<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/NCT03019458</url>
  </required_header>
  <id_info>
    <org_study_id>MINGO-001</org_study_id>
    <nct_id>NCT03019458</nct_id>
  </id_info>
  <brief_title>MINGO Supplemental Trial in X-linked Dystonia-Parkinsonism Patients</brief_title>
  <acronym>MINGO</acronym>
  <official_title>MINGO Supplemental Trial in X-linked Dystonia Parkinsonism Patients: A Prospective Randomized, Open-labeled, Parallel Group Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sunshine Care Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jose R. Reyes Memorial Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sunshine Care Foundation</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>
      To see whether MINGO, a food supplement, will be able to lessen the drastic weight loss seen&#xD;
      among X-linked Dystonia Parkinsonism patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      X-linked dystonia parkinsonism (XDP, formerly known as DYT3) occurs primarily in Filipino&#xD;
      males and is characterized by neurodegenerative dystonia and parkinsonism. It is currently&#xD;
      recognized to have wide phenotypic variability relating to age of onset, location of disease&#xD;
      onset and rate of severity/disease progression. Most patients begin with focal dystonia that&#xD;
      generalizes with the development of parkinsonism later in disease course. XDP patients suffer&#xD;
      from severe nutritional loss due to symptoms such as dysphagia, loss of appetite, and&#xD;
      consistently high metabolic requirements brought about by their movement disorder.&#xD;
      Approximately 79% of patients with XDP have experienced rapid weight loss since the onset of&#xD;
      their disease. It is the aim of the researchers to assess the clinical usefulness of adding a&#xD;
      nutritional supplement to the daily dietary needs of these patients.&#xD;
&#xD;
      MINGO is a supplement consisting of local ingredients such as moringa, rice and mung beans,&#xD;
      which can be added to any type of edible paste, food, and liquid. Mingo has gained popularity&#xD;
      as an emergency food in disaster relief operations due to the ease of its preparation, its&#xD;
      high nutritional value and relatively low price. For the last two years, it has also been&#xD;
      used as an agent for nutritional build up in malnourished populations of children. This study&#xD;
      will provide valuable information on whether patients with XDP can increase their weight by&#xD;
      consuming MINGO, which will lead to improvements in the patients' medical care and wellbeing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 10, 2017</start_date>
  <completion_date type="Actual">June 26, 2017</completion_date>
  <primary_completion_date type="Actual">May 8, 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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Body Mass Index (BMI in kg/m^2) Using a Bathroom Weighing Scale.</measure>
    <time_frame>after baseline Body Mass Index, we will measure Body Mass Index every 2 weeks for 3 months</time_frame>
    <description>The investigators will first take a baseline Body Mass Index in kg/m^2 for both control and intervention group, then subsequent measures every two weeks for 3 month duration of he trial. The goal of the investigators is to compare the net change in Body Mass Index in a 3 month period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All Cause Mortality</measure>
    <time_frame>3 months (study close out)</time_frame>
    <description>number of deaths in both arms at the end of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Hospitalizations Secondary to Infectious Causes</measure>
    <time_frame>3 months (study close out)</time_frame>
    <description>number of hospitalizations secondary to infections in both arms at the end of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mid Upper Arm Circumference (MUAC) in cm Using a Tailor's Tape Measure</measure>
    <time_frame>After baseline measurements, the investigators will measure the MUAC evey month for 3 months</time_frame>
    <description>It has been reported that the Mid Upper Arm Circumference is a good predictor for BMI. It will serve as an indirect measurement to the subjects' BMI</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>X-Linked Dystonia Parkinsonism</condition>
  <arm_group>
    <arm_group_label>MINGO</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MINGO is a supplement consisting of local ingredients such as moringa, rice and mung beans, which can be added to any type of edible paste, food, and liquid. The experimental group is required to take 6 sachets per day for 12 weeks in addition to their regular diet. They are required to keep a daily food diary</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group is required to eat their normal diet. They are also required to keep a daily food diary.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>MINGO</intervention_name>
    <description>6 20oz sachets will be taken daily by intervention group</description>
    <arm_group_label>MINGO</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is above the age of 18&#xD;
&#xD;
          -  Positive Diagnosis of XDP by movement disorder specialist/fellow&#xD;
&#xD;
          -  Subject with a yes response to a &quot;supportive home environment&quot; in the patient's most&#xD;
             recent &quot;doctors monthly report&quot;&#xD;
&#xD;
          -  Subject are easily accessible to passable roads and pubic transportation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who have extreme movements that prevent staff from performing BMI or MUAC&#xD;
             measurements&#xD;
&#xD;
          -  Subjects who have abnormal metabolic labs prior to the start of the study&#xD;
&#xD;
          -  Subjects who are taking pharmacological or medicinal supplements that may effect&#xD;
             weight&#xD;
&#xD;
          -  Subjects who have been hospitalized within the last 2 weeks from the start of the&#xD;
             trial&#xD;
&#xD;
          -  Subjects who have a Nasogastric tube or G-tube&#xD;
&#xD;
          -  Subjects with a history of other diseases that my effect weight (eg:&#xD;
             hypo/hyperthyroidism)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Criscely L Go, MD,FPNA,DPBP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jose R. Reyes Memorial Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Health Centrum</name>
      <address>
        <city>Roxas City</city>
        <state>Capiz</state>
        <zip>5800</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Philippines</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <results_first_submitted>December 7, 2017</results_first_submitted>
  <results_first_submitted_qc>March 20, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">April 6, 2020</results_first_posted>
  <last_update_submitted>April 20, 2020</last_update_submitted>
  <last_update_submitted_qc>April 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prospective randomized trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dystonia</mesh_term>
    <mesh_term>Dystonic Disorders</mesh_term>
    <mesh_term>Parkinsonian Disorders</mesh_term>
    <mesh_term>Genetic Diseases, X-Linked</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 25, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/58/NCT03019458/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 11, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/58/NCT03019458/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>MINGO</title>
          <description>MINGO is a supplement consisting of local ingredients such as moringa, rice and mung beans, which can be added to any type of edible paste, food, and liquid. The experimental group is required to take 6 sachets per day for 12 weeks in addition to their regular diet. They are required to keep a daily food diary&#xD;
MINGO: 6 20oz sachets will be taken daily by intervention group.&#xD;
There were 24 subjects who were part of the MINGO arm.</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>The control group is required to eat their normal diet. They are also required to keep a daily food diary. There were a total of 26 subjects who were enrolled in the Control group</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>MINGO</title>
          <description>MINGO is a supplement consisting of local ingredients such as moringa, rice and mung beans, which can be added to any type of edible paste, food, and liquid. The experimental group is required to take 6 sachets per day for 12 weeks in addition to their regular diet. They are required to keep a daily food diary&#xD;
MINGO: 6 20oz sachets will be taken daily by intervention group</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>The control group is required to eat their normal diet. They are also required to keep a daily food diary.</description>
        </group>
        <group group_id="B3">
          <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="24"/>
            <count group_id="B2" value="26"/>
            <count group_id="B3" value="50"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.2" spread="1.6"/>
                    <measurement group_id="B2" value="56.4" spread="1.6"/>
                    <measurement group_id="B3" value="55.4" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Philippines</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of Illness</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.4" spread="1.1"/>
                    <measurement group_id="B2" value="8.2" spread="1.1"/>
                    <measurement group_id="B3" value="8.8" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18.9" spread="0.6"/>
                    <measurement group_id="B2" value="18.2" spread="0.4"/>
                    <measurement group_id="B3" value="18.5" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mean Upper Arm Circumference (MUAC)</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.5" spread="0.5"/>
                    <measurement group_id="B2" value="26.5" spread="0.6"/>
                    <measurement group_id="B3" value="26.5" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Burkes-Fahn-Marsden (BFM)</title>
          <description>This is a scale that is done to score dystonia severity from 0 to 120 with higher numbers indicating worse outcome. A movement disorder specialist was the one who performed the scale.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44.1" spread="5.3"/>
                    <measurement group_id="B2" value="40.2" spread="4.8"/>
                    <measurement group_id="B3" value="42.1" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Eating Assessment Tool (EAT-10)</title>
          <description>EAT-10 is a subjective swallowing screening tool for dysphagia that ranges from 0-40 with higher scores meaning more difficulty in swallowing</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20.0" spread="2.3"/>
                    <measurement group_id="B2" value="19.9" spread="2.6"/>
                    <measurement group_id="B3" value="19.9" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>MGH-Swallowing Screening Tool (MGH-SST)</title>
          <description>MGH SST is an objective swallowing screening tool to determine the risk of aspiration from 0-5 with 5 being the highest risk to aspiration</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.8" spread="0.3"/>
                    <measurement group_id="B2" value="3.8" spread="0.3"/>
                    <measurement group_id="B3" value="3.8" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Body Mass Index (BMI in kg/m^2) Using a Bathroom Weighing Scale.</title>
        <description>The investigators will first take a baseline Body Mass Index in kg/m^2 for both control and intervention group, then subsequent measures every two weeks for 3 month duration of he trial. The goal of the investigators is to compare the net change in Body Mass Index in a 3 month period.</description>
        <time_frame>after baseline Body Mass Index, we will measure Body Mass Index every 2 weeks for 3 months</time_frame>
        <population>We proposed an intention to treat analysis, so regardless of whether an XDP subject took the prescribed # of MINGO packets or not we analyzed everyone who entered the trial</population>
        <group_list>
          <group group_id="O1">
            <title>MINGO</title>
            <description>MINGO is a supplement consisting of local ingredients such as moringa, rice and mung beans, which can be added to any type of edible paste, food, and liquid. The experimental group is required to take 6 sachets per day for 12 weeks in addition to their regular diet. They are required to keep a daily food diary&#xD;
MINGO: 6 20oz sachets will be taken daily by intervention group.&#xD;
There were 24 subjects who were part of the MINGO arm.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The control group is required to eat their normal diet. They are also required to keep a daily food diary. There were a total of 26 subjects who were enrolled in the Control group</description>
          </group>
        </group_list>
        <measure>
          <title>The Body Mass Index (BMI in kg/m^2) Using a Bathroom Weighing Scale.</title>
          <description>The investigators will first take a baseline Body Mass Index in kg/m^2 for both control and intervention group, then subsequent measures every two weeks for 3 month duration of he trial. The goal of the investigators is to compare the net change in Body Mass Index in a 3 month period.</description>
          <population>We proposed an intention to treat analysis, so regardless of whether an XDP subject took the prescribed # of MINGO packets or not we analyzed everyone who entered the trial</population>
          <units>Kg/m^2</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.86" lower_limit="17.66" upper_limit="20.06"/>
                    <measurement group_id="O2" value="18.17" lower_limit="17.24" upper_limit="19.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.00" lower_limit="17.75" upper_limit="20.24"/>
                    <measurement group_id="O2" value="18.31" lower_limit="17.30" upper_limit="19.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.14" lower_limit="17.91" upper_limit="20.37"/>
                    <measurement group_id="O2" value="18.27" lower_limit="17.25" upper_limit="19.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.11" lower_limit="17.90" upper_limit="20.33"/>
                    <measurement group_id="O2" value="18.06" lower_limit="17.01" upper_limit="19.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.15" lower_limit="17.89" upper_limit="20.40"/>
                    <measurement group_id="O2" value="18.24" lower_limit="17.24" upper_limit="19.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.03" lower_limit="17.77" upper_limit="20.28"/>
                    <measurement group_id="O2" value="18.05" lower_limit="17.01" upper_limit="19.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.07" lower_limit="17.83" upper_limit="20.31"/>
                    <measurement group_id="O2" value="17.95" lower_limit="16.90" upper_limit="18.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.084</p_value>
            <p_value_desc>The p value was not adjusted for multiple comparisons but rather it is the priori threshold for statistical significance at p&lt;0.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>We adjusted for baseline Eating Assessment Tool-10 (EAT-10), MGH-Swallowing Screening Test (MGH-SST), and the Burkes-Fahn-Marsden Dysonia Scale (BFM).</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>All Cause Mortality</title>
        <description>number of deaths in both arms at the end of the study</description>
        <time_frame>3 months (study close out)</time_frame>
        <population>Everyone who enrolled were analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>MINGO</title>
            <description>MINGO is a supplement consisting of local ingredients such as moringa, rice and mung beans, which can be added to any type of edible paste, food, and liquid. The experimental group is required to take 6 sachets per day for 12 weeks in addition to their regular diet. They are required to keep a daily food diary&#xD;
MINGO: 6 20oz sachets will be taken daily by intervention group.&#xD;
There were 24 subjects who were part of the MINGO arm.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The control group is required to eat their normal diet. They are also required to keep a daily food diary. There were a total of 26 subjects who were enrolled in the Control group</description>
          </group>
        </group_list>
        <measure>
          <title>All Cause Mortality</title>
          <description>number of deaths in both arms at the end of the study</description>
          <population>Everyone who enrolled were analyzed</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Hospitalizations Secondary to Infectious Causes</title>
        <description>number of hospitalizations secondary to infections in both arms at the end of the study</description>
        <time_frame>3 months (study close out)</time_frame>
        <population>all participants were analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>MINGO</title>
            <description>MINGO is a supplement consisting of local ingredients such as moringa, rice and mung beans, which can be added to any type of edible paste, food, and liquid. The experimental group is required to take 6 sachets per day for 12 weeks in addition to their regular diet. They are required to keep a daily food diary&#xD;
MINGO: 6 20oz sachets will be taken daily by intervention group</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The control group is required to eat their normal diet. They are also required to keep a daily food diary.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Hospitalizations Secondary to Infectious Causes</title>
          <description>number of hospitalizations secondary to infections in both arms at the end of the study</description>
          <population>all participants were analyzed</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mid Upper Arm Circumference (MUAC) in cm Using a Tailor's Tape Measure</title>
        <description>It has been reported that the Mid Upper Arm Circumference is a good predictor for BMI. It will serve as an indirect measurement to the subjects' BMI</description>
        <time_frame>After baseline measurements, the investigators will measure the MUAC evey month for 3 months</time_frame>
        <population>All participants in the trial</population>
        <group_list>
          <group group_id="O1">
            <title>MINGO</title>
            <description>MINGO is a supplement consisting of local ingredients such as moringa, rice and mung beans, which can be added to any type of edible paste, food, and liquid. The experimental group is required to take 6 sachets per day for 12 weeks in addition to their regular diet. They are required to keep a daily food diary&#xD;
MINGO: 6 20oz sachets will be taken daily by intervention group</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The control group is required to eat their normal diet. They are also required to keep a daily food diary.</description>
          </group>
        </group_list>
        <measure>
          <title>Mid Upper Arm Circumference (MUAC) in cm Using a Tailor's Tape Measure</title>
          <description>It has been reported that the Mid Upper Arm Circumference is a good predictor for BMI. It will serve as an indirect measurement to the subjects' BMI</description>
          <population>All participants in the trial</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.54" lower_limit="25.39" upper_limit="27.59"/>
                    <measurement group_id="O2" value="26.54" lower_limit="25.24" upper_limit="27.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>month 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.93" lower_limit="25.86" upper_limit="28.00"/>
                    <measurement group_id="O2" value="26.58" lower_limit="25.23" upper_limit="27.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>month 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.96" lower_limit="25.85" upper_limit="28.07"/>
                    <measurement group_id="O2" value="26.69" lower_limit="25.13" upper_limit="28.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.69" lower_limit="25.41" upper_limit="27.97"/>
                    <measurement group_id="O2" value="26.62" lower_limit="25.03" upper_limit="28.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>MINGO</title>
          <description>MINGO is a supplement consisting of local ingredients such as moringa, rice and mung beans, which can be added to any type of edible paste, food, and liquid. The experimental group is required to take 6 sachets per day for 12 weeks in addition to their regular diet. They are required to keep a daily food diary&#xD;
MINGO: 6 20oz sachets will be taken daily by intervention group</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>The control group is required to eat their normal diet. They are also required to keep a daily food diary.</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="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Intolerance to taking MINGO</sub_title>
                <description>Any intolerance to taking MINGO that caused the subject to stop taking the supplement including 1 due to vomiting, 1 due to the subjective sensation to fullness, and 2 due to the fact they did not like the taste of MINGO.</description>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="24"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>GI symptoms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </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>
    <limitations_and_caveats>A major limitation to this trial is that it was a community-based clinical trial that relied on 14 CHWs to measure the weight and MUAC due to the far distance and difficult terrain. The accuracy of subject's food diary is a limitation.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Patrick Acuna</name_or_title>
      <organization>Sunshine Care Foundation</organization>
      <phone>+63 947 959-1851</phone>
      <email>patrick_acuna@hotmail.com</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/NCT03019458
org study id: MINGO-001
nct id: NCT03019458
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To see whether MINGO, a food supplement, will be able to lessen the drastic weight loss seen
      among X-linked Dystonia Parkinsonism patients.
X-linked dystonia parkinsonism (XDP, formerly known as DYT3) occurs primarily in Filipino
      males and is characterized by neurodegenerative dystonia and parkinsonism. It is currently
      recognized to have wide phenotypic variability relating to age of onset, location of disease
      onset and rate of severity/disease progression. Most patients begin with focal dystonia that
      generalizes with the development of parkinsonism later in disease course. XDP patients suffer
      from severe nutritional loss due to symptoms such as dysphagia, loss of appetite, and
      consistently high metabolic requirements brought about by their movement disorder.
      Approximately 79% of patients with XDP have experienced rapid weight loss since the onset of
      their disease. It is the aim of the researchers to assess the clinical usefulness of adding a
      nutritional supplement to the daily dietary needs of these patients.

      MINGO is a supplement consisting of local ingredients such as moringa, rice and mung beans,
      which can be added to any type of edible paste, food, and liquid. Mingo has gained popularity
      as an emergency food in disaster relief operations due to the ease of its preparation, its
      high nutritional value and relatively low price. For the last two years, it has also been
      used as an agent for nutritional build up in malnourished populations of children. This study
      will provide valuable information on whether patients with XDP can increase their weight by
      consuming MINGO, which will lead to improvements in the patients' medical care and wellbeing.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: The Body Mass Index (BMI in kg/m^2) Using a Bathroom Weighing Scale.
time frame: after baseline Body Mass Index, we will measure Body Mass Index every 2 weeks for 3 months
description: The investigators will first take a baseline Body Mass Index in kg/m^2 for both control and intervention group, then subsequent measures every two weeks for 3 month duration of he trial. The goal of the investigators is to compare the net change in Body Mass Index in a 3 month period.
measure: All Cause Mortality
time frame: 3 months (study close out)
description: number of deaths in both arms at the end of the study
measure: Number of Hospitalizations Secondary to Infectious Causes
time frame: 3 months (study close out)
description: number of hospitalizations secondary to infections in both arms at the end of the study
measure: Mid Upper Arm Circumference (MUAC) in cm Using a Tailor's Tape Measure
time frame: After baseline measurements, the investigators will measure the MUAC evey month for 3 months
description: It has been reported that the Mid Upper Arm Circumference is a good predictor for BMI. It will serve as an indirect measurement to the subjects' BMI
arm group label: MINGO
arm group type: Experimental
description: MINGO is a supplement consisting of local ingredients such as moringa, rice and mung beans, which can be added to any type of edible paste, food, and liquid. The experimental group is required to take 6 sachets per day for 12 weeks in addition to their regular diet. They are required to keep a daily food diary
arm group label: Control
arm group type: No Intervention
description: The control group is required to eat their normal diet. They are also required to keep a daily food diary.
intervention type: Dietary Supplement
intervention name: MINGO
description: 6 20oz sachets will be taken daily by intervention group
arm group label: MINGO
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Criscely L Go, MD,FPNA,DPBP
role: Principal Investigator
affiliation: Jose R. Reyes Memorial Medical Center
facility: 
country: Philippines
responsible party type: Sponsor
mesh term: Dystonia
mesh term: Dystonic Disorders
mesh term: Parkinsonian Disorders
mesh term: Genetic Diseases, X-Linked
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: A major limitation to this trial is that it was a community-based clinical trial that relied on 14 CHWs to measure the weight and MUAC due to the far distance and difficult terrain. The accuracy of subject's food diary is a limitation.
point of contact: 