<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/NCT04431700</url>
  </required_header>
  <id_info>
    <org_study_id>20-001120</org_study_id>
    <nct_id>NCT04431700</nct_id>
  </id_info>
  <brief_title>Study of Dietary Composition in Crohn's Disease</brief_title>
  <acronym>CD</acronym>
  <official_title>Impact of Anti-Inflammatory Whole-Food Diet in Crohn's Disease and Predicting Response to Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Los Angeles</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>
      Patients with inflammatory bowel disease (IBD) often have narrowed microbial diversity and&#xD;
      altered composition and function of the gut microbiome. We anticipate the anti-inflammatory&#xD;
      diet, when compared with the usual diet, to produce favorable changes in these multi-omics&#xD;
      profiles. These findings will provide insight into the interactions between diet and host&#xD;
      biology, while providing clues on the mechanisms of diet therapy's effect and CD&#xD;
      pathogenesis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized controlled trial of the anti-inflammatory whole food diet versus usual diet for&#xD;
      the induction of remission in 104 adults with mild-to-moderate Crohn's Disease (CD). The&#xD;
      anti-inflammatory whole food diet will be compared to participants usual diet for&#xD;
      understanding its effects on achieving clinical remission, clinical response, reduction in&#xD;
      serological and fecal markers of inflammation, and improvement in patient-reported outcomes,&#xD;
      such as physical activity, anxiety, depression, fatigue, pain, sleep disturbance, social&#xD;
      satisfaction, and quality of life. The study will involve collection of blood and fecal&#xD;
      specimens to evaluate the effects of the anti-inflammatory diet on the gut microbiome,&#xD;
      bacterial metabolome, innate immune markers, and fecal microRNA profiles. The participants&#xD;
      will be placed on anti-inflammatory diet for 8 weeks and assessed every 2 weeks for&#xD;
      adherence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 5, 2020</start_date>
  <completion_date type="Anticipated">May 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2025</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>
    <intervention_model_description>This is a randomized, single-blind, controlled trial. All eligible participants will be randomly assigned to one of two diets.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of the anti-inflammatory whole food diet for the induction of remission in Crohn's Disease</measure>
    <time_frame>8 weeks</time_frame>
    <description>The patients' clinical response, defined by the Harvey-Bradshaw Index (HBI) (5 through 16 points) for clinical symptom improvement and/or remission.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">116</enrollment>
  <condition>Inflammatory Bowel Diseases</condition>
  <condition>Crohn Disease</condition>
  <arm_group>
    <arm_group_label>Anti-inflammatory whole food</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Included food items will include a defined minimum diversity of fruits, vegetables, and nuts based on complementary phytonutrient contents, particularly those rich in phenolic compounds such as ellagitannins and sulforaphanes. Selected herbs (e.g., curcumin), fermented foods, fats (e.g., avocado), and oils (e.g., olive oil) will be permitted or encouraged. Recommended portions of complex carbohydrates (50% - 60%) and lean proteins (20% - 30%) will form the basis of weight-based caloric needs. The goal is to have 5 servings of vegetables, 2 fruits per day, and 5 vegetable color groups per week. Vegetables with high insoluble fiber content will be cooked instead of eaten raw.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Regular Diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in the control diet arm will be counseled to continue their regular diets and focus on recording all food intake.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Anti-inflammatory diet</intervention_name>
    <description>Anti-inflammatory diet with increased vegetables, fruit, plant polyphenols, lean proteins, foods rich in omega-3s and unsaturated fats as well as decreased in processed refined foods.</description>
    <arm_group_label>Anti-inflammatory whole food</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Regular diet</intervention_name>
    <description>Focus on food journal and recording all food intake.</description>
    <arm_group_label>Regular Diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age of 18 to 75 years old&#xD;
&#xD;
          -  History of Crohn's Disease (CD) with mild to moderate symptoms and prior biopsy proof&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History or current diagnosis of any of the following:&#xD;
&#xD;
               -  Stroke or Arrhythmia&#xD;
&#xD;
               -  Seizures&#xD;
&#xD;
               -  Liver Disease&#xD;
&#xD;
               -  Untreated hypertension (High Blood Pressure)&#xD;
&#xD;
               -  Active malignancy&#xD;
&#xD;
               -  Bleeding disorders&#xD;
&#xD;
               -  Heart Disease&#xD;
&#xD;
               -  Lung disease&#xD;
&#xD;
               -  Previous Heart surgery&#xD;
&#xD;
               -  Previous Gastrointestinal Surgery&#xD;
&#xD;
               -  Kidney Disease&#xD;
&#xD;
               -  Chronic Diarrhea&#xD;
&#xD;
               -  End enterostomy&#xD;
&#xD;
               -  Bulimia&#xD;
&#xD;
               -  Anorexia&#xD;
&#xD;
               -  Laxative Abuse&#xD;
&#xD;
               -  Endocrine Disorder&#xD;
&#xD;
               -  Current history of smoking tobacco&#xD;
&#xD;
               -  Urgent need for abdominal sugery&#xD;
&#xD;
               -  Severe Malnutrition&#xD;
&#xD;
               -  Active alcohol or non-cannabinoid substance abuse&#xD;
&#xD;
          2. Recent hospitalization within the last 30 days&#xD;
&#xD;
          3. Currently pregnant of lactating.&#xD;
&#xD;
          4. Current use probiotics or dietary supplements that would not be willing to discontinue&#xD;
             for the length of the study.&#xD;
&#xD;
          5. Concerns for non-compliance&#xD;
&#xD;
          6. If currently on immunosuppressants, immunomodulators, cotticosteroids, and/or&#xD;
             5-aminosalicylates, no changes in doses will be permitted during the trial except for&#xD;
             tapering of corticosteroids.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhaoping Li, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gail Thames</last_name>
    <phone>310-825-0453</phone>
    <email>Gthames@mednet.ucla.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dina Ben-Nissan</last_name>
    <phone>310-206-2582</phone>
    <email>Dbennissan@mednet.ucla.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UCLA Center for Human Nutrition, 1000 Veteran Ave.</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gail Thames</last_name>
      <phone>310-825-0453</phone>
      <email>gthames@mednet.ucla.edu</email>
    </contact>
    <contact_backup>
      <last_name>Dina Ben-Nissan</last_name>
      <phone>310-206-2582</phone>
      <email>dbennissan@mednet.ucla.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Zhaoping Li</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>May 4, 2023</last_update_submitted>
  <last_update_submitted_qc>May 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Zhaoping Li</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Crohn's Disease</keyword>
  <keyword>IBD</keyword>
  <keyword>Anti-inflammatory Diet</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Inflammatory Agents</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04431700
org study id: 20-001120
nct id: NCT04431700
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients with inflammatory bowel disease (IBD) often have narrowed microbial diversity and
      altered composition and function of the gut microbiome. We anticipate the anti-inflammatory
      diet, when compared with the usual diet, to produce favorable changes in these multi-omics
      profiles. These findings will provide insight into the interactions between diet and host
      biology, while providing clues on the mechanisms of diet therapy's effect and CD
      pathogenesis.
A randomized controlled trial of the anti-inflammatory whole food diet versus usual diet for
      the induction of remission in 104 adults with mild-to-moderate Crohn's Disease (CD). The
      anti-inflammatory whole food diet will be compared to participants usual diet for
      understanding its effects on achieving clinical remission, clinical response, reduction in
      serological and fecal markers of inflammation, and improvement in patient-reported outcomes,
      such as physical activity, anxiety, depression, fatigue, pain, sleep disturbance, social
      satisfaction, and quality of life. The study will involve collection of blood and fecal
      specimens to evaluate the effects of the anti-inflammatory diet on the gut microbiome,
      bacterial metabolome, innate immune markers, and fecal microRNA profiles. The participants
      will be placed on anti-inflammatory diet for 8 weeks and assessed every 2 weeks for
      adherence.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a randomized, single-blind, controlled trial. All eligible participants will be randomly assigned to one of two diets.
primary purpose: Prevention
masking: None (Open Label)
measure: Efficacy of the anti-inflammatory whole food diet for the induction of remission in Crohn's Disease
time frame: 8 weeks
description: The patients' clinical response, defined by the Harvey-Bradshaw Index (HBI) (5 through 16 points) for clinical symptom improvement and/or remission.
arm group label: Anti-inflammatory whole food
arm group type: Experimental
description: Included food items will include a defined minimum diversity of fruits, vegetables, and nuts based on complementary phytonutrient contents, particularly those rich in phenolic compounds such as ellagitannins and sulforaphanes. Selected herbs (e.g., curcumin), fermented foods, fats (e.g., avocado), and oils (e.g., olive oil) will be permitted or encouraged. Recommended portions of complex carbohydrates (50% - 60%) and lean proteins (20% - 30%) will form the basis of weight-based caloric needs. The goal is to have 5 servings of vegetables, 2 fruits per day, and 5 vegetable color groups per week. Vegetables with high insoluble fiber content will be cooked instead of eaten raw.
arm group label: Regular Diet
arm group type: Active Comparator
description: Patients in the control diet arm will be counseled to continue their regular diets and focus on recording all food intake.
intervention type: Other
intervention name: Anti-inflammatory diet
description: Anti-inflammatory diet with increased vegetables, fruit, plant polyphenols, lean proteins, foods rich in omega-3s and unsaturated fats as well as decreased in processed refined foods.
arm group label: Anti-inflammatory whole food
intervention type: Other
intervention name: Regular diet
description: Focus on food journal and recording all food intake.
arm group label: Regular Diet
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Zhaoping Li, MD, PhD
role: Principal Investigator
affiliation: University of California, Los Angeles
last name: Gail Thames
phone: 310-825-0453
email: Gthames@mednet.ucla.edu
last name: Dina Ben-Nissan
phone: 310-206-2582
email: Dbennissan@mednet.ucla.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Zhaoping Li
investigator title: Principal Investigator
mesh term: Crohn Disease
mesh term: Inflammatory Bowel Diseases
mesh term: Anti-Inflammatory Agents
sharing ipd: No