<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/NCT03823222</url>
  </required_header>
  <id_info>
    <org_study_id>NL66859.081.18</org_study_id>
    <nct_id>NCT03823222</nct_id>
  </id_info>
  <brief_title>Proteins From Duckweed Trial</brief_title>
  <acronym>ProDuckT</acronym>
  <official_title>Proteins From Duckweed Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wageningen University and Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wageningen University and Research</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>
      This study aims to study the digestibility of isolated duckweed protein. The digestibility of&#xD;
      the isolated duckweed protein will be compared to an isolated benchmark protein whey.&#xD;
&#xD;
      Objective: The primary objective is to investigate the digestibility of isolated duckweed&#xD;
      protein and the isolated benchmark protein whey.&#xD;
&#xD;
      Study design: The study is a cross-over, double blind, controlled trial in which study&#xD;
      participants will visit the research facility on two occasions under fasting conditions.&#xD;
      Subjects will receive two protein sources in randomized order with a washout period of one&#xD;
      week. Blood will be collected via a catheter before and up-to 3 hours after protein&#xD;
      consumption.&#xD;
&#xD;
      Study population: We aim to include 12 healthy volunteers aged 18-50 years. Intervention:&#xD;
      Study participants will receive 20 grams of isolated duckweed protein and the isolated&#xD;
      benchmark protein whey.&#xD;
&#xD;
      Main study parameters/endpoints: The main study parameter is blood amino acids measured&#xD;
      before and after consumption of 20 g protein.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 28, 2019</start_date>
  <completion_date type="Actual">March 28, 2019</completion_date>
  <primary_completion_date type="Actual">March 28, 2019</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>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in blood free amino acids (e.g. Degree of digestibility)</measure>
    <time_frame>20 gram protein will be consumed and blood samples will be taken before and up to 3 hours after protein consumption</time_frame>
    <description>postprandial test, determine free amino acids in blood samples collected before and after a postprandial challenge test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in plasma insulin</measure>
    <time_frame>20 gram protein will be consumed and blood samples will be taken before and up to 3 hours after protein consumption</time_frame>
    <description>before and after a postprandial challenge test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in plasma glucose</measure>
    <time_frame>20 gram protein will be consumed and blood samples will be taken before and up to 3 hours after protein consumption</time_frame>
    <description>before and after a postprandial challenge test</description>
  </secondary_outcome>
  <other_outcome>
    <measure>change in visual analogue scale (VAS) scores on intestinal complains</measure>
    <time_frame>daily from day1 until day3 after the intervention</time_frame>
    <description>On a scale ranging from worst-best outcome (higher scores are better)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Degree of Digestilbility</condition>
  <arm_group>
    <arm_group_label>Duckweed protein</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 gram of isolated protein</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Whey protein</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 gram of isolated protein</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Duckweed protein</intervention_name>
    <description>20 grams isolated protein</description>
    <arm_group_label>Duckweed protein</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Whey protein</intervention_name>
    <description>20 grams isolated protein</description>
    <arm_group_label>Whey protein</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body mass index (BMI) between 18 and 25 kg/m2&#xD;
&#xD;
          -  Having veins suitable for blood sampling via a catheter (judged by study nurse/&#xD;
             medical doctor)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any metabolic, gastrointestinal, inflammatory or chronic disease (such as diabetes,&#xD;
             anaemia, hepatitis, cardiovascular disease)&#xD;
&#xD;
          -  History of gastro-intestinal surgery or having (serious) gastro-intestinal complaints&#xD;
&#xD;
          -  History of liver dysfunction (cirrhosis, hepatitis) or liver surgery&#xD;
&#xD;
          -  Kidney dysfunction (self-reported)&#xD;
&#xD;
          -  Use of medication that may influence the study results, such as gastric acid&#xD;
             inhibitors, laxatives, stomach protectors and drugs that can affect intestinal&#xD;
             motility&#xD;
&#xD;
          -  Anaemia (Hb values &lt;7.5 for women and &lt;8.5 for men)&#xD;
&#xD;
          -  Reported slimming, medically prescribed, vegan/vegetarian or other extreme diets or&#xD;
             the use of protein supplements&#xD;
&#xD;
          -  Not willing to give up blood donation during the study&#xD;
&#xD;
          -  Current smokers&#xD;
&#xD;
          -  Alcohol intake ≥4 glasses of alcoholic beverages per day&#xD;
&#xD;
          -  Pregnant, lactating or wishing to become pregnant in the period of the study&#xD;
             (self-reported)&#xD;
&#xD;
          -  Abuse of illicit drugs&#xD;
&#xD;
          -  Food allergies for products that we use in the study&#xD;
&#xD;
          -  Participation in another clinical trial at the same time&#xD;
&#xD;
          -  Being an employee of the department Consumer Science &amp; Health group of Wageningen Food&#xD;
             &amp; Biobased Research&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Diederik Esser, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wageningen Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stichting Wageningen Research</name>
      <address>
        <city>Wageningen</city>
        <state>Gelderland</state>
        <zip>6708 WG</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>April 11, 2019</last_update_submitted>
  <last_update_submitted_qc>April 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wageningen University and Research</investigator_affiliation>
    <investigator_full_name>Diederik Esser</investigator_full_name>
    <investigator_title>project leader clinical trials</investigator_title>
  </responsible_party>
  <keyword>Duckweed protein</keyword>
  <keyword>protein</keyword>
  <keyword>degree of digestibility</keyword>
  <keyword>whey protein</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>will not be shared</ipd_description>
  </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/NCT03823222
org study id: NL66859.081.18
nct id: NCT03823222
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to study the digestibility of isolated duckweed protein. The digestibility of
      the isolated duckweed protein will be compared to an isolated benchmark protein whey.

      Objective: The primary objective is to investigate the digestibility of isolated duckweed
      protein and the isolated benchmark protein whey.

      Study design: The study is a cross-over, double blind, controlled trial in which study
      participants will visit the research facility on two occasions under fasting conditions.
      Subjects will receive two protein sources in randomized order with a washout period of one
      week. Blood will be collected via a catheter before and up-to 3 hours after protein
      consumption.

      Study population: We aim to include 12 healthy volunteers aged 18-50 years. Intervention:
      Study participants will receive 20 grams of isolated duckweed protein and the isolated
      benchmark protein whey.

      Main study parameters/endpoints: The main study parameter is blood amino acids measured
      before and after consumption of 20 g protein.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Change in blood free amino acids (e.g. Degree of digestibility)
time frame: 20 gram protein will be consumed and blood samples will be taken before and up to 3 hours after protein consumption
description: postprandial test, determine free amino acids in blood samples collected before and after a postprandial challenge test
measure: change in plasma insulin
time frame: 20 gram protein will be consumed and blood samples will be taken before and up to 3 hours after protein consumption
description: before and after a postprandial challenge test
measure: change in plasma glucose
time frame: 20 gram protein will be consumed and blood samples will be taken before and up to 3 hours after protein consumption
description: before and after a postprandial challenge test
measure: change in visual analogue scale (VAS) scores on intestinal complains
time frame: daily from day1 until day3 after the intervention
description: On a scale ranging from worst-best outcome (higher scores are better)
arm group label: Duckweed protein
arm group type: Experimental
description: 20 gram of isolated protein
arm group label: Whey protein
arm group type: Experimental
description: 20 gram of isolated protein
intervention type: Dietary Supplement
intervention name: Duckweed protein
description: 20 grams isolated protein
arm group label: Duckweed protein
intervention type: Dietary Supplement
intervention name: Whey protein
description: 20 grams isolated protein
arm group label: Whey protein
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Diederik Esser, PhD
role: Principal Investigator
affiliation: Wageningen Research
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Wageningen University and Research
investigator full name: Diederik Esser
investigator title: project leader clinical trials
sharing ipd: No
ipd description: will not be shared