<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/NCT03275948</url>
  </required_header>
  <id_info>
    <org_study_id>2016/487</org_study_id>
    <nct_id>NCT03275948</nct_id>
  </id_info>
  <brief_title>Effects of Whole Grain Rye on Metabolic Risk Markers and Mood</brief_title>
  <official_title>Effects of Whole Grain on Cognitive Performance and Mood, and the Relationships to Cardiometabolic Risk Markers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lund University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lund 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>
      The purpose of the study is to investigate, in healthy middle age subjects, effects of whole&#xD;
      grain rye on cognitive functions, mood, and cardiovasculair risk markers&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2016</start_date>
  <completion_date type="Actual">October 2, 2017</completion_date>
  <primary_completion_date type="Actual">February 28, 2017</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>cognitive performance</measure>
    <time_frame>postprandial 0-180 min after breakfast</time_frame>
    <description>test of working memory capacity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>glucose tolerance</measure>
    <time_frame>0-180 min after breakfast</time_frame>
    <description>postprandial glucose concentrations</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Metabolic Disorders and Cognitive Decline</condition>
  <arm_group>
    <arm_group_label>whole grain</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>refrence</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>white wheat based product</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>whole grain</intervention_name>
    <description>whole grain rye</description>
    <arm_group_label>whole grain</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>reference</intervention_name>
    <description>white wheat bread</description>
    <arm_group_label>refrence</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy&#xD;
&#xD;
          -  BMI 19-28&#xD;
&#xD;
          -  plasma glucose &lt; 6.1 mmol/L&#xD;
&#xD;
          -  non smooker&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known metabolic diseases&#xD;
&#xD;
          -  known gastrointestinal disorders&#xD;
&#xD;
          -  known cognitive decline.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>October 2, 2017</last_update_submitted>
  <last_update_submitted_qc>October 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lund University</investigator_affiliation>
    <investigator_full_name>Anne Nilsson</investigator_full_name>
    <investigator_title>Associate professor, PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Diseases</mesh_term>
    <mesh_term>Cognitive Dysfunction</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/NCT03275948
org study id: 2016/487
nct id: NCT03275948
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to investigate, in healthy middle age subjects, effects of whole
      grain rye on cognitive functions, mood, and cardiovasculair risk markers
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: cognitive performance
time frame: postprandial 0-180 min after breakfast
description: test of working memory capacity
measure: glucose tolerance
time frame: 0-180 min after breakfast
description: postprandial glucose concentrations
arm group label: whole grain
arm group type: Experimental
arm group label: refrence
arm group type: Other
description: white wheat based product
intervention type: Other
intervention name: whole grain
description: whole grain rye
arm group label: whole grain
intervention type: Other
intervention name: reference
description: white wheat bread
arm group label: refrence
criteria: 
gender: All
minimum age: 50 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Lund University
investigator full name: Anne Nilsson
investigator title: Associate professor, PhD
mesh term: Metabolic Diseases
mesh term: Cognitive Dysfunction
sharing ipd: No