<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/NCT03794141</url>
  </required_header>
  <id_info>
    <org_study_id>41007-00040400</org_study_id>
    <nct_id>NCT03794141</nct_id>
  </id_info>
  <brief_title>Genetic Information as a Life Style Change Motivator</brief_title>
  <acronym>APOE4MOT</acronym>
  <official_title>Effects of ApoE4 Genotype Information and Intervention Intensity on the Fulfillment of Lifestyle Changes and Sensory Preferences</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Natural Resources Institute Finland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Turku</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Eastern Finland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Academy of Finland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Natural Resources Institute Finland</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study investigates whether information on having a risk genotype (ApoE4) and life style&#xD;
      advisory information affects lifestyle changes and sensory preferences. The project studies&#xD;
      also the ethic aspects of giving the information of risk genotype.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We will run intervention based on our earlier pilot study. It includes intensive intervention&#xD;
      and a modification of our earlier pilot intervention. Our intervention methods are general&#xD;
      lectures of the effects of healthy diet (Finnish Nutrition Recommendations 2014) and healthy&#xD;
      lifestyle for all participants. Effects on motivation, attitudes and preferences will be&#xD;
      studied and verified by questionnaires and risk factors of cardiovascular disease and&#xD;
      Alzheimer disease by analyzing clinical markers of lipid metabolism, general phenotype&#xD;
      markers and profiles of nutritional markers. Nutritional biomarkers will verify also the&#xD;
      self-reported changes of diet in the questionnaires and in digital food diaries.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2017</start_date>
  <completion_date type="Actual">July 31, 2019</completion_date>
  <primary_completion_date type="Actual">March 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with good quality of dietary fat</measure>
    <time_frame>2 years</time_frame>
    <description>A questionnaire according to Finnish guidelines of Suomen Sydänliitto ry, Helldán &amp; Helakorpi, (2015)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dietary habits, number of participants</measure>
    <time_frame>2 years</time_frame>
    <description>A questionnaire asking for&#xD;
Fish intake at least twice per week&#xD;
Consumption of high fat and sugar foods&#xD;
Consumption of vegetables&#xD;
Alcohol consumption&#xD;
Physical activity at least twice per week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Food choice questionnaire, health and taste attitude</measure>
    <time_frame>2 years</time_frame>
    <description>Scale 1-7 (7 most important, fully agree)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Food involvement and Food mavenism, scale 1-5</measure>
    <time_frame>2 years</time_frame>
    <description>5 fully agree</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Health concern, scale 1-9</measure>
    <time_frame>2 years</time_frame>
    <description>1 not concerned at all</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Life-orientation test, scale 1-5</measure>
    <time_frame>2 years</time_frame>
    <description>1 fully agree</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Locus of Control, state-trait anxiety inventory, Three-Factor Eating Questionnaire (TFEQ) scale 1-4</measure>
    <time_frame>2 years</time_frame>
    <description>4 fully agree</description>
  </primary_outcome>
  <primary_outcome>
    <measure>weight kg</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>height m</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Waist circumference, cm</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Visceral fat level (1-30)</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>blood pressure, mmHg</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum lipid levels mmol/L</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood glucose levels, mmol/L</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum lipid peroxidation, MDA/µM</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum Sensitive C reactive protein, mg/L</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum Hemoglobin, g/L</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum Alkaline phosphatase, U/L</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum Alanine aminotransferase, U/L</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum haptoglobin, g/L</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma thyrotropin, mU/L</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>serum APOE protein, mg/L</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>serum brain-derived neurotrophic factor, ng/ml</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>serum Fatty acids, g/100g fatty acids</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>serum Carotenoids, retinol and α-tocopherol, Plasma total phenolics ng/µl</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood cell count</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>APOE and BDNF genotype</measure>
    <time_frame>baseline</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body mass index</measure>
    <time_frame>2 years</time_frame>
    <description>weight and height will be combined to report BMI in kg/m^2</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">333</enrollment>
  <condition>Health Behavior</condition>
  <condition>Alzheimer Disease, Protection Against</condition>
  <arm_group>
    <arm_group_label>Tervas</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Follow up group from an earlier study. Information on risk gene status. All test persons were given information on healthy diet and life style.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Informed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Information on risk gene status was given before intervention. All test persons were given information on healthy diet and life style.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non informed</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Information on risk gene status was not given before intervention. All test persons were given information on healthy diet and life style.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>information on the risk gene status</intervention_name>
    <description>information on risk gene status (APOE4 allele or not) was given before intervention</description>
    <arm_group_label>Informed</arm_group_label>
    <arm_group_label>Tervas</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>life style advise</intervention_name>
    <description>all test persons were given information on healthy diet and life style</description>
    <arm_group_label>Informed</arm_group_label>
    <arm_group_label>Tervas</arm_group_label>
    <arm_group_label>non informed</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 40 and 60 years&#xD;
&#xD;
          -  overall good health (no chronic conditions e.g. mental disorders, cancer, liver or&#xD;
             kidney disease, current or previous diagnosis),&#xD;
&#xD;
          -  body mass index (BMI) under 35 kg/m2,&#xD;
&#xD;
          -  blood pressure under 140/90 mmHg (medication allowed),&#xD;
&#xD;
          -  serum total cholesterol under 7.25 mmol/l (medication allowed)&#xD;
&#xD;
          -  fasting plasma glucose level under 7 mmol/l.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Abnormal values of the alanine amino transferase, alkaline phosphatase, haptoglobin&#xD;
             and thyroid stimulating hormone&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raija Tahvonen, Prof</last_name>
    <role>Study Director</role>
    <affiliation>Natural Resources Institute Finland</affiliation>
  </overall_official>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>February 25, 2020</last_update_submitted>
  <last_update_submitted_qc>February 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</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/NCT03794141
org study id: 41007-00040400
nct id: NCT03794141
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The study investigates whether information on having a risk genotype (ApoE4) and life style
      advisory information affects lifestyle changes and sensory preferences. The project studies
      also the ethic aspects of giving the information of risk genotype.
We will run intervention based on our earlier pilot study. It includes intensive intervention
      and a modification of our earlier pilot intervention. Our intervention methods are general
      lectures of the effects of healthy diet (Finnish Nutrition Recommendations 2014) and healthy
      lifestyle for all participants. Effects on motivation, attitudes and preferences will be
      studied and verified by questionnaires and risk factors of cardiovascular disease and
      Alzheimer disease by analyzing clinical markers of lipid metabolism, general phenotype
      markers and profiles of nutritional markers. Nutritional biomarkers will verify also the
      self-reported changes of diet in the questionnaires and in digital food diaries.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of participants with good quality of dietary fat
time frame: 2 years
description: A questionnaire according to Finnish guidelines of Suomen Sydänliitto ry, Helldán & Helakorpi, (2015)
measure: Dietary habits, number of participants
time frame: 2 years
description: A questionnaire asking for
Fish intake at least twice per week
Consumption of high fat and sugar foods
Consumption of vegetables
Alcohol consumption
Physical activity at least twice per week
measure: Food choice questionnaire, health and taste attitude
time frame: 2 years
description: Scale 1-7 (7 most important, fully agree)
measure: Food involvement and Food mavenism, scale 1-5
time frame: 2 years
description: 5 fully agree
measure: Health concern, scale 1-9
time frame: 2 years
description: 1 not concerned at all
measure: Life-orientation test, scale 1-5
time frame: 2 years
description: 1 fully agree
measure: Locus of Control, state-trait anxiety inventory, Three-Factor Eating Questionnaire (TFEQ) scale 1-4
time frame: 2 years
description: 4 fully agree
measure: weight kg
time frame: 2 years
measure: height m
time frame: 2 years
measure: Waist circumference, cm
time frame: 2 years
measure: Visceral fat level (1-30)
time frame: 2 years
measure: blood pressure, mmHg
time frame: 2 years
measure: Serum lipid levels mmol/L
time frame: 2 years
measure: Blood glucose levels, mmol/L
time frame: 2 years
measure: Serum lipid peroxidation, MDA/µM
time frame: 2 years
measure: Serum Sensitive C reactive protein, mg/L
time frame: 2 years
measure: Serum Hemoglobin, g/L
time frame: 2 years
measure: Serum Alkaline phosphatase, U/L
time frame: 2 years
measure: Serum Alanine aminotransferase, U/L
time frame: 2 years
measure: Serum haptoglobin, g/L
time frame: 2 years
measure: Plasma thyrotropin, mU/L
time frame: 2 years
measure: serum APOE protein, mg/L
time frame: 2 years
measure: serum brain-derived neurotrophic factor, ng/ml
time frame: 2 years
measure: serum Fatty acids, g/100g fatty acids
time frame: 2 years
measure: serum Carotenoids, retinol and α-tocopherol, Plasma total phenolics ng/µl
time frame: 2 years
measure: Blood cell count
time frame: 2 years
measure: APOE and BDNF genotype
time frame: baseline
measure: Body mass index
time frame: 2 years
description: weight and height will be combined to report BMI in kg/m^2
arm group label: Tervas
arm group type: Experimental
description: Follow up group from an earlier study. Information on risk gene status. All test persons were given information on healthy diet and life style.
arm group label: Informed
arm group type: Experimental
description: Information on risk gene status was given before intervention. All test persons were given information on healthy diet and life style.
arm group label: non informed
arm group type: Active Comparator
description: Information on risk gene status was not given before intervention. All test persons were given information on healthy diet and life style.
intervention type: Behavioral
intervention name: information on the risk gene status
description: information on risk gene status (APOE4 allele or not) was given before intervention
arm group label: Informed
arm group label: Tervas
intervention type: Behavioral
intervention name: life style advise
description: all test persons were given information on healthy diet and life style
arm group label: Informed
arm group label: Tervas
arm group label: non informed
criteria: 
gender: All
minimum age: 40 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Raija Tahvonen, Prof
role: Study Director
affiliation: Natural Resources Institute Finland
responsible party type: Sponsor
mesh term: Alzheimer Disease
sharing ipd: No