<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/NCT02227602</url>
  </required_header>
  <id_info>
    <org_study_id>TexasAMU-IRB2013-0541F</org_study_id>
    <nct_id>NCT02227602</nct_id>
  </id_info>
  <brief_title>Anti-Inflammatory Effects of Mango Polyphenolics in Inflammatory Bowel Disease</brief_title>
  <official_title>The Mango Consumption Improves Biomarkers for Inflammation in Inflammatory Bowel Disease Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Texas A&amp;M University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Texas A&amp;M University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Bioactive compounds from mango are bioavailable and their anti-inflammatory efficacy has been&#xD;
      demonstrated in animals and humans. However, the efficacy of mangoes has not previously been&#xD;
      compared with respect to mild inflammatory bowel disease. In order to justify future&#xD;
      pharmacokinetic and pharmacodynamic analyses in human clinical trials, a pilot assessment to&#xD;
      determine efficacy in preventing or resolving Inflammatory bowel disease is a necessary step.&#xD;
      Therefore, in this aim we will determine the clinical relevance of mango as an adjuvant&#xD;
      treatment to conventional therapy in Inflammatory bowel disease . The effects of mango with&#xD;
      common drug treatment in mild-moderate Inflammatory bowel disease will be compared to the&#xD;
      drug-treatment alone. If mango or any other polyphenolic-rich food could be identified as&#xD;
      helpful in shortening or reducing severity of episodes of inflammatory bowel disease, the&#xD;
      addition of polyphenolics to conventional drug treatment in Inflammatory bowel disease would&#xD;
      have a significant impact on public health.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale and Significance : Bioactive compounds from mango are bioavailable and their&#xD;
      anti-inflammatory efficacy has been demonstrated in animals and humans. However, the efficacy&#xD;
      of mangoes has not previously been compared with respect to mild inflammatory bowel disease.&#xD;
      In order to justify future pharmacokinetic and pharmacodynamic analyses in human clinical&#xD;
      trials, a pilot assessment to determine efficacy in preventing or resolving IBD is a&#xD;
      necessary step. Therefore, in this aim we will determine the clinical relevance of mango as&#xD;
      an adjuvant treatment to conventional therapy in IBD. The effects of mango with common drug&#xD;
      treatment in mild-moderate IBD will be compared to the drug-treatment alone. If mango or any&#xD;
      other polyphenolic-rich food could be identified as helpful in shortening or reducing&#xD;
      severity of episodes of inflammatory bowel disease, the addition of polyphenolics to&#xD;
      conventional drug treatment in IBD would have a significant impact on public health.&#xD;
&#xD;
      The clinical study will be designed in subjects with mild-moderate active Crohn's disease&#xD;
      (CD) or mild to moderate ulcerative colitis (UC). This study will be carried out with up to 8&#xD;
      weeks of mango treatment. Subjects with inflammatory bowel disease (IBD; CD or UC) will be&#xD;
      performed at the Ertan Digestive Disease Center, Houston, TX, or Texas A&amp;M University,&#xD;
      College Station, TX. Patients may be recruited by advertisement (letters, emails, flyers,&#xD;
      newspapers) or during standard of clinical care clinics: a) patients coming in for their&#xD;
      regular, e.g. semi-annual or annual routine colonoscopy, b) UC or CD-related pain or&#xD;
      symptoms, c) individuals presenting with diarrhoea that may be due to Crohn's disease or UC&#xD;
      may also be recruited. Informed written consent will be obtained by the research personnel&#xD;
      before the study begins. Approximately 90 individuals are expected to enroll in the study in&#xD;
      order to obtain 60 subjects completing this study (considering screening failure and&#xD;
      potential drop-outs). We expect a maximum of 90 subjects for the initial screening since many&#xD;
      of these will be preselected from existing patient files.&#xD;
&#xD;
      This study is designed to incorporate standard of care routine exams as performed within the&#xD;
      division of gastroenterology. During the initial screening, the inclusion criteria of&#xD;
      patients will be assessed using the clinical indices. it will be performed a screening in&#xD;
      which above listed inclusion criteria and hemoglobin, and exclusion parameters and height,&#xD;
      weight, calculation of BMI in kg/ (height in meters)2, albumin and C-reactive protein will be&#xD;
      assessed due to the high correlation to IBD-activity (&gt;45 mg/L). Subjects will be asked to&#xD;
      give a stool sample that has to take place within 1 week before any endoscopic procedure is&#xD;
      scheduled and laxatives are taken by the patients in preparation for the procedure.&#xD;
&#xD;
      Study Treatments: Standard of clinical care + 200-400g of Mango b.i.d - t.i.d.,frozen or as&#xD;
      smoothie.&#xD;
&#xD;
      This study will be carried out as a pilot study with up to 8 weeks of mango treatment in&#xD;
      addition to a list of standard of clinical care drugs. Subjects will be asked to record the&#xD;
      exact amount consumed each day. Subjects who skip less than 1 day of mango consumption per&#xD;
      week or less than 8 days over the entire period of 8 weeks of mango consumption will not be&#xD;
      excluded from this study. Subjects will consume their regular diet but reduce the intake of&#xD;
      plant-based dietary supplements which contain secondary plant compounds such as resveratrol,&#xD;
      quercetin, tannins, and also reduce their carbohydrate-derived energy by the same amount&#xD;
      which is supplied through their mango consumption. Patients that are not receiving the mango&#xD;
      will consume their regular diet, which will be controlled for basic nutrients contained in&#xD;
      the mango treatment. The mango treatment will start either on this first study day, or as&#xD;
      soon as subjects can be classified within the inclusion criteria.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">March 2018</completion_date>
  <primary_completion_date type="Actual">May 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Simple Clinical Colitis Activity Index (SCCAI)</measure>
    <time_frame>8 weeks</time_frame>
    <description>A questionnaire used to assess the severity of symptoms in people who suffer from ulcerative colitis&#xD;
The score ranges from 0 to 19, where active disease is a score of 5 or higher&#xD;
compare changes in the score during the study</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Short Inflammatory Bowel Disease Questionnaire (SIBDQ)</measure>
    <time_frame>8 weeks</time_frame>
    <description>A health-related quality of life (HRQoL) tool measuring physical, social, and emotional status&#xD;
All scores were reported with a 7-point scale (Score 1-7, 1 = poor HRQOL, 7 = optimum HRQOL).&#xD;
compare changes in the score during the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomarkers for inflammation : hs-CRP, Nf-kB, Il-6, Il-1b in Plasma (pg/ml)</measure>
    <time_frame>8 weeks</time_frame>
    <description>- compare changes in the levels during the study</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Intestinal Diseases</condition>
  <condition>Ulcerative Colitis</condition>
  <condition>Crohn Disease</condition>
  <arm_group>
    <arm_group_label>Mango</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mango polyphenolics</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mango polyphenolics</intervention_name>
    <description>Frozen mango pack will be provided (200~400g per day).</description>
    <arm_group_label>Mango</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female ages 18-79 years (see Protection of Human Subjects)&#xD;
&#xD;
          -  Treated with mesalamine or any mesalamine derivate, e.g.Asacol, Apriso, Asacol,&#xD;
             Canasa, Lialda, Pentasa, Rowasa orally or rectally as standard of clinical care in the&#xD;
             treatment of their symptoms for Inflammatory bowel disease&#xD;
&#xD;
          -  Treated using biologic immune-modulators including but not limited to: Infliximab,&#xD;
             Adalimumab, Certolizumab, Natalizumab, azathioprine.&#xD;
&#xD;
          -  Additionally, patients may be on steroids (prednisone 10mg, budesonide 9mg)&#xD;
&#xD;
          -  Subjects must have been on a stable drug-regiment for at least 3 weeks before study&#xD;
             begin.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of acute cardiac event, stroke, or cancer, within the last 6 months,&#xD;
&#xD;
          -  recurrent hospitalizations,&#xD;
&#xD;
          -  drug treatment of any of the listed conditions within the last 6 months,&#xD;
&#xD;
          -  abuse of alcohol or substance within the last 6 months,&#xD;
&#xD;
          -  currently smoking more than 1 pack/week,&#xD;
&#xD;
          -  seizures,&#xD;
&#xD;
          -  liver or renal dysfunction,&#xD;
&#xD;
          -  pregnancy or lactation,&#xD;
&#xD;
          -  allergy against mangos,&#xD;
&#xD;
          -  hepatitis B, C, or HIV,&#xD;
&#xD;
          -  regular exercise (&gt;60 minutes, ≥ 5 times/wk), due to association of antioxidant and&#xD;
             anti-inflammatory effects and moderate exercise.&#xD;
&#xD;
          -  known lactose intolerance, gluten sensitivity, or celiac disease&#xD;
&#xD;
          -  Patients that have upcoming Inflammatory bowel disease-related surgery and&#xD;
             Inflammatory bowel disease -related intestinal stricture will also be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>72 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susanne Talcott, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Texas A&amp;M University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Texas A&amp;M University, Clinical Lab, Nutrition and Food Science Department</name>
      <address>
        <city>College Station</city>
        <state>Texas</state>
        <zip>77843</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>June 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <last_update_submitted>December 2, 2019</last_update_submitted>
  <last_update_submitted_qc>December 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Texas A&amp;M University</investigator_affiliation>
    <investigator_full_name>Susanne Talcott, PhD</investigator_full_name>
    <investigator_title>Associate Professor, Nutition &amp; Food Science</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</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/NCT02227602
org study id: TexasAMU-IRB2013-0541F
nct id: NCT02227602
lead sponsor: 
has dmc: Yes
Bioactive compounds from mango are bioavailable and their anti-inflammatory efficacy has been
      demonstrated in animals and humans. However, the efficacy of mangoes has not previously been
      compared with respect to mild inflammatory bowel disease. In order to justify future
      pharmacokinetic and pharmacodynamic analyses in human clinical trials, a pilot assessment to
      determine efficacy in preventing or resolving Inflammatory bowel disease is a necessary step.
      Therefore, in this aim we will determine the clinical relevance of mango as an adjuvant
      treatment to conventional therapy in Inflammatory bowel disease . The effects of mango with
      common drug treatment in mild-moderate Inflammatory bowel disease will be compared to the
      drug-treatment alone. If mango or any other polyphenolic-rich food could be identified as
      helpful in shortening or reducing severity of episodes of inflammatory bowel disease, the
      addition of polyphenolics to conventional drug treatment in Inflammatory bowel disease would
      have a significant impact on public health.
Rationale and Significance : Bioactive compounds from mango are bioavailable and their
      anti-inflammatory efficacy has been demonstrated in animals and humans. However, the efficacy
      of mangoes has not previously been compared with respect to mild inflammatory bowel disease.
      In order to justify future pharmacokinetic and pharmacodynamic analyses in human clinical
      trials, a pilot assessment to determine efficacy in preventing or resolving IBD is a
      necessary step. Therefore, in this aim we will determine the clinical relevance of mango as
      an adjuvant treatment to conventional therapy in IBD. The effects of mango with common drug
      treatment in mild-moderate IBD will be compared to the drug-treatment alone. If mango or any
      other polyphenolic-rich food could be identified as helpful in shortening or reducing
      severity of episodes of inflammatory bowel disease, the addition of polyphenolics to
      conventional drug treatment in IBD would have a significant impact on public health.

      The clinical study will be designed in subjects with mild-moderate active Crohn's disease
      (CD) or mild to moderate ulcerative colitis (UC). This study will be carried out with up to 8
      weeks of mango treatment. Subjects with inflammatory bowel disease (IBD; CD or UC) will be
      performed at the Ertan Digestive Disease Center, Houston, TX, or Texas A&M University,
      College Station, TX. Patients may be recruited by advertisement (letters, emails, flyers,
      newspapers) or during standard of clinical care clinics: a) patients coming in for their
      regular, e.g. semi-annual or annual routine colonoscopy, b) UC or CD-related pain or
      symptoms, c) individuals presenting with diarrhoea that may be due to Crohn's disease or UC
      may also be recruited. Informed written consent will be obtained by the research personnel
      before the study begins. Approximately 90 individuals are expected to enroll in the study in
      order to obtain 60 subjects completing this study (considering screening failure and
      potential drop-outs). We expect a maximum of 90 subjects for the initial screening since many
      of these will be preselected from existing patient files.

      This study is designed to incorporate standard of care routine exams as performed within the
      division of gastroenterology. During the initial screening, the inclusion criteria of
      patients will be assessed using the clinical indices. it will be performed a screening in
      which above listed inclusion criteria and hemoglobin, and exclusion parameters and height,
      weight, calculation of BMI in kg/ (height in meters)2, albumin and C-reactive protein will be
      assessed due to the high correlation to IBD-activity (>45 mg/L). Subjects will be asked to
      give a stool sample that has to take place within 1 week before any endoscopic procedure is
      scheduled and laxatives are taken by the patients in preparation for the procedure.

      Study Treatments: Standard of clinical care + 200-400g of Mango b.i.d - t.i.d.,frozen or as
      smoothie.

      This study will be carried out as a pilot study with up to 8 weeks of mango treatment in
      addition to a list of standard of clinical care drugs. Subjects will be asked to record the
      exact amount consumed each day. Subjects who skip less than 1 day of mango consumption per
      week or less than 8 days over the entire period of 8 weeks of mango consumption will not be
      excluded from this study. Subjects will consume their regular diet but reduce the intake of
      plant-based dietary supplements which contain secondary plant compounds such as resveratrol,
      quercetin, tannins, and also reduce their carbohydrate-derived energy by the same amount
      which is supplied through their mango consumption. Patients that are not receiving the mango
      will consume their regular diet, which will be controlled for basic nutrients contained in
      the mango treatment. The mango treatment will start either on this first study day, or as
      soon as subjects can be classified within the inclusion criteria.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Simple Clinical Colitis Activity Index (SCCAI)
time frame: 8 weeks
description: A questionnaire used to assess the severity of symptoms in people who suffer from ulcerative colitis
The score ranges from 0 to 19, where active disease is a score of 5 or higher
compare changes in the score during the study
measure: Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
time frame: 8 weeks
description: A health-related quality of life (HRQoL) tool measuring physical, social, and emotional status
All scores were reported with a 7-point scale (Score 1-7, 1 = poor HRQOL, 7 = optimum HRQOL).
compare changes in the score during the study
measure: Biomarkers for inflammation : hs-CRP, Nf-kB, Il-6, Il-1b in Plasma (pg/ml)
time frame: 8 weeks
description: - compare changes in the levels during the study
arm group label: Mango
arm group type: Experimental
description: Mango polyphenolics
intervention type: Drug
intervention name: Mango polyphenolics
description: Frozen mango pack will be provided (200~400g per day).
arm group label: Mango
criteria: 
gender: All
minimum age: 18 Years
maximum age: 72 Years
healthy volunteers: No
last name: Susanne Talcott, Ph.D
role: Principal Investigator
affiliation: Texas A&M University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Texas A&M University
investigator full name: Susanne Talcott, PhD
investigator title: Associate Professor, Nutition & Food Science
mesh term: Crohn Disease
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases