<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/NCT04430465</url>
  </required_header>
  <id_info>
    <org_study_id>D225</org_study_id>
    <nct_id>NCT04430465</nct_id>
  </id_info>
  <brief_title>Effects of Wholegrains on Children's Health (KORN)</brief_title>
  <official_title>Effects of Wholegrains on Children's Health (KORN)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chalmers University of Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Copenhagen</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>
      KORN investigates the effects of wholegrain oat and rye intake on health and cognitive&#xD;
      wellbeing in children with overweight.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of KORN is to investigate the effects of wholegrain oat and rye intake on&#xD;
      cardiometabolic health in slightly overweight 8-13-year-old children. Moreover, KORN aims to&#xD;
      investigate effects on body weight and body composition, inflammatory markers,&#xD;
      gastrointestinal wellbeing and cognitive function and explore the potential underlying&#xD;
      mechanisms through assessment of changes in the children's gut microbiota as well as&#xD;
      potential genotype-dependent and sex-specific effects.&#xD;
&#xD;
      The study has a randomized controlled cross-over design. In two 8-week dietary periods the&#xD;
      children will receive grain products (cereals, breads, pasta etc) with either high or low&#xD;
      content of wholegrain from oat and rye in random order. Measurements and biological sampling&#xD;
      will be performed at 0, 8 and 16 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 3, 2020</start_date>
  <completion_date type="Actual">May 4, 2021</completion_date>
  <primary_completion_date type="Actual">May 4, 2021</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The intervention and data collection will be conducted unmasked. The data set will be masked before data analysis by staff not involved in the study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Low density lipoprotein cholesterol</measure>
    <time_frame>16 weeks</time_frame>
    <description>by fasting blood sample</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Insulin</measure>
    <time_frame>16 weeks</time_frame>
    <description>by fasting blood sample</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>16 weeks</time_frame>
    <description>by stadiometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>16 weeks</time_frame>
    <description>by digital scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index z-score</measure>
    <time_frame>16 weeks</time_frame>
    <description>by height and weight measurements</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference</measure>
    <time_frame>16 weeks</time_frame>
    <description>by measuring tape</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat mass index</measure>
    <time_frame>16 weeks</time_frame>
    <description>by Dual-energy X-ray Absorptiometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat free mass index</measure>
    <time_frame>16 weeks</time_frame>
    <description>by Dual-energy X-ray Absorptiometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic blood pressure</measure>
    <time_frame>16 weeks</time_frame>
    <description>by digital device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic blood pressure</measure>
    <time_frame>16 weeks</time_frame>
    <description>by digital device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>16 weeks</time_frame>
    <description>by digital device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose</measure>
    <time_frame>16 weeks</time_frame>
    <description>by fasting blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycosylated hemoglobin (HbA1c)</measure>
    <time_frame>16 weeks</time_frame>
    <description>by fasting blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triacylglycerol</measure>
    <time_frame>16 weeks</time_frame>
    <description>by fasting blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>High density lipoprotein cholesterol</measure>
    <time_frame>16 weeks</time_frame>
    <description>by fasting blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total cholesterol</measure>
    <time_frame>16 weeks</time_frame>
    <description>by fasting blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>High sensitivity C-reactive protein</measure>
    <time_frame>16 weeks</time_frame>
    <description>by fasting blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attention</measure>
    <time_frame>16 weeks</time_frame>
    <description>assessed by d2 test of attention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inhibition</measure>
    <time_frame>16 weeks</time_frame>
    <description>assessed by Stroop color and word test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Processing speed</measure>
    <time_frame>16 weeks</time_frame>
    <description>assessed by d2 test of attention and Stroop color and word test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Working memory</measure>
    <time_frame>16 weeks</time_frame>
    <description>assessed by Kim's game</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Socio-emotional skills</measure>
    <time_frame>16 weeks</time_frame>
    <description>assessed by parent reported Strengths and Difficulties Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stool consistency</measure>
    <time_frame>16 weeks</time_frame>
    <description>assessed by the Bristol stool scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal wellbeing</measure>
    <time_frame>16 weeks</time_frame>
    <description>assessed by questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of overweight</measure>
    <time_frame>16 weeks</time_frame>
    <description>By the International Obesity Task Force criteria</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Dietary intake</measure>
    <time_frame>16 weeks</time_frame>
    <description>assessed by 4-day dietary record</description>
  </other_outcome>
  <other_outcome>
    <measure>Physical activity</measure>
    <time_frame>16 weeks</time_frame>
    <description>assessed by questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Sociodemographic characteristics</measure>
    <time_frame>at baseline</time_frame>
    <description>assessed by questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Pubertal development stage</measure>
    <time_frame>at baseline</time_frame>
    <description>assessed by the Tanner scales</description>
  </other_outcome>
  <other_outcome>
    <measure>General satisfaction</measure>
    <time_frame>16 weeks</time_frame>
    <description>assessed by questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Liking of study products</measure>
    <time_frame>16 weeks</time_frame>
    <description>assessed by questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Alkylresorcinols (compliance)</measure>
    <time_frame>16 weeks</time_frame>
    <description>by fasting blood sample</description>
  </other_outcome>
  <other_outcome>
    <measure>Android fat mass index</measure>
    <time_frame>16 weeks</time_frame>
    <description>by Dual-energy X-ray Absorptiometry</description>
  </other_outcome>
  <other_outcome>
    <measure>Gynoid fat mass index</measure>
    <time_frame>16 weeks</time_frame>
    <description>by Dual-energy X-ray Absorptiometry</description>
  </other_outcome>
  <other_outcome>
    <measure>Android:gynoid fat mass ratio</measure>
    <time_frame>16 weeks</time_frame>
    <description>by Dual-energy X-ray Absorptiometry</description>
  </other_outcome>
  <other_outcome>
    <measure>Immune cell count</measure>
    <time_frame>16 weeks</time_frame>
    <description>by fasting blood sample</description>
  </other_outcome>
  <other_outcome>
    <measure>Interleukin 6 (IL-6)</measure>
    <time_frame>16 weeks</time_frame>
    <description>by fasting blood sample</description>
  </other_outcome>
  <other_outcome>
    <measure>Interleukin 1β (IL-1β)</measure>
    <time_frame>16 weeks</time_frame>
    <description>by fasting blood sample</description>
  </other_outcome>
  <other_outcome>
    <measure>Tumor necrosis factor alpha (TNFα)</measure>
    <time_frame>16 weeks</time_frame>
    <description>by fasting blood sample</description>
  </other_outcome>
  <other_outcome>
    <measure>Bone Mineral Density</measure>
    <time_frame>16 weeks</time_frame>
    <description>by Dual-energy X-ray Absorptiometry</description>
  </other_outcome>
  <other_outcome>
    <measure>Bone Mineral Content</measure>
    <time_frame>16 weeks</time_frame>
    <description>by Dual-energy X-ray Absorptiometry</description>
  </other_outcome>
  <other_outcome>
    <measure>Bone area</measure>
    <time_frame>16 weeks</time_frame>
    <description>by Dual-energy X-ray Absorptiometry</description>
  </other_outcome>
  <other_outcome>
    <measure>Gut microbiome composition determined by high throughput sequencing and qPCR</measure>
    <time_frame>16 weeks</time_frame>
    <description>by fecal sample</description>
  </other_outcome>
  <other_outcome>
    <measure>Short chain fatty acids</measure>
    <time_frame>16 weeks</time_frame>
    <description>by fasting blood sample</description>
  </other_outcome>
  <other_outcome>
    <measure>Short chain fatty acids</measure>
    <time_frame>16 weeks</time_frame>
    <description>by fecal sample</description>
  </other_outcome>
  <other_outcome>
    <measure>Bile acids</measure>
    <time_frame>16 weeks</time_frame>
    <description>by fasting blood sample</description>
  </other_outcome>
  <other_outcome>
    <measure>Bile acids</measure>
    <time_frame>16 weeks</time_frame>
    <description>by fecal sample</description>
  </other_outcome>
  <other_outcome>
    <measure>Fatty acid composition</measure>
    <time_frame>16 weeks</time_frame>
    <description>by fasting blood sample</description>
  </other_outcome>
  <other_outcome>
    <measure>C-peptide</measure>
    <time_frame>16 weeks</time_frame>
    <description>by fasting blood sample</description>
  </other_outcome>
  <other_outcome>
    <measure>Epigenetics</measure>
    <time_frame>16 weeks</time_frame>
    <description>by fasting blood sample</description>
  </other_outcome>
  <other_outcome>
    <measure>Metabolomics</measure>
    <time_frame>16 weeks</time_frame>
    <description>by fasting blood sample</description>
  </other_outcome>
  <other_outcome>
    <measure>Metabolomics</measure>
    <time_frame>16 weeks</time_frame>
    <description>by fecal sample</description>
  </other_outcome>
  <other_outcome>
    <measure>Proteomics</measure>
    <time_frame>16 weeks</time_frame>
    <description>by fasting blood sample</description>
  </other_outcome>
  <other_outcome>
    <measure>Proteomics</measure>
    <time_frame>16 weeks</time_frame>
    <description>by fecal sample</description>
  </other_outcome>
  <other_outcome>
    <measure>Genotypes</measure>
    <time_frame>16 weeks</time_frame>
    <description>by fasting blood sample</description>
  </other_outcome>
  <other_outcome>
    <measure>Adiponectin</measure>
    <time_frame>16 weeks</time_frame>
    <description>by fasting blood sample</description>
  </other_outcome>
  <other_outcome>
    <measure>Leptin</measure>
    <time_frame>16 weeks</time_frame>
    <description>by fasting blood sample</description>
  </other_outcome>
  <other_outcome>
    <measure>Appetite hormones</measure>
    <time_frame>16 weeks</time_frame>
    <description>by fasting blood sample</description>
  </other_outcome>
  <other_outcome>
    <measure>Testosterone</measure>
    <time_frame>16 weeks</time_frame>
    <description>by fasting blood sample</description>
  </other_outcome>
  <other_outcome>
    <measure>Estrogen</measure>
    <time_frame>16 weeks</time_frame>
    <description>by fasting blood sample</description>
  </other_outcome>
  <other_outcome>
    <measure>Gonadotropins</measure>
    <time_frame>16 weeks</time_frame>
    <description>by fasting blood sample</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Cardiometabolic Health</condition>
  <condition>Gastro-intestinal Wellbeing</condition>
  <condition>Cognitive Function</condition>
  <condition>Overweight</condition>
  <arm_group>
    <arm_group_label>High wholegrain then low wholegrain</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Starting with high wholegrain intervention followed by low wholegrain intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low wholegrain then high wholegrain</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Starting with low wholegrain intervention followed by high wholegrain intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Grain products high in wholegrains from oat and rye</intervention_name>
    <description>A selection of grainproducts high in wholegrain from oat and rye, including cereals, bread, rolls, and pasta is replacing habitual grain products</description>
    <arm_group_label>High wholegrain then low wholegrain</arm_group_label>
    <arm_group_label>Low wholegrain then high wholegrain</arm_group_label>
    <other_name>Wholegrain</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Grain products low in wholegrains</intervention_name>
    <description>A selection of grainproducts low in wholegrain, including cereals, bread, rolls, and pasta is replacing habitual grain products</description>
    <arm_group_label>High wholegrain then low wholegrain</arm_group_label>
    <arm_group_label>Low wholegrain then high wholegrain</arm_group_label>
    <other_name>Refined grain</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Boys and girls 8-13 years of age&#xD;
&#xD;
          -  Be overweight i.e. have a parent-reported BMI of at least +1 standard deviation above&#xD;
             the median according to the age and sex-standardized Danish growth curves&#xD;
&#xD;
          -  Be healthy&#xD;
&#xD;
          -  Like grain products and eat them daily&#xD;
&#xD;
          -  Speak Danish in order to understand the study procedures&#xD;
&#xD;
          -  At least one parent must read and speak Danish, in order to be properly informed about&#xD;
             the study procedures&#xD;
&#xD;
          -  Parents must have freezer capacity for 2 weeks bread provision&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy or intolerance to the study foods, including gluten&#xD;
&#xD;
          -  Use of dietary fiber supplements (e.g. HUSK) or probiotic supplements&#xD;
&#xD;
          -  Dieting or on a special diet&#xD;
&#xD;
          -  Serious chronic illnesses and diseases that may interfere with study outcomes&#xD;
&#xD;
          -  Use of medication that may affect study outcomes, including use of antibiotics the&#xD;
             last month&#xD;
&#xD;
          -  Concomitant participation in other studies involving dietary supplements, drugs or&#xD;
             blood sampling&#xD;
&#xD;
          -  Living in a household with another participating child&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Nutrition, Exercise and Sports, University of Copenhagen</name>
      <address>
        <city>Frederiksberg</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>May 6, 2021</last_update_submitted>
  <last_update_submitted_qc>May 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Copenhagen</investigator_affiliation>
    <investigator_full_name>Camilla Trab Damsgaard</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Children</keyword>
  <keyword>Wholegrain</keyword>
  <keyword>Cardiovascular risk markers</keyword>
  <keyword>Overweight</keyword>
  <keyword>Adolescents</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <!-- 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/NCT04430465
org study id: D225
nct id: NCT04430465
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
KORN investigates the effects of wholegrain oat and rye intake on health and cognitive
      wellbeing in children with overweight.
The purpose of KORN is to investigate the effects of wholegrain oat and rye intake on
      cardiometabolic health in slightly overweight 8-13-year-old children. Moreover, KORN aims to
      investigate effects on body weight and body composition, inflammatory markers,
      gastrointestinal wellbeing and cognitive function and explore the potential underlying
      mechanisms through assessment of changes in the children's gut microbiota as well as
      potential genotype-dependent and sex-specific effects.

      The study has a randomized controlled cross-over design. In two 8-week dietary periods the
      children will receive grain products (cereals, breads, pasta etc) with either high or low
      content of wholegrain from oat and rye in random order. Measurements and biological sampling
      will be performed at 0, 8 and 16 weeks.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
masking description: The intervention and data collection will be conducted unmasked. The data set will be masked before data analysis by staff not involved in the study.
measure: Low density lipoprotein cholesterol
time frame: 16 weeks
description: by fasting blood sample
measure: Insulin
time frame: 16 weeks
description: by fasting blood sample
measure: Height
time frame: 16 weeks
description: by stadiometer
measure: Weight
time frame: 16 weeks
description: by digital scale
measure: Body Mass Index z-score
time frame: 16 weeks
description: by height and weight measurements
measure: Waist circumference
time frame: 16 weeks
description: by measuring tape
measure: Fat mass index
time frame: 16 weeks
description: by Dual-energy X-ray Absorptiometry
measure: Fat free mass index
time frame: 16 weeks
description: by Dual-energy X-ray Absorptiometry
measure: Systolic blood pressure
time frame: 16 weeks
description: by digital device
measure: Diastolic blood pressure
time frame: 16 weeks
description: by digital device
measure: Heart rate
time frame: 16 weeks
description: by digital device
measure: Glucose
time frame: 16 weeks
description: by fasting blood sample
measure: Glycosylated hemoglobin (HbA1c)
time frame: 16 weeks
description: by fasting blood sample
measure: Triacylglycerol
time frame: 16 weeks
description: by fasting blood sample
measure: High density lipoprotein cholesterol
time frame: 16 weeks
description: by fasting blood sample
measure: Total cholesterol
time frame: 16 weeks
description: by fasting blood sample
measure: High sensitivity C-reactive protein
time frame: 16 weeks
description: by fasting blood sample
measure: Attention
time frame: 16 weeks
description: assessed by d2 test of attention
measure: Inhibition
time frame: 16 weeks
description: assessed by Stroop color and word test
measure: Processing speed
time frame: 16 weeks
description: assessed by d2 test of attention and Stroop color and word test
measure: Working memory
time frame: 16 weeks
description: assessed by Kim's game
measure: Socio-emotional skills
time frame: 16 weeks
description: assessed by parent reported Strengths and Difficulties Questionnaire
measure: Stool consistency
time frame: 16 weeks
description: assessed by the Bristol stool scale
measure: Gastrointestinal wellbeing
time frame: 16 weeks
description: assessed by questionnaire
measure: Prevalence of overweight
time frame: 16 weeks
description: By the International Obesity Task Force criteria
measure: Dietary intake
time frame: 16 weeks
description: assessed by 4-day dietary record
measure: Physical activity
time frame: 16 weeks
description: assessed by questionnaire
measure: Sociodemographic characteristics
time frame: at baseline
description: assessed by questionnaire
measure: Pubertal development stage
time frame: at baseline
description: assessed by the Tanner scales
measure: General satisfaction
time frame: 16 weeks
description: assessed by questionnaire
measure: Liking of study products
time frame: 16 weeks
description: assessed by questionnaire
measure: Alkylresorcinols (compliance)
time frame: 16 weeks
description: by fasting blood sample
measure: Android fat mass index
time frame: 16 weeks
description: by Dual-energy X-ray Absorptiometry
measure: Gynoid fat mass index
time frame: 16 weeks
description: by Dual-energy X-ray Absorptiometry
measure: Android:gynoid fat mass ratio
time frame: 16 weeks
description: by Dual-energy X-ray Absorptiometry
measure: Immune cell count
time frame: 16 weeks
description: by fasting blood sample
measure: Interleukin 6 (IL-6)
time frame: 16 weeks
description: by fasting blood sample
measure: Interleukin 1β (IL-1β)
time frame: 16 weeks
description: by fasting blood sample
measure: Tumor necrosis factor alpha (TNFα)
time frame: 16 weeks
description: by fasting blood sample
measure: Bone Mineral Density
time frame: 16 weeks
description: by Dual-energy X-ray Absorptiometry
measure: Bone Mineral Content
time frame: 16 weeks
description: by Dual-energy X-ray Absorptiometry
measure: Bone area
time frame: 16 weeks
description: by Dual-energy X-ray Absorptiometry
measure: Gut microbiome composition determined by high throughput sequencing and qPCR
time frame: 16 weeks
description: by fecal sample
measure: Short chain fatty acids
time frame: 16 weeks
description: by fasting blood sample
measure: Short chain fatty acids
time frame: 16 weeks
description: by fecal sample
measure: Bile acids
time frame: 16 weeks
description: by fasting blood sample
measure: Bile acids
time frame: 16 weeks
description: by fecal sample
measure: Fatty acid composition
time frame: 16 weeks
description: by fasting blood sample
measure: C-peptide
time frame: 16 weeks
description: by fasting blood sample
measure: Epigenetics
time frame: 16 weeks
description: by fasting blood sample
measure: Metabolomics
time frame: 16 weeks
description: by fasting blood sample
measure: Metabolomics
time frame: 16 weeks
description: by fecal sample
measure: Proteomics
time frame: 16 weeks
description: by fasting blood sample
measure: Proteomics
time frame: 16 weeks
description: by fecal sample
measure: Genotypes
time frame: 16 weeks
description: by fasting blood sample
measure: Adiponectin
time frame: 16 weeks
description: by fasting blood sample
measure: Leptin
time frame: 16 weeks
description: by fasting blood sample
measure: Appetite hormones
time frame: 16 weeks
description: by fasting blood sample
measure: Testosterone
time frame: 16 weeks
description: by fasting blood sample
measure: Estrogen
time frame: 16 weeks
description: by fasting blood sample
measure: Gonadotropins
time frame: 16 weeks
description: by fasting blood sample
arm group label: High wholegrain then low wholegrain
arm group type: Experimental
description: Starting with high wholegrain intervention followed by low wholegrain intervention
arm group label: Low wholegrain then high wholegrain
arm group type: Experimental
description: Starting with low wholegrain intervention followed by high wholegrain intervention
intervention type: Dietary Supplement
intervention name: Grain products high in wholegrains from oat and rye
description: A selection of grainproducts high in wholegrain from oat and rye, including cereals, bread, rolls, and pasta is replacing habitual grain products
arm group label: High wholegrain then low wholegrain
arm group label: Low wholegrain then high wholegrain
other name: Wholegrain
intervention type: Dietary Supplement
intervention name: Grain products low in wholegrains
description: A selection of grainproducts low in wholegrain, including cereals, bread, rolls, and pasta is replacing habitual grain products
arm group label: High wholegrain then low wholegrain
arm group label: Low wholegrain then high wholegrain
other name: Refined grain
criteria: 
gender: All
minimum age: 8 Years
maximum age: 13 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University of Copenhagen
investigator full name: Camilla Trab Damsgaard
investigator title: Associate Professor
mesh term: Overweight