<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/NCT04419415</url>
  </required_header>
  <id_info>
    <org_study_id>ProteinLab_P9_NyStart</org_study_id>
    <nct_id>NCT04419415</nct_id>
  </id_info>
  <brief_title>Breakfast for Female Adolescent - NewStart</brief_title>
  <acronym>NewStart</acronym>
  <official_title>Breakfast for Female Adolescent - NewStart</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Danish Dairy Research Foundation, Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Investigators will test the long-term health effects of eating a dairy-based protein-rich&#xD;
      breakfast and/or performing regular physical training for 12 weeks in 100 previous 'breakfast&#xD;
      skipping' young overweight women (2 x 2 factorial design). Measurements of body composition,&#xD;
      physical fitness, metabolic health parameters, faeces (microbiota activity and composition),&#xD;
      satiety and daily energy intake will be collected.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a 2×2-factorial randomized controlled trial with 4 study arms. The subjects will&#xD;
      be randomly allocated to skip breakfast or eat high-protein yoghurt products (300g/day) and&#xD;
      to either exercise 3x per week or maintain habitual physical activity for 12 weeks.&#xD;
      Measurements and biological sampling will be performed at baseline and at the end of the&#xD;
      intervention period.&#xD;
&#xD;
      The primary outcome will be fat mass and fat free mass. The investigators will also measure&#xD;
      effects on weigth, waiste, health-related blood paramenters, muscle function, metabolites in&#xD;
      urine and blood, and gut microflora and pH.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    covid-19 lock down&#xD;
  </why_stopped>
  <start_date type="Actual">December 15, 2019</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">June 1, 2020</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>Factorial Assignment</intervention_model>
    <intervention_model_description>2x2 design</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Body composition (DXA scan) 1</measure>
    <time_frame>12 weeks</time_frame>
    <description>Fat mass in grams</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body composition (DXA scan) 2</measure>
    <time_frame>12 weeks</time_frame>
    <description>Fat free mass in grams</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HbA1c</measure>
    <time_frame>12 weeks</time_frame>
    <description>Blood sample measurement of HbA1c</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDL</measure>
    <time_frame>12 weeks</time_frame>
    <description>Blood sample measurement of LDL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HDL</measure>
    <time_frame>12 weeks</time_frame>
    <description>Blood sample measurement of HDL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related blood parameter 1</measure>
    <time_frame>12 weeks</time_frame>
    <description>blood sample measurement of fasting glucose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related blood parameter 2</measure>
    <time_frame>12 weeks</time_frame>
    <description>Blood sample measurement of fasting insulin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related parameter</measure>
    <time_frame>12 weeks</time_frame>
    <description>Oral glucose tolerance test measured as the area under the curve</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fitness</measure>
    <time_frame>12 weeks</time_frame>
    <description>Aastrand bike test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle strength</measure>
    <time_frame>12 weeks</time_frame>
    <description>grib strength (kg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>maximal jump height</measure>
    <time_frame>12 weeks</time_frame>
    <description>maximal jump height (cm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>weight</measure>
    <time_frame>12 weeks</time_frame>
    <description>Body weight (kg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>12 weeks</time_frame>
    <description>Body hight (m)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI</measure>
    <time_frame>12 weeks</time_frame>
    <description>weight measurement in kg, height in meters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Food log</measure>
    <time_frame>12 weeks</time_frame>
    <description>4-day food log (energy in KJ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gut microflora</measure>
    <time_frame>12 weeks</time_frame>
    <description>by bacterial determination of faeces</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feaces pH</measure>
    <time_frame>12 weeks</time_frame>
    <description>by pH determination of faeces</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urine metabolites</measure>
    <time_frame>12 weeks</time_frame>
    <description>by metabolomics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood metabolites</measure>
    <time_frame>12 weeks</time_frame>
    <description>by metabolomics</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Overweight Adolescents</condition>
  <condition>Metabolic Disease</condition>
  <arm_group>
    <arm_group_label>Skipping breakfast and maintain habitual physical activity</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subject will skip breakfast and maintain habitual physical activity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High protein breakfast and maintain habitual physical activity</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subject will consume a high protein dairy breakfast (300 g high protein yoghurt (skyr)) and maintain habitual physical activity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Skipping breakfast and exercising three times per week</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subject will skip breakfast and participate in organized exercise-training three times per week (and maintain habitual physical activity)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High protein breakfast and exercising three times per week</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subject will consume a high protein dairy breakfast (300 g high protein yoghurt (skyr)) and and participate in organized exercise-training three times per week (and maintain habitual physical activity)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Breakfast with high protein dairy</intervention_name>
    <description>High protein yoghurt containing approx. 10 g protein per 100 g. Participants will be asked to consume 300 g (=3 dl) for breakfast.</description>
    <arm_group_label>High protein breakfast and exercising three times per week</arm_group_label>
    <arm_group_label>High protein breakfast and maintain habitual physical activity</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise training</intervention_name>
    <description>Participants will be asked to participate in organized exercise training 3 times per week.</description>
    <arm_group_label>High protein breakfast and exercising three times per week</arm_group_label>
    <arm_group_label>Skipping breakfast and exercising three times per week</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Skipping breakfast</intervention_name>
    <description>Participants will be asked to skip breakfast.</description>
    <arm_group_label>High protein breakfast and maintain habitual physical activity</arm_group_label>
    <arm_group_label>Skipping breakfast and maintain habitual physical activity</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI &gt;25&#xD;
&#xD;
          -  exercising &lt; 1 h per week.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  smoking&#xD;
&#xD;
          -  illness and use of medication affecting the study outcomes&#xD;
&#xD;
          -  allergy towards milk and yoghurt&#xD;
&#xD;
          -  weightloss/gain &gt;5kg the last 6 months&#xD;
&#xD;
          -  dieting&#xD;
&#xD;
          -  eating disorder&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  breast feeding&#xD;
&#xD;
          -  unable to speak and understand danish&#xD;
      </textblock>
    </criteria>
    <gender>Female</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>Mette Hansen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Aarhus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aarhus University, Department for Public Health, Section for Sport Science</name>
      <address>
        <city>Aarhus</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>March 13, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>April 28, 2021</last_update_submitted>
  <last_update_submitted_qc>April 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Aarhus</investigator_affiliation>
    <investigator_full_name>Mette Hansen</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Metabolic Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04419415
org study id: ProteinLab_P9_NyStart
nct id: NCT04419415
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Investigators will test the long-term health effects of eating a dairy-based protein-rich
      breakfast and/or performing regular physical training for 12 weeks in 100 previous 'breakfast
      skipping' young overweight women (2 x 2 factorial design). Measurements of body composition,
      physical fitness, metabolic health parameters, faeces (microbiota activity and composition),
      satiety and daily energy intake will be collected.
The study is a 2×2-factorial randomized controlled trial with 4 study arms. The subjects will
      be randomly allocated to skip breakfast or eat high-protein yoghurt products (300g/day) and
      to either exercise 3x per week or maintain habitual physical activity for 12 weeks.
      Measurements and biological sampling will be performed at baseline and at the end of the
      intervention period.

      The primary outcome will be fat mass and fat free mass. The investigators will also measure
      effects on weigth, waiste, health-related blood paramenters, muscle function, metabolites in
      urine and blood, and gut microflora and pH.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: 2x2 design
primary purpose: Prevention
masking: None (Open Label)
measure: Body composition (DXA scan) 1
time frame: 12 weeks
description: Fat mass in grams
measure: Body composition (DXA scan) 2
time frame: 12 weeks
description: Fat free mass in grams
measure: HbA1c
time frame: 12 weeks
description: Blood sample measurement of HbA1c
measure: LDL
time frame: 12 weeks
description: Blood sample measurement of LDL
measure: HDL
time frame: 12 weeks
description: Blood sample measurement of HDL
measure: Health related blood parameter 1
time frame: 12 weeks
description: blood sample measurement of fasting glucose
measure: Health related blood parameter 2
time frame: 12 weeks
description: Blood sample measurement of fasting insulin
measure: Health related parameter
time frame: 12 weeks
description: Oral glucose tolerance test measured as the area under the curve
measure: Fitness
time frame: 12 weeks
description: Aastrand bike test
measure: Muscle strength
time frame: 12 weeks
description: grib strength (kg)
measure: maximal jump height
time frame: 12 weeks
description: maximal jump height (cm)
measure: weight
time frame: 12 weeks
description: Body weight (kg)
measure: Height
time frame: 12 weeks
description: Body hight (m)
measure: BMI
time frame: 12 weeks
description: weight measurement in kg, height in meters
measure: Food log
time frame: 12 weeks
description: 4-day food log (energy in KJ)
measure: Gut microflora
time frame: 12 weeks
description: by bacterial determination of faeces
measure: Feaces pH
time frame: 12 weeks
description: by pH determination of faeces
measure: Urine metabolites
time frame: 12 weeks
description: by metabolomics
measure: Blood metabolites
time frame: 12 weeks
description: by metabolomics
arm group label: Skipping breakfast and maintain habitual physical activity
arm group type: Experimental
description: Subject will skip breakfast and maintain habitual physical activity.
arm group label: High protein breakfast and maintain habitual physical activity
arm group type: Experimental
description: Subject will consume a high protein dairy breakfast (300 g high protein yoghurt (skyr)) and maintain habitual physical activity.
arm group label: Skipping breakfast and exercising three times per week
arm group type: Experimental
description: Subject will skip breakfast and participate in organized exercise-training three times per week (and maintain habitual physical activity)
arm group label: High protein breakfast and exercising three times per week
arm group type: Experimental
description: Subject will consume a high protein dairy breakfast (300 g high protein yoghurt (skyr)) and and participate in organized exercise-training three times per week (and maintain habitual physical activity)
intervention type: Dietary Supplement
intervention name: Breakfast with high protein dairy
description: High protein yoghurt containing approx. 10 g protein per 100 g. Participants will be asked to consume 300 g (=3 dl) for breakfast.
arm group label: High protein breakfast and exercising three times per week
arm group label: High protein breakfast and maintain habitual physical activity
intervention type: Other
intervention name: Exercise training
description: Participants will be asked to participate in organized exercise training 3 times per week.
arm group label: High protein breakfast and exercising three times per week
arm group label: Skipping breakfast and exercising three times per week
intervention type: Other
intervention name: Skipping breakfast
description: Participants will be asked to skip breakfast.
arm group label: High protein breakfast and maintain habitual physical activity
arm group label: Skipping breakfast and maintain habitual physical activity
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mette Hansen, PhD
role: Principal Investigator
affiliation: University of Aarhus
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University of Aarhus
investigator full name: Mette Hansen
investigator title: Associate professor
mesh term: Overweight
mesh term: Metabolic Diseases
sharing ipd: No