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/NCT05992688</url>
    </required_header>
    <id_info>
      <org_study_id>275844</org_study_id>
      <nct_id>NCT05992688</nct_id>
    </id_info>
    <brief_title>The Sweet Kids Study</brief_title>
    <official_title>The Sweet Kids Study (Stevia on Weight and Energy Effect Over Time)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Arkansas Children's Hospital Research Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Cargill</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Arkansas Children's Hospital Research Institute</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 is an 8 to14-week three-arm randomized controlled in children 8 to 12 years old.&#xD;
  &#xD;
        The main purpose of the study is to evaluate if stevia (as with other sweeteners and&#xD;
        consistent with prior research in children and adults) has benefits for weight control and&#xD;
        metabolic function relative to caloric sweeteners, and whether it provides benefits in this&#xD;
        regard similar to water.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The proposed study will be an 8 to14-week three-arm randomized controlled blinded trial in&#xD;
        children ages 8 to12 years from the Central, Arkansas region. Children with normal weight&#xD;
        (BMI percentile &lt;85th, n = 90) and excessive weight (BMI percentile ≥85th and &lt;140% of the&#xD;
        95th, n =120) will consume either:&#xD;
  &#xD;
          1. Sucrose-sweetened beverage&#xD;
  &#xD;
          2. Stevia-sweetened beverage&#xD;
  &#xD;
          3. Calorie free flavored water beverage Participants with excessive weight will complete a&#xD;
             14-week intervention to assess both primary and secondary hypotheses. In parallel,&#xD;
             normal weight participants will be enrolled with the objective of monitoring indicators&#xD;
             of safety for steviol consumption through assessment of changes in metabolic function&#xD;
             (glucoregulation and cardiometabolic) markers as well as assessment of shifts in gut&#xD;
             microbial communities and steviol metabolism over 8 weeks&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2025</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>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>BMI z-scores</measure>
      <time_frame>8 to 14 weeks</time_frame>
      <description>Change in BMI z-scores</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fat mass index z-scores</measure>
      <time_frame>8 to 14 weeks</time_frame>
      <description>Change in fat mass index z-scores measured using DXA</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cardiometabolic health status</measure>
      <time_frame>8 to 14 weeks</time_frame>
      <description>A comprehensive composite score will be used to assess cardiometabolic health status of children</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gut microbial communities</measure>
      <time_frame>8 to 14 weeks</time_frame>
      <description>Shift in gut microbial communities will be assessed using 16S analyses</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">210</enrollment>
    <condition>Weight Gain</condition>
    <condition>Adiposity</condition>
    <condition>Insulin Sensitivity</condition>
    <condition>Microbial Colonization</condition>
    <arm_group>
      <arm_group_label>Sucrose sweetened beverage</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Sucrose (i.e. sugar): 25 g sugar (100 Kcal per serving). Participants will be asked to consume the study product once a day for 8 to 14 weeks if they have normal weight or excessive weight, respectively.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Stevia sweetened beverage</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The stevia-sweetened beverage contains 30.1 mg of steviol equivalents. Participants will be asked to consume the study product once a day for 8 to 14 weeks if they have normal weight or excessive weight, respectively.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Calorie free flavored water beverage</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Flavored water. Participants will be asked to consume the study product once a day for 8 to 14 weeks if they have normal weight or excessive weight, respectively.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Sucrose sweetened beverage</intervention_name>
      <description>Children who habitually consume sugar (sucrose) - sweetened beverages who are randomized to this arm, will consume the study product for 8 to 12 weeks.</description>
      <arm_group_label>Sucrose sweetened beverage</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Stevia sweetened beverages</intervention_name>
      <description>Children who habitually consume sugar (sucrose) - sweetened beverages who are randomized to this arm, will consume the study product for 8 to 12 weeks.</description>
      <arm_group_label>Stevia sweetened beverage</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Calorie free flavored water beverage</intervention_name>
      <description>Children who habitually consume sugar (sucrose) - sweetened beverages who are randomized to this arm, will consume the study product for 8 to 12 weeks.</description>
      <arm_group_label>Calorie free flavored water beverage</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 8-12 years&#xD;
  &#xD;
            -  Normal weight: BMI percentile ≥5th to &lt;85th&#xD;
  &#xD;
            -  Excessive weight: BMI percentile ≥ 85th and &lt;140% of the 95th percentile or BMI ≥35 to&#xD;
               &lt;40 kg/m2&#xD;
  &#xD;
            -  Current consumption of sugar sweetened beverages (≥3 times /wk)&#xD;
  &#xD;
            -  Low consumption of non-nutritive sweeteners (≤ 3 time/wk)&#xD;
  &#xD;
            -  Willingness to consume experimental products&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Children with class 3 obesity (i.e., BMI ≥ 140% of the 95th percentile or BMI ≥ 40.0&#xD;
               kg/m2)&#xD;
  &#xD;
            -  Dislike of experimental beverage taste (assessed at initial screening)&#xD;
  &#xD;
            -  Severe persistent asthma (determined by daily use of inhaler(s) to keep asthma&#xD;
               symptoms under control).&#xD;
  &#xD;
            -  Exercise induced asthma.&#xD;
  &#xD;
            -  Autism spectrum disorder (e.g., Autistic disorder, Rett disorder, Asperger disorder,&#xD;
               childhood disintegrative disorder, pervasive developmental disorder not otherwise&#xD;
               specified (PDD-NOS).&#xD;
  &#xD;
            -  Attention deficit hyperactivity disorder (ADHD).&#xD;
  &#xD;
            -  Oppositional defiant disorder (ODD).&#xD;
  &#xD;
            -  Epilepsy.&#xD;
  &#xD;
            -  Chronic kidney disease.&#xD;
  &#xD;
            -  Hormonal disease (e.g., hypothyroidism and growth hormone deficiency).&#xD;
  &#xD;
            -  Autoimmune diseases (e.g., lupus, thyroiditis, juvenile idiopathic arthritis)&#xD;
  &#xD;
            -  Bleeding disorders (e.g., hemophilia)&#xD;
  &#xD;
            -  Chronic infections (e.g., HIV, hepatitis B, hepatitis C).&#xD;
  &#xD;
            -  Mental health disorders (e.g., depression and anxiety).&#xD;
  &#xD;
            -  Type 2 and type 1 diabetes mellitus.&#xD;
  &#xD;
            -  Other pre-existing medical conditions or medications as determined by the&#xD;
               investigators to affect the outcomes of interest.&#xD;
  &#xD;
            -  Parent/child refusal to have blood drawn.&#xD;
  &#xD;
            -  Fasting glucose ≥126 mg/dl at enrollment.&#xD;
  &#xD;
            -  Fasting A1C ≥6.5% at enrollment or follow up visits.&#xD;
  &#xD;
            -  Less than 2 months since completion of antibiotics&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>8 Years</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Eva C Diaz, M.D.</last_name>
      <phone>5013643056</phone>
      <email>ecdiazfuentes@uams.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mario Ferruzzi, Ph.D.</last_name>
      <phone>5013642781</phone>
      <email>MFerruzzi@uams.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Arkansas Children's Nutrition Center</name>
        <address>
          <city>Little Rock</city>
          <state>Arkansas</state>
          <zip>72202</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Cardiometabolic health</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Communicable Diseases</mesh_term>
      <mesh_term>Infections</mesh_term>
      <mesh_term>Insulin Resistance</mesh_term>
      <mesh_term>Weight Gain</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>All study subject materials will be assigned a unique identifying code or number. The key to the code will be kept in a shared network folder with access granted only to study staff who have had appropriate CITI training. Only study investigators/staff will have access to the code and information that identifies the subject in this study. Coded data for all primary and secondary outcomes as well as secondary data analysis will be shared with the Sponsor (Cargill Corporation) using an approved shared folder .</ipd_description>
    </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/NCT05992688
  org study id: 275844
  nct id: NCT05992688
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is an 8 to14-week three-arm randomized controlled in children 8 to 12 years old.
  
        The main purpose of the study is to evaluate if stevia (as with other sweeteners and
        consistent with prior research in children and adults) has benefits for weight control and
        metabolic function relative to caloric sweeteners, and whether it provides benefits in this
        regard similar to water.
  The proposed study will be an 8 to14-week three-arm randomized controlled blinded trial in
        children ages 8 to12 years from the Central, Arkansas region. Children with normal weight
        (BMI percentile <85th, n = 90) and excessive weight (BMI percentile ≥85th and <140% of the
        95th, n =120) will consume either:
  
          1. Sucrose-sweetened beverage
  
          2. Stevia-sweetened beverage
  
          3. Calorie free flavored water beverage Participants with excessive weight will complete a
             14-week intervention to assess both primary and secondary hypotheses. In parallel,
             normal weight participants will be enrolled with the objective of monitoring indicators
             of safety for steviol consumption through assessment of changes in metabolic function
             (glucoregulation and cardiometabolic) markers as well as assessment of shifts in gut
             microbial communities and steviol metabolism over 8 weeks
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: BMI z-scores
  time frame: 8 to 14 weeks
  description: Change in BMI z-scores
  measure: Fat mass index z-scores
  time frame: 8 to 14 weeks
  description: Change in fat mass index z-scores measured using DXA
  measure: Cardiometabolic health status
  time frame: 8 to 14 weeks
  description: A comprehensive composite score will be used to assess cardiometabolic health status of children
  measure: Gut microbial communities
  time frame: 8 to 14 weeks
  description: Shift in gut microbial communities will be assessed using 16S analyses
  arm group label: Sucrose sweetened beverage
  arm group type: Active Comparator
  description: Sucrose (i.e. sugar): 25 g sugar (100 Kcal per serving). Participants will be asked to consume the study product once a day for 8 to 14 weeks if they have normal weight or excessive weight, respectively.
  arm group label: Stevia sweetened beverage
  arm group type: Experimental
  description: The stevia-sweetened beverage contains 30.1 mg of steviol equivalents. Participants will be asked to consume the study product once a day for 8 to 14 weeks if they have normal weight or excessive weight, respectively.
  arm group label: Calorie free flavored water beverage
  arm group type: Active Comparator
  description: Flavored water. Participants will be asked to consume the study product once a day for 8 to 14 weeks if they have normal weight or excessive weight, respectively.
  intervention type: Other
  intervention name: Sucrose sweetened beverage
  description: Children who habitually consume sugar (sucrose) - sweetened beverages who are randomized to this arm, will consume the study product for 8 to 12 weeks.
  arm group label: Sucrose sweetened beverage
  intervention type: Other
  intervention name: Stevia sweetened beverages
  description: Children who habitually consume sugar (sucrose) - sweetened beverages who are randomized to this arm, will consume the study product for 8 to 12 weeks.
  arm group label: Stevia sweetened beverage
  intervention type: Other
  intervention name: Calorie free flavored water beverage
  description: Children who habitually consume sugar (sucrose) - sweetened beverages who are randomized to this arm, will consume the study product for 8 to 12 weeks.
  arm group label: Calorie free flavored water beverage
  criteria: 
  gender: All
  minimum age: 8 Years
  maximum age: 12 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Eva C Diaz, M.D.
  phone: 5013643056
  email: ecdiazfuentes@uams.edu
  last name: Mario Ferruzzi, Ph.D.
  phone: 5013642781
  email: MFerruzzi@uams.edu
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Communicable Diseases
  mesh term: Infections
  mesh term: Insulin Resistance
  mesh term: Weight Gain
  sharing ipd: No
  ipd description: All study subject materials will be assigned a unique identifying code or number. The key to the code will be kept in a shared network folder with access granted only to study staff who have had appropriate CITI training. Only study investigators/staff will have access to the code and information that identifies the subject in this study. Coded data for all primary and secondary outcomes as well as secondary data analysis will be shared with the Sponsor (Cargill Corporation) using an approved shared folder .