<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/NCT02227511</url>
  </required_header>
  <id_info>
    <org_study_id>2014/170-31</org_study_id>
    <nct_id>NCT02227511</nct_id>
  </id_info>
  <brief_title>Prospective Randomized Trial of Fruits or Nuts Eaten Between Regular Meals in Healthy Subjects</brief_title>
  <official_title>Prospective Randomized Trial of Fruits or Nuts Eaten Between Regular Meals in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Linkoeping</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Linkoeping</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recruitment of 28 subjects that will be randomized to consume fruit or nuts as snacks between&#xD;
      regular meals for two months. Laboratory tests for cardiovascular risk factors, metabolic&#xD;
      rate, liver steatosis and physical activity are investigated ahead of start of the study and&#xD;
      at the end of the trial period och two months. Participants will be allowed to buy fruits or&#xD;
      nuts on their own but to keep track (diaries) of the amount consumed. They will be reimbursed&#xD;
      for the costs of the snacks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>amount of fat in the liver by magnetic resonance imaging</measure>
    <time_frame>two months</time_frame>
    <description>exact measurement of fat in the liver by liver spectroscopy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>cardiovascular risk factors</measure>
    <time_frame>two months</time_frame>
    <description>Collection of markers for cardiovascular risk including glucose, insulin, lipoproteins etc. Analyses will be performed from blood samples.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>fruit</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants are given +7kCal/kg body weight of fruit to be eaten as snack in between regular meals</description>
  </arm_group>
  <arm_group>
    <arm_group_label>nuts</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants are given +7kCal/kg body weight of nuts to be eaten as snack in between regular meals</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Fruits</intervention_name>
    <description>Randomization to extra fruit or nuts as snacks</description>
    <arm_group_label>fruit</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Nuts</intervention_name>
    <arm_group_label>nuts</arm_group_label>
    <other_name>Randomization to extra fruit or nuts as snacks</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy subjects&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  significant diseases that can affect outcomes, mental disorders that can affect&#xD;
             participation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>76 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fredrik H Nystrom</name>
      <address>
        <city>Linköping</city>
        <zip>58185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <last_update_submitted>May 13, 2016</last_update_submitted>
  <last_update_submitted_qc>May 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 16, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Linkoeping</investigator_affiliation>
    <investigator_full_name>Fredrik H Nystrom</investigator_full_name>
    <investigator_title>Professor, MD, Head of Internal Medicine</investigator_title>
  </responsible_party>
  <keyword>fruit, nuts, liver fat, insulin, glucose</keyword>
  <keyword>Focus of the study is to compare the often given advice to eat fruit, containing large amount of glucose and fructose, with nuts that are more rich in fat.</keyword>
  <!-- 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/NCT02227511
org study id: 2014/170-31
nct id: NCT02227511
lead sponsor: 
has dmc: No
Recruitment of 28 subjects that will be randomized to consume fruit or nuts as snacks between
      regular meals for two months. Laboratory tests for cardiovascular risk factors, metabolic
      rate, liver steatosis and physical activity are investigated ahead of start of the study and
      at the end of the trial period och two months. Participants will be allowed to buy fruits or
      nuts on their own but to keep track (diaries) of the amount consumed. They will be reimbursed
      for the costs of the snacks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: amount of fat in the liver by magnetic resonance imaging
time frame: two months
description: exact measurement of fat in the liver by liver spectroscopy
measure: cardiovascular risk factors
time frame: two months
description: Collection of markers for cardiovascular risk including glucose, insulin, lipoproteins etc. Analyses will be performed from blood samples.
arm group label: fruit
arm group type: Active Comparator
description: Participants are given +7kCal/kg body weight of fruit to be eaten as snack in between regular meals
arm group label: nuts
arm group type: Active Comparator
description: Participants are given +7kCal/kg body weight of nuts to be eaten as snack in between regular meals
intervention type: Dietary Supplement
intervention name: Fruits
description: Randomization to extra fruit or nuts as snacks
arm group label: fruit
intervention type: Dietary Supplement
intervention name: Nuts
arm group label: nuts
other name: Randomization to extra fruit or nuts as snacks
criteria: 
gender: All
minimum age: 18 Years
maximum age: 76 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Linkoeping
investigator full name: Fredrik H Nystrom
investigator title: Professor, MD, Head of Internal Medicine