<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/NCT01699009</url>
  </required_header>
  <id_info>
    <org_study_id>WCCR-MIG2</org_study_id>
    <nct_id>NCT01699009</nct_id>
  </id_info>
  <brief_title>A Nutritional Intervention for Migraines-2</brief_title>
  <acronym>WCCR-MIG2</acronym>
  <official_title>A Nutritional Intervention for Migraines-2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Physicians Committee for Responsible Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Physicians Committee for Responsible Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to assess whether, in individuals with migraines, a low-fat,&#xD;
      vegan diet improves pain more effectively than a control supplement or a placebo. The&#xD;
      principal measures are pain as measured by Visual Analog Scale (VAS) and the change in&#xD;
      migraines frequency. The study duration is 36 weeks.This study also tests that a low fat,&#xD;
      plant-based (vegan) diet free of foods commonly identified as triggers improves mood, using&#xD;
      the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R), and the Beck&#xD;
      Depression Inventory II (BDI-II).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Preliminary evidence suggests that low-fat, vegetarian diets and certain nutritional&#xD;
      supplements can help reduce pain and also reduce the need for pain medications for some&#xD;
      people. The investigators will ask about 100 people to participate. All of them will get a&#xD;
      low-fat, vegan diet and a nutritional supplement (mixture of omega-3 oils and vitamin E or a&#xD;
      placebo), although some will get the diet first, and others will get the supplement first.&#xD;
      This order in which they will get the diet and the supplement will be determined randomly,&#xD;
      that is, by chance (like the toss of a coin). The principal measures are pain as measured by&#xD;
      Visual Analog Scale (VAS)and the change in migraines frequency.&#xD;
&#xD;
      Mood change will be measured using the Center for Epidemiologic Studies Depression&#xD;
      Scale-Revised (CESD-R), and the Beck Depression Inventory II (BDI-II).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Migraines Pain Change in Migraines frequency</measure>
    <time_frame>Baseline and 4 months</time_frame>
    <description>Pain as measured by VAS score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Migraines frequency</measure>
    <time_frame>Baseline and 4 months</time_frame>
    <description>the reduction in the number of migraine attacks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Improvement in Mood</measure>
    <time_frame>Baseline and 4 months</time_frame>
    <description>mood changes will be measured using the Beck Depression Inventory II (BDI-II).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Improvement in Mood</measure>
    <time_frame>Baseline and 4 months</time_frame>
    <description>Mood changes will be measured using the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>Baseline and 4 months</time_frame>
    <description>Health related quality of life as measured by a questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Migraines</condition>
  <arm_group>
    <arm_group_label>Vegan diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The diet group will be asked to follow a low-fat, vegan diet for 16 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Supplement group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The supplement group will follow an unrestricted diet, but will be given a pill containing a small, clinically insignificant amount of omega- 3 oils and vitamin E, which will serve as a placebo.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Plant based diet</intervention_name>
    <arm_group_label>Vegan diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>an unrestricted diet</intervention_name>
    <arm_group_label>Supplement group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        A diagnosis of migraine, as defined by the criteria of the second edition of the&#xD;
        International Classification of Headache Disorders:&#xD;
&#xD;
        At least 5 attacks fulfilling criteria the criteria below:&#xD;
&#xD;
          -  Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)&#xD;
&#xD;
          -  Headache has at least two of the following characteristics:&#xD;
&#xD;
          -  unilateral location&#xD;
&#xD;
          -  pulsating quality&#xD;
&#xD;
          -  moderate or severe pain intensity&#xD;
&#xD;
          -  aggravation by or causing avoidance of routine physical activity (eg, walking or&#xD;
             climbing stairs)&#xD;
&#xD;
          -  During headache at least one of the following:&#xD;
&#xD;
          -  nausea and/or vomiting&#xD;
&#xD;
          -  photophobia and phonophobia Not attributed to another disorder&#xD;
&#xD;
          -  Migraines occurring at least twice per month, on average.&#xD;
&#xD;
          -  Age at least 18 years&#xD;
&#xD;
          -  Ability and willingness to participate in all components of the study&#xD;
&#xD;
          -  Willingness to be assigned to either the diet group or supplement group&#xD;
&#xD;
          -  Migraine medications unchanged within last 6 weeks.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt; 18 years of age&#xD;
&#xD;
          -  Alcohol consumption of more than 2 drinks per day or the equivalent, episodic&#xD;
             increased drinking (e.g., more than 2 drinks per day on weekends), or a history of&#xD;
             alcohol abuse or dependency followed by any current use&#xD;
&#xD;
          -  Use of recreational drugs in the past 6 months (past drug use, if fully recovered, is&#xD;
             not a criteria for exclusion)&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Unstable medical or psychiatric illness&#xD;
&#xD;
          -  Likely to be disruptive in group sessions (as determined by research staff)&#xD;
&#xD;
          -  Already following a low-fat, vegan diet&#xD;
&#xD;
          -  Lack of English fluency&#xD;
&#xD;
          -  Inability to maintain current medication regimen&#xD;
&#xD;
          -  Inability or unwillingness to participate in all components of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Neal Barnard, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Physicians Committee for Responsible Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Physicians Committee for Responsible Medicine</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>October 19, 2015</last_update_submitted>
  <last_update_submitted_qc>October 19, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Migraines, diet, vegan, vegetarian, plant-based</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01699009
org study id: WCCR-MIG2
nct id: NCT01699009
lead sponsor: 
has dmc: Yes
The purpose of the study is to assess whether, in individuals with migraines, a low-fat,
      vegan diet improves pain more effectively than a control supplement or a placebo. The
      principal measures are pain as measured by Visual Analog Scale (VAS) and the change in
      migraines frequency. The study duration is 36 weeks.This study also tests that a low fat,
      plant-based (vegan) diet free of foods commonly identified as triggers improves mood, using
      the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R), and the Beck
      Depression Inventory II (BDI-II).
Preliminary evidence suggests that low-fat, vegetarian diets and certain nutritional
      supplements can help reduce pain and also reduce the need for pain medications for some
      people. The investigators will ask about 100 people to participate. All of them will get a
      low-fat, vegan diet and a nutritional supplement (mixture of omega-3 oils and vitamin E or a
      placebo), although some will get the diet first, and others will get the supplement first.
      This order in which they will get the diet and the supplement will be determined randomly,
      that is, by chance (like the toss of a coin). The principal measures are pain as measured by
      Visual Analog Scale (VAS)and the change in migraines frequency.

      Mood change will be measured using the Center for Epidemiologic Studies Depression
      Scale-Revised (CESD-R), and the Beck Depression Inventory II (BDI-II).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Migraines Pain Change in Migraines frequency
time frame: Baseline and 4 months
description: Pain as measured by VAS score
measure: Change in Migraines frequency
time frame: Baseline and 4 months
description: the reduction in the number of migraine attacks.
measure: Improvement in Mood
time frame: Baseline and 4 months
description: mood changes will be measured using the Beck Depression Inventory II (BDI-II).
measure: Improvement in Mood
time frame: Baseline and 4 months
description: Mood changes will be measured using the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R).
measure: Quality of life
time frame: Baseline and 4 months
description: Health related quality of life as measured by a questionnaire
arm group label: Vegan diet
arm group type: Experimental
description: The diet group will be asked to follow a low-fat, vegan diet for 16 weeks.
arm group label: Supplement group
arm group type: Placebo Comparator
description: The supplement group will follow an unrestricted diet, but will be given a pill containing a small, clinically insignificant amount of omega- 3 oils and vitamin E, which will serve as a placebo.
intervention type: Other
intervention name: Plant based diet
arm group label: Vegan diet
intervention type: Other
intervention name: an unrestricted diet
arm group label: Supplement group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Neal Barnard, MD
role: Principal Investigator
affiliation: Physicians Committee for Responsible Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Migraine Disorders