</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acute Bone Turnover/Cell Activity</measure>
      <time_frame>1 hour post-exercise</time_frame>
      <description>OPG measured in serum/plasma</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acute Bone Turnover/Cell Activity</measure>
      <time_frame>1 hour post-exercise</time_frame>
      <description>RANKL measured in serum/plasma</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acute Bone Turnover/Cell Activity</measure>
      <time_frame>1 hour post-exercise</time_frame>
      <description>OC measured in serum/plasma</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acute Bone Turnover/Cell Activity</measure>
      <time_frame>1 hour post-exercise</time_frame>
      <description>SOST measured in serum/plasma</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acute Bone Turnover/Cell Activity</measure>
      <time_frame>1 hour post-exercise</time_frame>
      <description>CTX measured in serum/plasma</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acute Bone Turnover/Cell Activity</measure>
      <time_frame>4 hours post-exercise</time_frame>
      <description>OPG measured in serum/plasma</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acute Bone Turnover/Cell Activity</measure>
      <time_frame>4 hours post-exercise</time_frame>
      <description>RANKL measured in serum/plasma</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acute Bone Turnover/Cell Activity</measure>
      <time_frame>4 hours post-exercise</time_frame>
      <description>OC measured in serum/plasma</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acute Bone Turnover/Cell Activity</measure>
      <time_frame>4 hours post-exercise</time_frame>
      <description>SOST measured in serum/plasma</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acute Bone Turnover/Cell Activity</measure>
      <time_frame>4 hours post-exercise</time_frame>
      <description>CTX measured in serum/plasma</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acute Bone Turnover/Cell Activity</measure>
      <time_frame>24 hours post-exercise</time_frame>
      <description>OPG measured in serum/plasma</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acute Bone Turnover/Cell Activity</measure>
      <time_frame>24 hours post-exercise</time_frame>
      <description>RANKL measured in serum/plasma</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acute Bone Turnover/Cell Activity</measure>
      <time_frame>24 hours post-exercise</time_frame>
      <description>OC measured in serum/plasma</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acute Bone Turnover/Cell Activity</measure>
      <time_frame>24 hours post-exercise</time_frame>
      <description>SOST measured in serum/plasma</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acute Bone Turnover/Cell Activity</measure>
      <time_frame>24 hours post-exercise</time_frame>
      <description>CTX measured in serum/plasma</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Systemic Inflammation - Serum/Plasma Cytokines</measure>
      <time_frame>Pre-exercise</time_frame>
      <description>TNF-alpha measured in serum/plasma.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Systemic Inflammation - Serum/Plasma Cytokines</measure>
      <time_frame>Pre-exercise</time_frame>
      <description>IL-6 measured in serum/plasma.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Systemic Inflammation - Serum/Plasma Cytokines</measure>
      <time_frame>Pre-exercise</time_frame>
      <description>IL-1B measured in serum/plasma.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Systemic Inflammation - Serum/Plasma Cytokines</measure>
      <time_frame>Pre-exercise</time_frame>
      <description>IL-10 measured in serum/plasma.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Systemic Inflammation - Serum/Plasma Cytokines</measure>
      <time_frame>5 minutes post-exercise</time_frame>
      <description>TNF-alpha measured in serum/plasma.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Systemic Inflammation - Serum/Plasma Cytokines</measure>
      <time_frame>5 minutes post-exercise</time_frame>
      <description>IL-6 measured in serum/plasma.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Systemic Inflammation - Serum/Plasma Cytokines</measure>
      <time_frame>5 minutes post-exercise</time_frame>
      <description>IL-1B measured in serum/plasma.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Systemic Inflammation - Serum/Plasma Cytokines</measure>
      <time_frame>5 minutes post-exercise</time_frame>
      <description>IL-10 measured in serum/plasma.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Systemic Inflammation - Serum/Plasma Cytokines</measure>
      <time_frame>1 hour post-exercise</time_frame>
      <description>TNF-alpha measured in serum/plasma.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Systemic Inflammation - Serum/Plasma Cytokines</measure>
      <time_frame>1 hour post-exercise</time_frame>
      <description>IL-6 measured in serum/plasma.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Systemic Inflammation - Serum/Plasma Cytokines</measure>
      <time_frame>1 hour post-exercise</time_frame>
      <description>IL-1B measured in serum/plasma.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Systemic Inflammation - Serum/Plasma Cytokines</measure>
      <time_frame>1 hour post-exercise</time_frame>
      <description>IL-10 measured in serum/plasma.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Systemic Inflammation - Serum/Plasma Cytokines</measure>
      <time_frame>4 hours post-exercise</time_frame>
      <description>TNF-alpha measured in serum/plasma.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Systemic Inflammation - Serum/Plasma Cytokines</measure>
      <time_frame>4 hours post-exercise</time_frame>
      <description>IL-6 measured in serum/plasma.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Systemic Inflammation - Serum/Plasma Cytokines</measure>
      <time_frame>4 hours post-exercise</time_frame>
      <description>IL-1B measured in serum/plasma.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Systemic Inflammation - Serum/Plasma Cytokines</measure>
      <time_frame>4 hours post-exercise</time_frame>
      <description>IL-10 measured in serum/plasma.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Systemic Inflammation - Serum/Plasma Cytokines</measure>
      <time_frame>24 hours post-exercise</time_frame>
      <description>TNF-alpha measured in serum/plasma.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Systemic Inflammation - Serum/Plasma Cytokines</measure>
      <time_frame>24 hours post-exercise</time_frame>
      <description>IL-6 measured in serum/plasma.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Systemic Inflammation - Serum/Plasma Cytokines</measure>
      <time_frame>24 hours post-exercise</time_frame>
      <description>IL-1B measured in serum/plasma.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Systemic Inflammation - Serum/Plasma Cytokines</measure>
      <time_frame>24 hours post-exercise</time_frame>
      <description>IL-10 measured in serum/plasma.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Systemic inflammation - Immune Cells</measure>
      <time_frame>Pre-exercise</time_frame>
      <description>Leukocytes measured via flow cytometry</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Systemic inflammation - Immune Cells</measure>
      <time_frame>1 hour post-exercise</time_frame>
      <description>Leukocytes measured via flow cytometry</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Systemic inflammation - Immune Cells</measure>
      <time_frame>4 hours post-exercise</time_frame>
      <description>Leukocytes measured via flow cytometry</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Systemic inflammation - Immune Cells</measure>
      <time_frame>24 hours post-exercise</time_frame>
      <description>Leukocytes measured via flow cytometry</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Muscle soreness</measure>
      <time_frame>Pre-exercise</time_frame>
      <description>Muscle soreness rated on a 0-5 scale.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Muscle soreness</measure>
      <time_frame>5 minutes post-exercise</time_frame>
      <description>Muscle soreness rated on a 0-5 scale.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Muscle soreness</measure>
      <time_frame>4 hours post-exercise</time_frame>
      <description>Muscle soreness rated on a 0-5 scale.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Muscle soreness</measure>
      <time_frame>24 hours post-exercise</time_frame>
      <description>Muscle soreness rated on a 0-5 scale.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Performance - Jump Height</measure>
      <time_frame>Pre-exercise</time_frame>
      <description>Vertical jump height measured using a counter movement jump technique.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Performance - Jump Height</measure>
      <time_frame>5 minutes post-exercise</time_frame>
      <description>Vertical jump height measured using a counter movement jump technique.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Performance - Jump Height</measure>
      <time_frame>4 hours post-exercise</time_frame>
      <description>Vertical jump height measured using a counter movement jump technique.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Performance - Jump Height</measure>
      <time_frame>24 hours post-exercise</time_frame>
      <description>Vertical jump height measured using a counter movement jump technique.</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Healthy</condition>
    <condition>Bone</condition>
    <condition>Inflammation</condition>
    <arm_group>
      <arm_group_label>Exercise and Greek Yogurt (GY)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will have a fasted baseline blood sample taken upon arrival to the lab. Then they will take part in a high-intensity exercise protocol, consisting of high-intensity interval cycling, resistance exercise, and plyometrics. Following exercise, participants will return to the lab for a 5min post-exercise blood sample, and then consume ~200g Greek yogurt (0% milk fat). An additional blood sample will be taken at 1h post-exercise, followed by an additional ~200g of Greek yogurt. Blood samples will also be taken at 4h and 24h post-exercise. Participants will also rate their muscle soreness and perform a jump height test at pre-exercise, 5min post-exercise, 4h and 24h post-exercise.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Exercise and Milk (Milk)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will have a fasted baseline blood sample taken upon arrival to the lab. Then they will take part in a high-intensity exercise protocol, consisting of high-intensity interval cycling, resistance exercise, and plyometrics. Following exercise, participants will return to the lab for a 5min post-exercise blood sample, and then consume ~500ml plain skim milk (0% milk fat). An additional blood sample will be taken at 1h post-exercise, followed by an additional ~500ml of skim milk. Blood samples will also be taken at 4h and 24h post-exercise. Participants will also rate their muscle soreness and perform a jump height test at pre-exercise, 5min post-exercise, 4h and 24h post-exercise.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Exercise and Carbohydrate (CHO)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will have a fasted baseline blood sample taken upon arrival to the lab. Then they will take part in a high-intensity exercise protocol, consisting of high-intensity interval cycling, resistance exercise, and plyometrics. Following exercise, participants will return to the lab for a 5min post-exercise blood sample, and then consume ~50g of maltodextrin mixed with water (~500ml). An additional blood sample will be taken at 1h post-exercise, followed by an additional ~500ml of the maltodextrin drink. Blood samples will also be taken at 4h and 24h post-exercise. Participants will also rate their muscle soreness and perform a jump height test at pre-exercise, 5min post-exercise, 4h and 24h post-exercise.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Exercise and Water (W)</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Participants will have a fasted baseline blood sample taken upon arrival to the lab. Then they will take part in a high-intensity exercise protocol, consisting of high-intensity interval cycling, resistance exercise, and plyometrics. Following exercise, participants will return to the lab for a 5min post-exercise blood sample, and then consume ~500ml water. An additional blood sample will be taken at 1h post-exercise, followed by an additional ~500ml water. Blood samples will also be taken at 4h and 24h post-exercise. Participants will also rate their muscle soreness and perform a jump height test at pre-exercise, 5min post-exercise, 4h and 24h post-exercise.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>High-Intensity Exercise</intervention_name>
      <description>A single bout of high-intensity exercise (cycling intervals, resistance exercise, plyometrics) per trial.</description>
      <arm_group_label>Exercise and Carbohydrate (CHO)</arm_group_label>
      <arm_group_label>Exercise and Greek Yogurt (GY)</arm_group_label>
      <arm_group_label>Exercise and Milk (Milk)</arm_group_label>
      <arm_group_label>Exercise and Water (W)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Carbohydrate (Maltodextrin powder mixed with water)</intervention_name>
      <description>50g consumed immediately after exercise and 1h after exercise.</description>
      <arm_group_label>Exercise and Carbohydrate (CHO)</arm_group_label>
      <other_name>CHO</other_name>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Skim Milk</intervention_name>
      <description>500ml consumed immediately after exercise and 1h after exercise.</description>
      <arm_group_label>Exercise and Milk (Milk)</arm_group_label>
      <other_name>Milk</other_name>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Greek yogurt</intervention_name>
      <description>200g consumed immediately after exercise and 1h after exercise.</description>
      <arm_group_label>Exercise and Greek Yogurt (GY)</arm_group_label>
      <other_name>GY</other_name>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Water</intervention_name>
      <description>500ml consumed immediately after exercise and 1h after exercise.</description>
      <arm_group_label>Exercise and Water (W)</arm_group_label>
      <other_name>W</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Between the ages of 18-30 years&#xD;
  &#xD;
            -  Normal BMI (18.5-24.9) kg/m^2&#xD;
  &#xD;
            -  Low to moderately physically active (0-2 times/week)&#xD;
  &#xD;
            -  No allergy to dairy protein or lactose intolerance&#xD;
  &#xD;
            -  On no medication related to a chronic condition&#xD;
  &#xD;
            -  On birth control or naturally cycling with a regular menstrual cycle)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Regular smoker (cigarettes, e-cigarettes (e.g., vapes) or cannabis)&#xD;
  &#xD;
            -  Any chronic condition, inflammatory, or auto-immune condition&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>30 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Andrea R Josse, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>York University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Andrea R Josse, PhD</last_name>
      <phone>1-416-736-2100</phone>
      <phone_ext>30038</phone_ext>
      <email>ajosse@yorku.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Emily C Fraschetti, MSc</last_name>
      <email>ecfrasch@yorku.ca</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>York University</name>
        <address>
          <city>Toronto</city>
          <state>Ontario</state>
          <zip>M3J1P3</zip>
          <country>Canada</country>
        </address>
      </facility>
      <contact>
        <last_name>Andrea R Josse, PhD</last_name>
        <phone>1-(416)-736-2100</phone>
        <phone_ext>30038</phone_ext>
        <email>ajosse@yorku.ca</email>
      </contact>
      <contact_backup>
        <last_name>Emily C Fraschetti, MSc</last_name>
        <phone>1-(416) 736-2100</phone>
        <phone_ext>33990</phone_ext>
        <email>ecfrasch@yorku.ca</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>York University</investigator_affiliation>
      <investigator_full_name>Andrea Josse</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>Bone health</keyword>
    <keyword>Females</keyword>
    <keyword>Dairy</keyword>
    <keyword>Exercise</keyword>
    <keyword>Inflammation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Inflammation</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/NCT06041087
  org study id: 2019-045b
  nct id: NCT06041087
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study investigates whether dairy products will positively impact loading
        exercise-induced bone turnover and bone cell activity and/or the post-exercise inflammatory
        response in healthy young adults compared to a carbohydrate drink and/or water.
  Introduction: Two million individuals at a cost of around 4.6 billion dollars a year in
        Canada suffer from osteoporosis. It is important to investigate strategies that can reduce
        bone loss and/or increase bone mass. Similarly, inflammation is associated with many
        different disease states, and investigating strategies to reduce systemic inflammation is
        prudent. Nutrition and exercise may be inexpensive and accessible strategies to improve bone
        health and inflammation and should be explored in different contexts and implemented. Our
        proposed research combines both nutrition and exercise along with the assessment of bone
        turnover and inflammatory markers in healthy young adults.
  
        Design: Randomized controlled crossover trial
  
        Participants: Healthy, university aged males and females.
  
        Methods: During the study participants will complete 4 different acute exercise and
        nutritional supplement trials, in random order. The four trials are: 1) exercise+carbohydrate
        (CHO), 2) exercise+milk (Milk), 3) exercise+Greek yogurt (GY), and 4) exercise+water (W). The
        whole study will take a maximum of 16 weeks and each supplement trial will be separated by
        2-4 weeks.
  
        Outcomes: several markers of bone turnover and bone cell activity as well as markers of
        inflammation will be measured in the blood, before exercise and at different times
        post-exercise and post supplement consumption.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Basic Science
  masking: Single (Outcomes Assessor)
  measure: Acute Bone Turnover/Cell Activity
  time frame: Pre-exercise
  description: OPG measured in serum/plasma
  measure: Acute Bone Turnover/Cell Activity
  time frame: Pre-exercise
  description: RANKL measured in serum/plasma
  measure: Acute Bone Turnover/Cell Activity
  time frame: Pre-exercise
  description: OC measured in serum/plasma
  measure: Acute Bone Turnover/Cell Activity
  time frame: Pre-exercise
  description: SOST measured in serum/plasma
  measure: Acute Bone Turnover/Cell Activity
  time frame: Pre-exercise
  description: CTX measured in serum/plasma
  measure: Acute Bone Turnover/Cell Activity
  time frame: 5 minutes post-exercise
  description: OPG measured in serum/plasma
  measure: Acute Bone Turnover/Cell Activity
  time frame: 5 minutes post-exercise
  description: RANKL measured in serum/plasma
  measure: Acute Bone Turnover/Cell Activity
  time frame: 5 minutes post-exercise
  description: OC measured in serum/plasma
  measure: Acute Bone Turnover/Cell Activity
  time frame: 5 minutes post-exercise
  description: SOST measured in serum/plasma
  measure: Acute Bone Turnover/Cell Activity
  time frame: 5 minutes post-exercise
  description: CTX measured in serum/plasma
  measure: Acute Bone Turnover/Cell Activity
  time frame: 1 hour post-exercise
  description: OPG measured in serum/plasma
  measure: Acute Bone Turnover/Cell Activity
  time frame: 1 hour post-exercise
  description: RANKL measured in serum/plasma
  measure: Acute Bone Turnover/Cell Activity
  time frame: 1 hour post-exercise
  description: OC measured in serum/plasma
  measure: Acute Bone Turnover/Cell Activity
  time frame: 1 hour post-exercise
  description: SOST measured in serum/plasma
  measure: Acute Bone Turnover/Cell Activity
  time frame: 1 hour post-exercise
  description: CTX measured in serum/plasma
  measure: Acute Bone Turnover/Cell Activity
  time frame: 4 hours post-exercise
  description: OPG measured in serum/plasma
  measure: Acute Bone Turnover/Cell Activity
  time frame: 4 hours post-exercise
  description: RANKL measured in serum/plasma
  measure: Acute Bone Turnover/Cell Activity
  time frame: 4 hours post-exercise
  description: OC measured in serum/plasma
  measure: Acute Bone Turnover/Cell Activity
  time frame: 4 hours post-exercise
  description: SOST measured in serum/plasma
  measure: Acute Bone Turnover/Cell Activity
  time frame: 4 hours post-exercise
  description: CTX measured in serum/plasma
  measure: Acute Bone Turnover/Cell Activity
  time frame: 24 hours post-exercise
  description: OPG measured in serum/plasma
  measure: Acute Bone Turnover/Cell Activity
  time frame: 24 hours post-exercise
  description: RANKL measured in serum/plasma
  measure: Acute Bone Turnover/Cell Activity
  time frame: 24 hours post-exercise
  description: OC measured in serum/plasma
  measure: Acute Bone Turnover/Cell Activity
  time frame: 24 hours post-exercise
  description: SOST measured in serum/plasma
  measure: Acute Bone Turnover/Cell Activity
  time frame: 24 hours post-exercise
  description: CTX measured in serum/plasma
  measure: Systemic Inflammation - Serum/Plasma Cytokines
  time frame: Pre-exercise
  description: TNF-alpha measured in serum/plasma.
  measure: Systemic Inflammation - Serum/Plasma Cytokines
  time frame: Pre-exercise
  description: IL-6 measured in serum/plasma.
  measure: Systemic Inflammation - Serum/Plasma Cytokines
  time frame: Pre-exercise
  description: IL-1B measured in serum/plasma.
  measure: Systemic Inflammation - Serum/Plasma Cytokines
  time frame: Pre-exercise
  description: IL-10 measured in serum/plasma.
  measure: Systemic Inflammation - Serum/Plasma Cytokines
  time frame: 5 minutes post-exercise
  description: TNF-alpha measured in serum/plasma.
  measure: Systemic Inflammation - Serum/Plasma Cytokines
  time frame: 5 minutes post-exercise
  description: IL-6 measured in serum/plasma.
  measure: Systemic Inflammation - Serum/Plasma Cytokines
  time frame: 5 minutes post-exercise
  description: IL-1B measured in serum/plasma.
  measure: Systemic Inflammation - Serum/Plasma Cytokines
  time frame: 5 minutes post-exercise
  description: IL-10 measured in serum/plasma.
  measure: Systemic Inflammation - Serum/Plasma Cytokines
  time frame: 1 hour post-exercise
  description: TNF-alpha measured in serum/plasma.
  measure: Systemic Inflammation - Serum/Plasma Cytokines
  time frame: 1 hour post-exercise
  description: IL-6 measured in serum/plasma.
  measure: Systemic Inflammation - Serum/Plasma Cytokines
  time frame: 1 hour post-exercise
  description: IL-1B measured in serum/plasma.
  measure: Systemic Inflammation - Serum/Plasma Cytokines
  time frame: 1 hour post-exercise
  description: IL-10 measured in serum/plasma.
  measure: Systemic Inflammation - Serum/Plasma Cytokines
  time frame: 4 hours post-exercise
  description: TNF-alpha measured in serum/plasma.
  measure: Systemic Inflammation - Serum/Plasma Cytokines
  time frame: 4 hours post-exercise
  description: IL-6 measured in serum/plasma.
  measure: Systemic Inflammation - Serum/Plasma Cytokines
  time frame: 4 hours post-exercise
  description: IL-1B measured in serum/plasma.
  measure: Systemic Inflammation - Serum/Plasma Cytokines
  time frame: 4 hours post-exercise
  description: IL-10 measured in serum/plasma.
  measure: Systemic Inflammation - Serum/Plasma Cytokines
  time frame: 24 hours post-exercise
  description: TNF-alpha measured in serum/plasma.
  measure: Systemic Inflammation - Serum/Plasma Cytokines
  time frame: 24 hours post-exercise
  description: IL-6 measured in serum/plasma.
  measure: Systemic Inflammation - Serum/Plasma Cytokines
  time frame: 24 hours post-exercise
  description: IL-1B measured in serum/plasma.
  measure: Systemic Inflammation - Serum/Plasma Cytokines
  time frame: 24 hours post-exercise
  description: IL-10 measured in serum/plasma.
  measure: Systemic inflammation - Immune Cells
  time frame: Pre-exercise
  description: Leukocytes measured via flow cytometry
  measure: Systemic inflammation - Immune Cells
  time frame: 1 hour post-exercise
  description: Leukocytes measured via flow cytometry
  measure: Systemic inflammation - Immune Cells
  time frame: 4 hours post-exercise
  description: Leukocytes measured via flow cytometry
  measure: Systemic inflammation - Immune Cells
  time frame: 24 hours post-exercise
  description: Leukocytes measured via flow cytometry
  measure: Muscle soreness
  time frame: Pre-exercise
  description: Muscle soreness rated on a 0-5 scale.
  measure: Muscle soreness
  time frame: 5 minutes post-exercise
  description: Muscle soreness rated on a 0-5 scale.
  measure: Muscle soreness
  time frame: 4 hours post-exercise
  description: Muscle soreness rated on a 0-5 scale.
  measure: Muscle soreness
  time frame: 24 hours post-exercise
  description: Muscle soreness rated on a 0-5 scale.
  measure: Performance - Jump Height
  time frame: Pre-exercise
  description: Vertical jump height measured using a counter movement jump technique.
  measure: Performance - Jump Height
  time frame: 5 minutes post-exercise
  description: Vertical jump height measured using a counter movement jump technique.
  measure: Performance - Jump Height
  time frame: 4 hours post-exercise
  description: Vertical jump height measured using a counter movement jump technique.
  measure: Performance - Jump Height
  time frame: 24 hours post-exercise
  description: Vertical jump height measured using a counter movement jump technique.
  arm group label: Exercise and Greek Yogurt (GY)
  arm group type: Experimental
  description: Participants will have a fasted baseline blood sample taken upon arrival to the lab. Then they will take part in a high-intensity exercise protocol, consisting of high-intensity interval cycling, resistance exercise, and plyometrics. Following exercise, participants will return to the lab for a 5min post-exercise blood sample, and then consume ~200g Greek yogurt (0% milk fat). An additional blood sample will be taken at 1h post-exercise, followed by an additional ~200g of Greek yogurt. Blood samples will also be taken at 4h and 24h post-exercise. Participants will also rate their muscle soreness and perform a jump height test at pre-exercise, 5min post-exercise, 4h and 24h post-exercise.
  arm group label: Exercise and Milk (Milk)
  arm group type: Experimental
  description: Participants will have a fasted baseline blood sample taken upon arrival to the lab. Then they will take part in a high-intensity exercise protocol, consisting of high-intensity interval cycling, resistance exercise, and plyometrics. Following exercise, participants will return to the lab for a 5min post-exercise blood sample, and then consume ~500ml plain skim milk (0% milk fat). An additional blood sample will be taken at 1h post-exercise, followed by an additional ~500ml of skim milk. Blood samples will also be taken at 4h and 24h post-exercise. Participants will also rate their muscle soreness and perform a jump height test at pre-exercise, 5min post-exercise, 4h and 24h post-exercise.
  arm group label: Exercise and Carbohydrate (CHO)
  arm group type: Active Comparator
  description: Participants will have a fasted baseline blood sample taken upon arrival to the lab. Then they will take part in a high-intensity exercise protocol, consisting of high-intensity interval cycling, resistance exercise, and plyometrics. Following exercise, participants will return to the lab for a 5min post-exercise blood sample, and then consume ~50g of maltodextrin mixed with water (~500ml). An additional blood sample will be taken at 1h post-exercise, followed by an additional ~500ml of the maltodextrin drink. Blood samples will also be taken at 4h and 24h post-exercise. Participants will also rate their muscle soreness and perform a jump height test at pre-exercise, 5min post-exercise, 4h and 24h post-exercise.
  arm group label: Exercise and Water (W)
  arm group type: Placebo Comparator
  description: Participants will have a fasted baseline blood sample taken upon arrival to the lab. Then they will take part in a high-intensity exercise protocol, consisting of high-intensity interval cycling, resistance exercise, and plyometrics. Following exercise, participants will return to the lab for a 5min post-exercise blood sample, and then consume ~500ml water. An additional blood sample will be taken at 1h post-exercise, followed by an additional ~500ml water. Blood samples will also be taken at 4h and 24h post-exercise. Participants will also rate their muscle soreness and perform a jump height test at pre-exercise, 5min post-exercise, 4h and 24h post-exercise.
  intervention type: Behavioral
  intervention name: High-Intensity Exercise
  description: A single bout of high-intensity exercise (cycling intervals, resistance exercise, plyometrics) per trial.
  arm group label: Exercise and Carbohydrate (CHO)
  arm group label: Exercise and Greek Yogurt (GY)
  arm group label: Exercise and Milk (Milk)
  arm group label: Exercise and Water (W)
  intervention type: Dietary Supplement
  intervention name: Carbohydrate (Maltodextrin powder mixed with water)
  description: 50g consumed immediately after exercise and 1h after exercise.
  arm group label: Exercise and Carbohydrate (CHO)
  other name: CHO
  intervention type: Dietary Supplement
  intervention name: Skim Milk
  description: 500ml consumed immediately after exercise and 1h after exercise.
  arm group label: Exercise and Milk (Milk)
  other name: Milk
  intervention type: Dietary Supplement
  intervention name: Greek yogurt
  description: 200g consumed immediately after exercise and 1h after exercise.
  arm group label: Exercise and Greek Yogurt (GY)
  other name: GY
  intervention type: Dietary Supplement
  intervention name: Water
  description: 500ml consumed immediately after exercise and 1h after exercise.
  arm group label: Exercise and Water (W)
  other name: W
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 30 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Andrea R Josse, PhD
  role: Principal Investigator
  affiliation: York University
  last name: Andrea R Josse, PhD
  phone: 1-416-736-2100
  phone ext: 30038
  email: ajosse@yorku.ca
  last name: Emily C Fraschetti, MSc
  email: ecfrasch@yorku.ca
  facility: 
  contact: 
  contact backup: 
  country: Canada
  responsible party type: Principal Investigator
  investigator affiliation: York University
  investigator full name: Andrea Josse
  investigator title: Assistant Professor
  mesh term: Inflammation
  sharing ipd: No