xml: <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/NCT06032234</url>
    </required_header>
    <id_info>
      <org_study_id>VEGANScreenerCH</org_study_id>
      <nct_id>NCT06032234</nct_id>
    </id_info>
    <brief_title>Development and Evaluation of a Web-based Diet Quality Screener for Vegans (VEGANScreener)</brief_title>
    <acronym>VEGANScreener</acronym>
    <official_title>Development and Evaluation of a Web-based Diet Quality Screener for Vegans (VEGANScreener)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Isabelle Herter-Aeberli</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Berner Fachhochschule</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Swiss Federal Institute of Technology</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 primary objective of this study is to assess the construct validity and criterion&#xD;
        validity for associations of the VEGANScreener with nutrient intakes from reference methods&#xD;
        and associations with biomarkers of dietary intake. The investigators hypothesize that the&#xD;
        screener is a valid tool to assess diet quality in the vegan population. The study will&#xD;
        assess construct validity by testing whether the measure relates as it should to other&#xD;
        measures (e.g., age, gender, education, SES differences).&#xD;
  &#xD;
        The investigators will assess concurrent and predictive validity (types of criterion&#xD;
        validity) by evaluating associations and agreement between 'gold standards', such as diet&#xD;
        records, biomarkers, and multi-metabolite signatures of intake. The investigators will&#xD;
        examine associations of vegan diet quality with biomarkers of nutritional status, biomarkers&#xD;
        of disease, and anthropometric measures and hypothesize that a higher diet quality in vegans&#xD;
        is associated with a more favourable profile among vegans, for example, a lower blood&#xD;
        pressure. This study is part of the European VEGANScreener Consortium.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 12, 2023</start_date>
    <completion_date type="Anticipated">April 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 29, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Validity of the vegan screener</measure>
      <time_frame>Baseline</time_frame>
      <description>The validity will be assessed by calculating associations between the screener and reference method.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Dietary intake</measure>
      <time_frame>Baseline</time_frame>
      <description>Dietary intake will be assessed using a weighed food record</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Food habits</measure>
      <time_frame>Baseline</time_frame>
      <description>Food habits will be assessed using a food frequency questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Vitamin D status</measure>
      <time_frame>Baseline</time_frame>
      <description>Vitamin D status will be measured from venous blood samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Homocysteine status</measure>
      <time_frame>Baseline</time_frame>
      <description>Homocysteine will be measured from venous blood samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>holo-transcobalamin</measure>
      <time_frame>Baseline</time_frame>
      <description>holo-transcobalamin will be measured from venous blood samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Methoylmalonic acid</measure>
      <time_frame>Baseline</time_frame>
      <description>Methoylmalonic acid will be measured from venous blood samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Vitamin B2 status</measure>
      <time_frame>Baseline</time_frame>
      <description>Vitamin B2 will be measured from venous blood samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Vitamin C status</measure>
      <time_frame>Baseline</time_frame>
      <description>Vitamin C will be measured from venous blood samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Folic acid status</measure>
      <time_frame>Baseline</time_frame>
      <description>Folic acid will be measured from venous blood samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Magnesium status</measure>
      <time_frame>Baseline</time_frame>
      <description>Magnesium status will be determined from venous blood samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Zinc status</measure>
      <time_frame>Baseline</time_frame>
      <description>Zinc status will be determined from venous blood samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Selenoprotein-P status</measure>
      <time_frame>Baseline</time_frame>
      <description>Selenoprotein-P status will be determined from venous blood samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ferritin concentration</measure>
      <time_frame>Baseline</time_frame>
      <description>Ferritin concentration will be determined from venous blood samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Soluble transferrin receptor concentration</measure>
      <time_frame>Baseline</time_frame>
      <description>Soluble transferrin receptor will be determined from venous blood samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hemoglobin concentration</measure>
      <time_frame>Baseline</time_frame>
      <description>Hemoglobin will be determined from venous blood samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Creatinine concentration</measure>
      <time_frame>Baseline</time_frame>
      <description>Creatinine will be determined from venous blood samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Uric acid concentration</measure>
      <time_frame>Baseline</time_frame>
      <description>Uric acid will be determined from venous blood samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Urea concentration</measure>
      <time_frame>Baseline</time_frame>
      <description>Urea will be determined from urine samples samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Iodine concentration</measure>
      <time_frame>Baseline</time_frame>
      <description>Iodine status will be determined from urine samples samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Potassium concentration</measure>
      <time_frame>Baseline</time_frame>
      <description>Potassium status will be determined from urine samples samples iodine, potassium, sodium, calcium, creatinine)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sodium concentration</measure>
      <time_frame>Baseline</time_frame>
      <description>Sodium status will be determined from urine samples samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Calcium concentration</measure>
      <time_frame>Baseline</time_frame>
      <description>Calcium status will be determined from urine samples samples i</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Creatinine concentration</measure>
      <time_frame>Baseline</time_frame>
      <description>Creatinine will be determined from urine samples samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>C-reactive protein concentration</measure>
      <time_frame>Baseline</time_frame>
      <description>The inflammatory marker hsCRP will be determined from serum</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Triglyceride concentration</measure>
      <time_frame>Baseline</time_frame>
      <description>Triglyceride concentration will be determine from venous blood samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Free fatty acid concentration</measure>
      <time_frame>Baseline</time_frame>
      <description>Free fatty acid concentration will be determine from venous blood samples (</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Eicosapentanoic acid</measure>
      <time_frame>Baseline</time_frame>
      <description>Eicosapentanoic acid (in % of total FA) will be determine from venous blood samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Docosahexanoic acid</measure>
      <time_frame>Baseline</time_frame>
      <description>Docosahexanoic acid (in % of total FA) will be determine from venous blood samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>LDL-cholesterol concentration</measure>
      <time_frame>Baseline</time_frame>
      <description>LDL-cholesterol concentration will be determine from venous blood samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>HDL-Cholesterol concentration</measure>
      <time_frame>Baseline</time_frame>
      <description>HDL-Cholesterol concentration will be determine from venous blood samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cholesterol concentration</measure>
      <time_frame>Baseline</time_frame>
      <description>Cholesterol concentration will be determine from venous blood samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Glucose concentration</measure>
      <time_frame>Baseline</time_frame>
      <description>Glucose will be measured from venous blood samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Well being questionnaire</measure>
      <time_frame>Baseline</time_frame>
      <description>Participants well being will be assessed using a questionnaire. The scale of each question ranges from 0 to 10, 10 representing the highest well being</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>VEGANScreener</measure>
      <time_frame>Baseline and day 2</time_frame>
      <description>The VEGANScreener assesses diet quality using 29 questions of frequency of consumption of different foods and food groups.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Weight</measure>
      <time_frame>Baseline</time_frame>
      <description>Weight will be measured in kg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Height</measure>
      <time_frame>Baseline</time_frame>
      <description>Height will be measured in m</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Waist circumference</measure>
      <time_frame>Baseline</time_frame>
      <description>Waist circumference will be measured in cm</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hip circumference</measure>
      <time_frame>Baseline</time_frame>
      <description>Hip circumference will be measured in cm</description>
    </secondary_outcome>
    <other_outcome>
      <measure>International Physical Activity Questionnaire iPAQ</measure>
      <time_frame>Baseline</time_frame>
      <description>Physical activity will be assessed using a questionnaire using the iPAQ</description>
    </other_outcome>
    <other_outcome>
      <measure>Blood pressure</measure>
      <time_frame>Baseline</time_frame>
      <description>Systolic and diastolic blood pressure will be measured</description>
    </other_outcome>
    <other_outcome>
      <measure>Heart rate</measure>
      <time_frame>Baseline</time_frame>
      <description>Heart rate will be measured</description>
    </other_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>Omnivorous</arm_group_label>
      <description>Participants following an omniviours diet</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Vegan</arm_group_label>
      <description>Participants following a vegan diet</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>This is an observational study</intervention_name>
      <description>This is an observational study</description>
      <arm_group_label>Omnivorous</arm_group_label>
      <arm_group_label>Vegan</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Blood, urine and saliva samples will be collected&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Healthy participants following a vegan or omnivours diet (ratio 1:1).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Self-reported vegans (≥2 years on a vegan diet; vegan diet defined as not consuming&#xD;
               any dietary animal products more often than once/month, honey excluded)&#xD;
  &#xD;
            2. Self-reported omnivores. Consuming on average daily (at least 5 times/week) meat/meat&#xD;
               products.&#xD;
  &#xD;
            3. Age 18 to 65 years (1:1 ratio 18-35,99 and 36-65)&#xD;
  &#xD;
            4. Males and females (1:1 ratio)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Self-identified pescatarians (excluding all meat, except for fish/seafood) and&#xD;
               reductarians/flexitarians (intentionally reducing intake of animal-based products)&#xD;
  &#xD;
            2. History of a disease known to affect intermediary metabolism (e.g., any diabetes on&#xD;
               treatment, i.e. medication or lifestyle recommendations, thyreopathies, cancer etc.)&#xD;
  &#xD;
            3. BMI&gt;30 kg/m2&#xD;
  &#xD;
            4. History of disease of intestinal integrity (i.e., inflammatory bowel disease, chronic&#xD;
               pancreatitis, other malabsorption, etc.).&#xD;
  &#xD;
            5. Pregnant or breastfeeding females.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <gender_based>Yes</gender_based>
      <gender_description>An equal number of male and female participants will be included. Inclusion is based on self-representation of gender identity.</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Isabelle Herter, PhD</last_name>
      <phone>+41446327481</phone>
      <email>isabelle.herter@hest.ethz.ch</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Leonie H Bogl, PhD</last_name>
      <email>leonie-helen.bogl@bfh.ch</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Swiss Federal Institute of Technology</investigator_affiliation>
      <investigator_full_name>Isabelle Herter-Aeberli</investigator_full_name>
      <investigator_title>Principle Investigator</investigator_title>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06032234
  org study id: VEGANScreenerCH
  nct id: NCT06032234
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The primary objective of this study is to assess the construct validity and criterion
        validity for associations of the VEGANScreener with nutrient intakes from reference methods
        and associations with biomarkers of dietary intake. The investigators hypothesize that the
        screener is a valid tool to assess diet quality in the vegan population. The study will
        assess construct validity by testing whether the measure relates as it should to other
        measures (e.g., age, gender, education, SES differences).
  
        The investigators will assess concurrent and predictive validity (types of criterion
        validity) by evaluating associations and agreement between 'gold standards', such as diet
        records, biomarkers, and multi-metabolite signatures of intake. The investigators will
        examine associations of vegan diet quality with biomarkers of nutritional status, biomarkers
        of disease, and anthropometric measures and hypothesize that a higher diet quality in vegans
        is associated with a more favourable profile among vegans, for example, a lower blood
        pressure. This study is part of the European VEGANScreener Consortium.
  observational model: Cohort
  time perspective: Prospective
  measure: Validity of the vegan screener
  time frame: Baseline
  description: The validity will be assessed by calculating associations between the screener and reference method.
  measure: Dietary intake
  time frame: Baseline
  description: Dietary intake will be assessed using a weighed food record
  measure: Food habits
  time frame: Baseline
  description: Food habits will be assessed using a food frequency questionnaire
  measure: Vitamin D status
  time frame: Baseline
  description: Vitamin D status will be measured from venous blood samples
  measure: Homocysteine status
  time frame: Baseline
  description: Homocysteine will be measured from venous blood samples
  measure: holo-transcobalamin
  time frame: Baseline
  description: holo-transcobalamin will be measured from venous blood samples
  measure: Methoylmalonic acid
  time frame: Baseline
  description: Methoylmalonic acid will be measured from venous blood samples
  measure: Vitamin B2 status
  time frame: Baseline
  description: Vitamin B2 will be measured from venous blood samples
  measure: Vitamin C status
  time frame: Baseline
  description: Vitamin C will be measured from venous blood samples
  measure: Folic acid status
  time frame: Baseline
  description: Folic acid will be measured from venous blood samples
  measure: Magnesium status
  time frame: Baseline
  description: Magnesium status will be determined from venous blood samples
  measure: Zinc status
  time frame: Baseline
  description: Zinc status will be determined from venous blood samples
  measure: Selenoprotein-P status
  time frame: Baseline
  description: Selenoprotein-P status will be determined from venous blood samples
  measure: Ferritin concentration
  time frame: Baseline
  description: Ferritin concentration will be determined from venous blood samples
  measure: Soluble transferrin receptor concentration
  time frame: Baseline
  description: Soluble transferrin receptor will be determined from venous blood samples
  measure: Hemoglobin concentration
  time frame: Baseline
  description: Hemoglobin will be determined from venous blood samples
  measure: Creatinine concentration
  time frame: Baseline
  description: Creatinine will be determined from venous blood samples
  measure: Uric acid concentration
  time frame: Baseline
  description: Uric acid will be determined from venous blood samples
  measure: Urea concentration
  time frame: Baseline
  description: Urea will be determined from urine samples samples
  measure: Iodine concentration
  time frame: Baseline
  description: Iodine status will be determined from urine samples samples
  measure: Potassium concentration
  time frame: Baseline
  description: Potassium status will be determined from urine samples samples iodine, potassium, sodium, calcium, creatinine)
  measure: Sodium concentration
  time frame: Baseline
  description: Sodium status will be determined from urine samples samples
  measure: Calcium concentration
  time frame: Baseline
  description: Calcium status will be determined from urine samples samples i
  measure: Creatinine concentration
  time frame: Baseline
  description: Creatinine will be determined from urine samples samples
  measure: C-reactive protein concentration
  time frame: Baseline
  description: The inflammatory marker hsCRP will be determined from serum
  measure: Triglyceride concentration
  time frame: Baseline
  description: Triglyceride concentration will be determine from venous blood samples
  measure: Free fatty acid concentration
  time frame: Baseline
  description: Free fatty acid concentration will be determine from venous blood samples (
  measure: Eicosapentanoic acid
  time frame: Baseline
  description: Eicosapentanoic acid (in % of total FA) will be determine from venous blood samples
  measure: Docosahexanoic acid
  time frame: Baseline
  description: Docosahexanoic acid (in % of total FA) will be determine from venous blood samples
  measure: LDL-cholesterol concentration
  time frame: Baseline
  description: LDL-cholesterol concentration will be determine from venous blood samples
  measure: HDL-Cholesterol concentration
  time frame: Baseline
  description: HDL-Cholesterol concentration will be determine from venous blood samples
  measure: Cholesterol concentration
  time frame: Baseline
  description: Cholesterol concentration will be determine from venous blood samples
  measure: Glucose concentration
  time frame: Baseline
  description: Glucose will be measured from venous blood samples
  measure: Well being questionnaire
  time frame: Baseline
  description: Participants well being will be assessed using a questionnaire. The scale of each question ranges from 0 to 10, 10 representing the highest well being
  measure: VEGANScreener
  time frame: Baseline and day 2
  description: The VEGANScreener assesses diet quality using 29 questions of frequency of consumption of different foods and food groups.
  measure: Weight
  time frame: Baseline
  description: Weight will be measured in kg
  measure: Height
  time frame: Baseline
  description: Height will be measured in m
  measure: Waist circumference
  time frame: Baseline
  description: Waist circumference will be measured in cm
  measure: Hip circumference
  time frame: Baseline
  description: Hip circumference will be measured in cm
  measure: International Physical Activity Questionnaire iPAQ
  time frame: Baseline
  description: Physical activity will be assessed using a questionnaire using the iPAQ
  measure: Blood pressure
  time frame: Baseline
  description: Systolic and diastolic blood pressure will be measured
  measure: Heart rate
  time frame: Baseline
  description: Heart rate will be measured
  arm group label: Omnivorous
  description: Participants following an omniviours diet
  arm group label: Vegan
  description: Participants following a vegan diet
  intervention type: Other
  intervention name: This is an observational study
  description: This is an observational study
  arm group label: Omnivorous
  arm group label: Vegan
  Blood, urine and saliva samples will be collected
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  gender based: Yes
  gender description: An equal number of male and female participants will be included. Inclusion is based on self-representation of gender identity.
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Isabelle Herter, PhD
  phone: +41446327481
  email: isabelle.herter@hest.ethz.ch
  last name: Leonie H Bogl, PhD
  email: leonie-helen.bogl@bfh.ch
  responsible party type: Sponsor-Investigator
  investigator affiliation: Swiss Federal Institute of Technology
  investigator full name: Isabelle Herter-Aeberli
  investigator title: Principle Investigator