<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/NCT03020225</url>
  </required_header>
  <id_info>
    <org_study_id>BenGurionU</org_study_id>
    <nct_id>NCT03020225</nct_id>
  </id_info>
  <brief_title>Protein Bioavailability of Wolffia Globosa (Mankai); Acute Test Meal Effects</brief_title>
  <acronym>Mankai</acronym>
  <official_title>Protein Bioavailability of Wolffia Globosa (Mankai); Acute Test Meal Effects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ben-Gurion University of the Negev</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Harvard School of Public Health (HSPH)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Leipzig</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ben-Gurion University of the Negev</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators aim to test the protein bioavailability of new specific developed strain of&#xD;
      duckweed [Wolffia globose, Mankai] , an aquatic plant, which might serve as a protein source&#xD;
      and contains all the 9 essential and the 6 conditional amino acids. The investigators will&#xD;
      randomize 36 participants to consume equivalent protein (30gr) content of 3 whole foods&#xD;
      items: 1. White cheese (animal protein source, as a reference); 2. Green peas, intact, cooked&#xD;
      (plant protein source); 3. Wolffia globosa (Mankai), intact, cooked (plant protein source).&#xD;
      The foods will be consumed in the morning, following 12h fasting. The foods will be provided&#xD;
      with 250ml mineral water and the blood follow-up frame will be for 3 hours. Primary outcome:&#xD;
      Blood amino acid profile.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators aim to test the protein bioavailability of new specific developed strain of&#xD;
      duckweed [Wolffia globose, Mankai], an aquatic plant, which might serve as a protein source&#xD;
      and contains all the 9 essential and the 6 conditional amino acids. &quot;Mankai&quot; [(Generally&#xD;
      recognized as safe (GRAS)] is a cultivated strain of Wolffia globosa, which is an aquatic&#xD;
      plant, part of the family of plants known commonly as duckweeds. Duckweeds are very simple&#xD;
      flowering aquatic plants which float on or just beneath the surface of still or slow-moving&#xD;
      bodies of water. There is a long history of the use of Wolffia species, in particular Wolffia&#xD;
      Globosa, as food, especially in Southeast Asia: Burma, Laos and northern Thailand, where it&#xD;
      has been used as a vegetable for many generations. There are numerous ways of W. globosa&#xD;
      consumption and a variety of recipes, using it either as a main ingredient (such as Wolffia&#xD;
      crisps or &quot;kaeng pum&quot; - a popular vegetable dish in northeastern Thailand) or incorporating&#xD;
      it in other foods (e.g. Wolffia-meat ball, fermented Wolffia-meat sausage, Wolffia rice&#xD;
      noodle, Wolffia cookies, Wolffia bread, and various soups and salads). Along with its long&#xD;
      history as a food source in Southeast Asia, it is recognized as an edible vegetable for&#xD;
      humans in several databases, including the United States Department of Agriculture (USDA&#xD;
      2014) GRIN database and a database dedicated to tropical species. The nutritional composition&#xD;
      of Mankai has been determined and found to be high in protein, containing all the essential&#xD;
      and conditionally essential amino acids, dietary fibers and several vitamins and minerals. In&#xD;
      a recent safety study, which aimed to test the safety of Mankai administration within and 3&#xD;
      times of the amount approved in the GRAS, 4 groups of female SD rats were orally administered&#xD;
      for 4 consecutive days a daily dose of Mankai at three dose levels of 1700, 2500 and&#xD;
      3400mg/kg of Mankai, equivalent to 20, 40 and 60 gr/day human dose, respectively. Clinical&#xD;
      (e.g body weight, food intake, morbidity/mortality, toxic signs), pathological (post mortem&#xD;
      gross pathology examination) and long list of blood biochemical indicators (e.g liver status&#xD;
      biomarkers, stress indicators, minerals) did not show any adverse effects. The results&#xD;
      indicate that repeated four day Mankai administration did not cause adverse effects.&#xD;
      Unexpectedly, high doses even suggested beneficial results with anti-glycemic effects. Mankai&#xD;
      was found to have a high digestibility profile (89%) according to Protein&#xD;
      digestibility-corrected amino acid score (PDCAAS) Eurofins tests. However, its human nutrient&#xD;
      bioavailability has not been examined yet. For the proposed test, Mankai (grown by Hinoman&#xD;
      Ltd., Israel) will be provided as a fresh, whole, product.&#xD;
&#xD;
      Methods: 36 men will be randomized to consume the following food items, which will be&#xD;
      equivalent to 30gr protein, after 12h night fasting:&#xD;
&#xD;
        1. Reference group: animal protein food source: White cheese, intact, plus 250ml mineral&#xD;
           water&#xD;
&#xD;
        2. Test group 1: plant food source: Green peas, intact, cooked, plus 250ml mineral water&#xD;
&#xD;
        3. Test group 2: plant food source: Wolffia globosa (Mankai), intact, cooked, plus 250ml&#xD;
           mineral water&#xD;
&#xD;
      The participants will be asked to maintain a stable diet (according to guidelines that will&#xD;
      be provided) for 3 days prior to the test meal. Blood samples will be taken at times 0, 30,&#xD;
      90, and 180 minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">February 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>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Amino Acid Profile (Blood Biomarkers)</measure>
    <time_frame>3 hours</time_frame>
    <description>will be analysed by metabolomic for amino acid profile (trajectory)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glycemic Profile</measure>
    <time_frame>3 hours</time_frame>
    <description>glucose (blood biomarkers)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipid Profile</measure>
    <time_frame>3 hours</time_frame>
    <description>HDL cholesterol fractions (blood biomarkers)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Liver Function</measure>
    <time_frame>3 hours</time_frame>
    <description>ALT (blood biomarkers)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minerals</measure>
    <time_frame>3 hours</time_frame>
    <description>potassium (blood measures)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vitamins</measure>
    <time_frame>3 hours</time_frame>
    <description>B12 (blood measures)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic Profile-Insulin</measure>
    <time_frame>3 hours</time_frame>
    <description>Insulin (blood biomarker)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglycerides</measure>
    <time_frame>3 hours</time_frame>
    <description>Triglycerides levels- Lipid profile</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Liver Enzymes- ASAT</measure>
    <time_frame>3 hours</time_frame>
    <description>ASAT - Liver enzymes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Magnesium</measure>
    <time_frame>3 hours</time_frame>
    <description>Magnesium levels</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Men With Mild Abdominal Obesity</condition>
  <arm_group>
    <arm_group_label>White cheese</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Reference group- animal protein food source: White cheese (contains 30g protein), intact, plus 250ml mineral water</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Green peas</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Plant food source: Green peas (contains 30g protein), intact, cooked, plus 250ml mineral water</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mankai</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Plant food source: Wolffia globosa (Mankai, contains 30g protein), intact, cooked, plus 250ml mineral water</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>White cheese</intervention_name>
    <description>animal protein food source: White cheese (contains 30g protein), intact, plus 250ml mineral water</description>
    <arm_group_label>White cheese</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Green peas</intervention_name>
    <description>Green peas (contains 30g protein), intact, cooked, plus 250ml mineral water</description>
    <arm_group_label>Green peas</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Mankai</intervention_name>
    <description>Wolffia globosa (Mankai, contains 30g protein), intact, cooked, plus 250ml mineral water</description>
    <arm_group_label>Mankai</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt;30 years; abdominal adiposity (waist circumference: men &gt; 102 cm, women &gt; 88 cm)&#xD;
             or dyslipidemia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  triglycerides&gt;400 mg/dL; serum creatinine&gt;2 mg/dL;&#xD;
&#xD;
          -  disturbed liver function;&#xD;
&#xD;
          -  pregnant or lactating women;&#xD;
&#xD;
          -  presence of active cancer, is receiving or received chemotherapy in the last three&#xD;
             years; participation in another trial;&#xD;
&#xD;
          -  participants who are treated with Coumadin (warfarin)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shai</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ben-Gurion University of the Negev</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>nuclear research center Negev</name>
      <address>
        <city>Dimona</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <results_first_submitted>March 17, 2021</results_first_submitted>
  <results_first_submitted_qc>January 31, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">April 5, 2022</results_first_posted>
  <last_update_submitted>January 31, 2022</last_update_submitted>
  <last_update_submitted_qc>January 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ben-Gurion University of the Negev</investigator_affiliation>
    <investigator_full_name>Iris Shai</investigator_full_name>
    <investigator_title>Principle investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity, Abdominal</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 9, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/25/NCT03020225/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>https://www.ncbi.nlm.nih.gov/pubmed/30591380</recruitment_details>
      <pre_assignment_details>https://www.ncbi.nlm.nih.gov/pubmed/30591380</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>White Cheese</title>
          <description>Reference group- animal protein food source: White cheese (contains 30g protein), intact, plus 250ml mineral water&#xD;
White cheese: animal protein food source: White cheese (contains 30g protein), intact, plus 250ml mineral water</description>
        </group>
        <group group_id="P2">
          <title>Green Peas</title>
          <description>Plant food source: Green peas (contains 30g protein), intact, cooked, plus 250ml mineral water&#xD;
Green peas: Green peas (contains 30g protein), intact, cooked, plus 250ml mineral water</description>
        </group>
        <group group_id="P3">
          <title>Mankai</title>
          <description>Plant food source: Wolffia globosa (Mankai, contains 30g protein), intact, cooked, plus 250ml mineral water&#xD;
Mankai: Wolffia globosa (Mankai, contains 30g protein), intact, cooked, plus 250ml mineral water</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>https://www.ncbi.nlm.nih.gov/pubmed/30591380</population>
      <group_list>
        <group group_id="B1">
          <title>White Cheese</title>
          <description>Reference group- animal protein food source: White cheese (contains 30g protein), intact, plus 250ml mineral water&#xD;
White cheese: animal protein food source: White cheese (contains 30g protein), intact, plus 250ml mineral water</description>
        </group>
        <group group_id="B2">
          <title>Green Peas</title>
          <description>Plant food source: Green peas (contains 30g protein), intact, cooked, plus 250ml mineral water&#xD;
Green peas: Green peas (contains 30g protein), intact, cooked, plus 250ml mineral water</description>
        </group>
        <group group_id="B3">
          <title>Mankai</title>
          <description>Plant food source: Wolffia globosa (Mankai, contains 30g protein), intact, cooked, plus 250ml mineral water&#xD;
Mankai: Wolffia globosa (Mankai, contains 30g protein), intact, cooked, plus 250ml mineral water</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
            <count group_id="B2" value="11"/>
            <count group_id="B3" value="13"/>
            <count group_id="B4" value="36"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                    <count group_id="B2" value="11"/>
                    <count group_id="B3" value="13"/>
                    <count group_id="B4" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48" spread="8.8"/>
                    <measurement group_id="B2" value="49.5" spread="12.1"/>
                    <measurement group_id="B3" value="48.9" spread="11"/>
                    <measurement group_id="B4" value="48.8" spread="10.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>number of man (%)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                    <count group_id="B2" value="11"/>
                    <count group_id="B3" value="13"/>
                    <count group_id="B4" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Israel</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                    <count group_id="B2" value="11"/>
                    <count group_id="B3" value="13"/>
                    <count group_id="B4" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Histidine (EAA)</title>
          <units>µmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                    <count group_id="B2" value="11"/>
                    <count group_id="B3" value="13"/>
                    <count group_id="B4" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.1" spread="4.1"/>
                    <measurement group_id="B2" value="31.3" spread="4.1"/>
                    <measurement group_id="B3" value="30" spread="2.9"/>
                    <measurement group_id="B4" value="30.7" spread="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Tryptophan (EAA)</title>
          <units>µmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                    <count group_id="B2" value="11"/>
                    <count group_id="B3" value="13"/>
                    <count group_id="B4" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14.2" spread="2.9"/>
                    <measurement group_id="B2" value="13.8" spread="3.5"/>
                    <measurement group_id="B3" value="12.4" spread="2.5"/>
                    <measurement group_id="B4" value="13.4" spread="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Phenylalanine (EAA)</title>
          <units>µmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                    <count group_id="B2" value="11"/>
                    <count group_id="B3" value="13"/>
                    <count group_id="B4" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.4" spread="13.5"/>
                    <measurement group_id="B2" value="60.3" spread="10.2"/>
                    <measurement group_id="B3" value="63.4" spread="8.5"/>
                    <measurement group_id="B4" value="63.8" spread="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Methionine (EAA)</title>
          <units>µmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                    <count group_id="B2" value="11"/>
                    <count group_id="B3" value="13"/>
                    <count group_id="B4" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.3" spread="7.4"/>
                    <measurement group_id="B2" value="25.6" spread="4.2"/>
                    <measurement group_id="B3" value="28.2" spread="6.1"/>
                    <measurement group_id="B4" value="28.1" spread="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Threonine (EAA)</title>
          <units>µmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                    <count group_id="B2" value="11"/>
                    <count group_id="B3" value="13"/>
                    <count group_id="B4" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.2" spread="6.7"/>
                    <measurement group_id="B2" value="29.9" spread="6.8"/>
                    <measurement group_id="B3" value="30.2" spread="5.7"/>
                    <measurement group_id="B4" value="30.5" spread="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Lysine (EAA)</title>
          <units>µmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                    <count group_id="B2" value="11"/>
                    <count group_id="B3" value="13"/>
                    <count group_id="B4" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="81" spread="24.9"/>
                    <measurement group_id="B2" value="73.2" spread="22.2"/>
                    <measurement group_id="B3" value="72.7" spread="19.5"/>
                    <measurement group_id="B4" value="75.6" spread="21.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Valine (EAA)</title>
          <units>µmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                    <count group_id="B2" value="11"/>
                    <count group_id="B3" value="13"/>
                    <count group_id="B4" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="187.1" spread="31.2"/>
                    <measurement group_id="B2" value="179.3" spread="36.3"/>
                    <measurement group_id="B3" value="184.4" spread="25"/>
                    <measurement group_id="B4" value="183.7" spread="30.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Isoleucine/leucine (EAA)</title>
          <units>µmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                    <count group_id="B2" value="11"/>
                    <count group_id="B3" value="13"/>
                    <count group_id="B4" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="141.8" spread="27.2"/>
                    <measurement group_id="B2" value="129" spread="26.6"/>
                    <measurement group_id="B3" value="139.7" spread="19.6"/>
                    <measurement group_id="B4" value="137.1" spread="24.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Amino Acid Profile (Blood Biomarkers)</title>
        <description>will be analysed by metabolomic for amino acid profile (trajectory)</description>
        <time_frame>3 hours</time_frame>
        <population>Essential amino acids (mmol/L) for the 3 groups</population>
        <group_list>
          <group group_id="O1">
            <title>White Cheese</title>
            <description>Essential amino acids (mmol/L)</description>
          </group>
          <group group_id="O2">
            <title>Green Peas</title>
            <description>Essential amino acids</description>
          </group>
          <group group_id="O3">
            <title>Mankai</title>
            <description>Essential amino acids</description>
          </group>
        </group_list>
        <measure>
          <title>Amino Acid Profile (Blood Biomarkers)</title>
          <description>will be analysed by metabolomic for amino acid profile (trajectory)</description>
          <population>Essential amino acids (mmol/L) for the 3 groups</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.1" spread="4.1"/>
                    <measurement group_id="O2" value="31.1" spread="4.1"/>
                    <measurement group_id="O3" value="30" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Glycemic Profile</title>
        <description>glucose (blood biomarkers)</description>
        <time_frame>3 hours</time_frame>
        <population>glucose</population>
        <group_list>
          <group group_id="O1">
            <title>White Cheese</title>
            <description>blood biomarkers of glycemia</description>
          </group>
          <group group_id="O2">
            <title>Green Peas</title>
            <description>blood biomarkers of glycemia</description>
          </group>
          <group group_id="O3">
            <title>Mankai</title>
            <description>blood biomarkers of glycemia</description>
          </group>
        </group_list>
        <measure>
          <title>Glycemic Profile</title>
          <description>glucose (blood biomarkers)</description>
          <population>glucose</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.5" spread="13.4"/>
                    <measurement group_id="O2" value="96" spread="9.2"/>
                    <measurement group_id="O3" value="96.7" spread="9.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lipid Profile</title>
        <description>HDL cholesterol fractions (blood biomarkers)</description>
        <time_frame>3 hours</time_frame>
        <population>cholesterol fractions</population>
        <group_list>
          <group group_id="O1">
            <title>White Cheese</title>
            <description>cholesterol fractions</description>
          </group>
          <group group_id="O2">
            <title>Green Peas</title>
            <description>cholesterol fractions</description>
          </group>
          <group group_id="O3">
            <title>Mankai</title>
            <description>cholesterol fractions</description>
          </group>
        </group_list>
        <measure>
          <title>Lipid Profile</title>
          <description>HDL cholesterol fractions (blood biomarkers)</description>
          <population>cholesterol fractions</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.3" spread="9.9"/>
                    <measurement group_id="O2" value="41.9" spread="9.3"/>
                    <measurement group_id="O3" value="44.4" spread="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Liver Function</title>
        <description>ALT (blood biomarkers)</description>
        <time_frame>3 hours</time_frame>
        <population>ALT</population>
        <group_list>
          <group group_id="O1">
            <title>Soft Cheese</title>
            <description>ALT measured in blood</description>
          </group>
          <group group_id="O2">
            <title>Green Peas</title>
            <description>ALT measured in blood</description>
          </group>
          <group group_id="O3">
            <title>Mankai</title>
            <description>ALT measured in blood</description>
          </group>
        </group_list>
        <measure>
          <title>Liver Function</title>
          <description>ALT (blood biomarkers)</description>
          <population>ALT</population>
          <units>U/l</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.2" spread="13.2"/>
                    <measurement group_id="O2" value="42.3" spread="21.1"/>
                    <measurement group_id="O3" value="46" spread="19.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Minerals</title>
        <description>potassium (blood measures)</description>
        <time_frame>3 hours</time_frame>
        <population>potassium</population>
        <group_list>
          <group group_id="O1">
            <title>White Cheese</title>
            <description>potassium levels</description>
          </group>
          <group group_id="O2">
            <title>Green Peas</title>
            <description>potassium levels</description>
          </group>
          <group group_id="O3">
            <title>Mankai</title>
            <description>potassium levels</description>
          </group>
        </group_list>
        <measure>
          <title>Minerals</title>
          <description>potassium (blood measures)</description>
          <population>potassium</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread="0.2"/>
                    <measurement group_id="O2" value="4.7" spread="0.3"/>
                    <measurement group_id="O3" value="4.5" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Vitamins</title>
        <description>B12 (blood measures)</description>
        <time_frame>3 hours</time_frame>
        <population>B12</population>
        <group_list>
          <group group_id="O1">
            <title>White Cheese</title>
            <description>Vitamin B12 (blood measures)</description>
          </group>
          <group group_id="O2">
            <title>Green Peas</title>
            <description>Vitamin B12 (blood measures)</description>
          </group>
          <group group_id="O3">
            <title>Mankai</title>
            <description>Vitamin B12 (blood measures)</description>
          </group>
        </group_list>
        <measure>
          <title>Vitamins</title>
          <description>B12 (blood measures)</description>
          <population>B12</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="371.1" spread="146.4"/>
                    <measurement group_id="O2" value="473" spread="144.1"/>
                    <measurement group_id="O3" value="423" spread="220.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Glycemic Profile-Insulin</title>
        <description>Insulin (blood biomarker)</description>
        <time_frame>3 hours</time_frame>
        <population>Insulin</population>
        <group_list>
          <group group_id="O1">
            <title>White Cheese</title>
            <description>blood biomarkers of glycemia</description>
          </group>
          <group group_id="O2">
            <title>Green Peas</title>
            <description>blood biomarkers of glycemia</description>
          </group>
          <group group_id="O3">
            <title>Mankai</title>
            <description>blood biomarkers of glycemia</description>
          </group>
        </group_list>
        <measure>
          <title>Glycemic Profile-Insulin</title>
          <description>Insulin (blood biomarker)</description>
          <population>Insulin</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.5" spread="13.4"/>
                    <measurement group_id="O2" value="96" spread="9.2"/>
                    <measurement group_id="O3" value="96.7" spread="9.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Triglycerides</title>
        <description>Triglycerides levels- Lipid profile</description>
        <time_frame>3 hours</time_frame>
        <population>Triglycerides</population>
        <group_list>
          <group group_id="O1">
            <title>White Cheese</title>
            <description>Triglycerides</description>
          </group>
          <group group_id="O2">
            <title>Green Peas</title>
            <description>Triglycerides</description>
          </group>
          <group group_id="O3">
            <title>Mankai</title>
            <description>Triglycerides</description>
          </group>
        </group_list>
        <measure>
          <title>Triglycerides</title>
          <description>Triglycerides levels- Lipid profile</description>
          <population>Triglycerides</population>
          <units>mg/dl</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="172.2" spread="77"/>
                    <measurement group_id="O2" value="198" spread="111.7"/>
                    <measurement group_id="O3" value="207.9" spread="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Liver Enzymes- ASAT</title>
        <description>ASAT - Liver enzymes</description>
        <time_frame>3 hours</time_frame>
        <population>ASAT</population>
        <group_list>
          <group group_id="O1">
            <title>Soft Cheese</title>
            <description>ASATmeasured in blood</description>
          </group>
          <group group_id="O2">
            <title>Green Peas</title>
            <description>ASATmeasured in blood</description>
          </group>
          <group group_id="O3">
            <title>Mankai</title>
            <description>ASAT measured in blood</description>
          </group>
        </group_list>
        <measure>
          <title>Liver Enzymes- ASAT</title>
          <description>ASAT - Liver enzymes</description>
          <population>ASAT</population>
          <units>μKat/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.53" spread="0.09"/>
                    <measurement group_id="O2" value="0.49" spread="0.09"/>
                    <measurement group_id="O3" value="0.51" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Magnesium</title>
        <description>Magnesium levels</description>
        <time_frame>3 hours</time_frame>
        <population>Magnesium levels</population>
        <group_list>
          <group group_id="O1">
            <title>White Cheese</title>
            <description>Magnesium levels</description>
          </group>
          <group group_id="O2">
            <title>Green Peas</title>
            <description>Magnesium levels</description>
          </group>
          <group group_id="O3">
            <title>Mankai</title>
            <description>Magnesium levels</description>
          </group>
        </group_list>
        <measure>
          <title>Magnesium</title>
          <description>Magnesium levels</description>
          <population>Magnesium levels</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.87" spread="0.072"/>
                    <measurement group_id="O2" value="0.95" spread="0.28"/>
                    <measurement group_id="O3" value="0.91" spread="0.054"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 hours</time_frame>
      <group_list>
        <group group_id="E1">
          <title>White Cheese</title>
          <description>Reference group- animal protein food source: White cheese (contains 30g protein), intact, plus 250ml mineral water&#xD;
White cheese: animal protein food source: White cheese (contains 30g protein), intact, plus 250ml mineral water</description>
        </group>
        <group group_id="E2">
          <title>Green Peas</title>
          <description>Plant food source: Green peas (contains 30g protein), intact, cooked, plus 250ml mineral water&#xD;
Green peas: Green peas (contains 30g protein), intact, cooked, plus 250ml mineral water</description>
        </group>
        <group group_id="E3">
          <title>Mankai</title>
          <description>Plant food source: Wolffia globosa (Mankai, contains 30g protein), intact, cooked, plus 250ml mineral water&#xD;
Mankai: Wolffia globosa (Mankai, contains 30g protein), intact, cooked, plus 250ml mineral water</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Prof. Iris Shai</name_or_title>
      <organization>BGU</organization>
      <phone>+972 52-579-3040</phone>
      <email>irish@bgu.ac.il</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03020225
org study id: BenGurionU
nct id: NCT03020225
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The investigators aim to test the protein bioavailability of new specific developed strain of
      duckweed [Wolffia globose, Mankai] , an aquatic plant, which might serve as a protein source
      and contains all the 9 essential and the 6 conditional amino acids. The investigators will
      randomize 36 participants to consume equivalent protein (30gr) content of 3 whole foods
      items: 1. White cheese (animal protein source, as a reference); 2. Green peas, intact, cooked
      (plant protein source); 3. Wolffia globosa (Mankai), intact, cooked (plant protein source).
      The foods will be consumed in the morning, following 12h fasting. The foods will be provided
      with 250ml mineral water and the blood follow-up frame will be for 3 hours. Primary outcome:
      Blood amino acid profile.
The investigators aim to test the protein bioavailability of new specific developed strain of
      duckweed [Wolffia globose, Mankai], an aquatic plant, which might serve as a protein source
      and contains all the 9 essential and the 6 conditional amino acids. "Mankai" [(Generally
      recognized as safe (GRAS)] is a cultivated strain of Wolffia globosa, which is an aquatic
      plant, part of the family of plants known commonly as duckweeds. Duckweeds are very simple
      flowering aquatic plants which float on or just beneath the surface of still or slow-moving
      bodies of water. There is a long history of the use of Wolffia species, in particular Wolffia
      Globosa, as food, especially in Southeast Asia: Burma, Laos and northern Thailand, where it
      has been used as a vegetable for many generations. There are numerous ways of W. globosa
      consumption and a variety of recipes, using it either as a main ingredient (such as Wolffia
      crisps or "kaeng pum" - a popular vegetable dish in northeastern Thailand) or incorporating
      it in other foods (e.g. Wolffia-meat ball, fermented Wolffia-meat sausage, Wolffia rice
      noodle, Wolffia cookies, Wolffia bread, and various soups and salads). Along with its long
      history as a food source in Southeast Asia, it is recognized as an edible vegetable for
      humans in several databases, including the United States Department of Agriculture (USDA
      2014) GRIN database and a database dedicated to tropical species. The nutritional composition
      of Mankai has been determined and found to be high in protein, containing all the essential
      and conditionally essential amino acids, dietary fibers and several vitamins and minerals. In
      a recent safety study, which aimed to test the safety of Mankai administration within and 3
      times of the amount approved in the GRAS, 4 groups of female SD rats were orally administered
      for 4 consecutive days a daily dose of Mankai at three dose levels of 1700, 2500 and
      3400mg/kg of Mankai, equivalent to 20, 40 and 60 gr/day human dose, respectively. Clinical
      (e.g body weight, food intake, morbidity/mortality, toxic signs), pathological (post mortem
      gross pathology examination) and long list of blood biochemical indicators (e.g liver status
      biomarkers, stress indicators, minerals) did not show any adverse effects. The results
      indicate that repeated four day Mankai administration did not cause adverse effects.
      Unexpectedly, high doses even suggested beneficial results with anti-glycemic effects. Mankai
      was found to have a high digestibility profile (89%) according to Protein
      digestibility-corrected amino acid score (PDCAAS) Eurofins tests. However, its human nutrient
      bioavailability has not been examined yet. For the proposed test, Mankai (grown by Hinoman
      Ltd., Israel) will be provided as a fresh, whole, product.

      Methods: 36 men will be randomized to consume the following food items, which will be
      equivalent to 30gr protein, after 12h night fasting:

        1. Reference group: animal protein food source: White cheese, intact, plus 250ml mineral
           water

        2. Test group 1: plant food source: Green peas, intact, cooked, plus 250ml mineral water

        3. Test group 2: plant food source: Wolffia globosa (Mankai), intact, cooked, plus 250ml
           mineral water

      The participants will be asked to maintain a stable diet (according to guidelines that will
      be provided) for 3 days prior to the test meal. Blood samples will be taken at times 0, 30,
      90, and 180 minutes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Amino Acid Profile (Blood Biomarkers)
time frame: 3 hours
description: will be analysed by metabolomic for amino acid profile (trajectory)
measure: Glycemic Profile
time frame: 3 hours
description: glucose (blood biomarkers)
measure: Lipid Profile
time frame: 3 hours
description: HDL cholesterol fractions (blood biomarkers)
measure: Liver Function
time frame: 3 hours
description: ALT (blood biomarkers)
measure: Minerals
time frame: 3 hours
description: potassium (blood measures)
measure: Vitamins
time frame: 3 hours
description: B12 (blood measures)
measure: Glycemic Profile-Insulin
time frame: 3 hours
description: Insulin (blood biomarker)
measure: Triglycerides
time frame: 3 hours
description: Triglycerides levels- Lipid profile
measure: Liver Enzymes- ASAT
time frame: 3 hours
description: ASAT - Liver enzymes
measure: Magnesium
time frame: 3 hours
description: Magnesium levels
arm group label: White cheese
arm group type: Active Comparator
description: Reference group- animal protein food source: White cheese (contains 30g protein), intact, plus 250ml mineral water
arm group label: Green peas
arm group type: Experimental
description: Plant food source: Green peas (contains 30g protein), intact, cooked, plus 250ml mineral water
arm group label: Mankai
arm group type: Experimental
description: Plant food source: Wolffia globosa (Mankai, contains 30g protein), intact, cooked, plus 250ml mineral water
intervention type: Dietary Supplement
intervention name: White cheese
description: animal protein food source: White cheese (contains 30g protein), intact, plus 250ml mineral water
arm group label: White cheese
intervention type: Dietary Supplement
intervention name: Green peas
description: Green peas (contains 30g protein), intact, cooked, plus 250ml mineral water
arm group label: Green peas
intervention type: Dietary Supplement
intervention name: Mankai
description: Wolffia globosa (Mankai, contains 30g protein), intact, cooked, plus 250ml mineral water
arm group label: Mankai
criteria: 
gender: Male
minimum age: 30 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Shai
role: Principal Investigator
affiliation: Ben-Gurion University of the Negev
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Ben-Gurion University of the Negev
investigator full name: Iris Shai
investigator title: Principle investigator
mesh term: Obesity, Abdominal
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 