<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/NCT02227615</url>
  </required_header>
  <id_info>
    <org_study_id>TexasAMU-IRB2011-0735F</org_study_id>
    <nct_id>NCT02227615</nct_id>
  </id_info>
  <brief_title>Absorption of Mango in Healthy Individuals</brief_title>
  <official_title>Profile of Metabolites After the Intake of Mango (Mangifera Indica, l.) Var. Keitt in Humans</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>
      The objective of this research is to characterize the urinary metabolites produced after the&#xD;
      consumption of mango pulp in an effort to begin to characterize the bioavailability of the&#xD;
      major group of polyphenolics in mango, ester-linked gallic acids, and to provide new insight&#xD;
      into their in vivo physiological behavior.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eleven healthy volunteers (2 male, 9 female) who had no medical history of digestive&#xD;
      disorders or chronic diseases participated in the 10-day mango consumption study. They were&#xD;
      aged between 21-38 years and with a weight between 45-95 kg. Participants were asked to stop&#xD;
      taking dietary supplements for 1 week prior to the study begin and study duration and asked&#xD;
      to avoid excessive exercise and alcohol consumption 3 days prior to the start of the study&#xD;
      day 1 and study day 10. Participants were also required to fill out a 72-hour nutritional&#xD;
      report at home that detailed their food consumption over the previous 3 days leading up to&#xD;
      the first and tenth day and were reviewed for compliance. All participants fasted from fruit&#xD;
      and vegetables, coffee and tea one day prior to study day 1 and 10 and were asked to bring in&#xD;
      a stool sample collected prior to consumption of mango on the first day of the study. After&#xD;
      an overnight fast of at least 12 hours, urine collections were made (baseline) and a baseline&#xD;
      blood draw was taken from each participant. Each participant was given 400 grams of mango to&#xD;
      consume and urine collections were made at 0-3, 3-6, 6-8, and 8-12 hours. The volume of urine&#xD;
      was recorded and an aliquot immediately frozen at -80°C until analysis. Blood samples were&#xD;
      also taken at 0.5, 1, 2, 3, 4, 6, 8, and 12hrs, collected in heparinized tubes and&#xD;
      centrifuged for 10 mins at 4000 x g, 4°C. Supernatant (plasma) was aliquoted into 2mL&#xD;
      samples, acidified with 50 μL 85% formic acid, and immediately frozen at -80° C until&#xD;
      analysis. Participants were given 400 grams of mango to consume daily for the next eight days&#xD;
      and the study design was repeated again on the 10th day. After completion of the tenth day of&#xD;
      study, stool samples were collected and immediately frozen at -20°C for microbial analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>March 2013</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2016</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>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in the levels of metabolites of gallic acid in urine after mango intake.</measure>
    <time_frame>1 year</time_frame>
    <description>Aliquoted urine samples were thawed and centrifuged at 13,000 x g for 10 mins at 4°C immediately prior to analysis by HPLC-MSn. All quantification of metabolites (pyrogalloyl-O-glucuronide, O-methyl-gallic acid, O-methylgallic acid-O-sulfate, O-methylpyrogalloyl-O-sulfate, pyrogalloyl-O-sulfate, deoxypyrogallol-O-sulfate, O-methylpyrogalloyl-O-sulfate) was performed in full MS and expressed as gallic acid equivalents. To standardize the concentration of metabolites for the sake of comparison across varying weights, heights, and volume of urine collected by each participant; urinary creatinine concentrations were calculated for each sample using a routine Creatinine enzyme assay kit (Sigma-Aldrich). All values are expressed as mg of standard/10 mg creatinine (mg gallic acid equivalent /10mg creatinine).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Absorption; Chemicals</condition>
  <arm_group>
    <arm_group_label>Sugary beverage</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Sugary beverage</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mango beverage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mango polyphenolics</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Mango polyphenolics</intervention_name>
    <description>Frozen Mango (Keitt) packs provided to subjects.</description>
    <arm_group_label>Mango beverage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Sugary beverage</intervention_name>
    <description>15.7g sugar, 3.8g pectin and 0.05g citric acid was added in 100ml of the control beverage.</description>
    <arm_group_label>Sugary beverage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  No medical history of digestive disorders or chronic diseases&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have medical history of digestive disorders or chronic diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</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>Exercise &amp; Sport Nutrition Laboratory (ESNL) in the Department of Health and Kinesiology at Texas A&amp;M University</name>
      <address>
        <city>College station</city>
        <state>Texas</state>
        <zip>77845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2016</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>October 14, 2016</last_update_submitted>
  <last_update_submitted_qc>October 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02227615
org study id: TexasAMU-IRB2011-0735F
nct id: NCT02227615
lead sponsor: 
has dmc: Yes
The objective of this research is to characterize the urinary metabolites produced after the
      consumption of mango pulp in an effort to begin to characterize the bioavailability of the
      major group of polyphenolics in mango, ester-linked gallic acids, and to provide new insight
      into their in vivo physiological behavior.
Eleven healthy volunteers (2 male, 9 female) who had no medical history of digestive
      disorders or chronic diseases participated in the 10-day mango consumption study. They were
      aged between 21-38 years and with a weight between 45-95 kg. Participants were asked to stop
      taking dietary supplements for 1 week prior to the study begin and study duration and asked
      to avoid excessive exercise and alcohol consumption 3 days prior to the start of the study
      day 1 and study day 10. Participants were also required to fill out a 72-hour nutritional
      report at home that detailed their food consumption over the previous 3 days leading up to
      the first and tenth day and were reviewed for compliance. All participants fasted from fruit
      and vegetables, coffee and tea one day prior to study day 1 and 10 and were asked to bring in
      a stool sample collected prior to consumption of mango on the first day of the study. After
      an overnight fast of at least 12 hours, urine collections were made (baseline) and a baseline
      blood draw was taken from each participant. Each participant was given 400 grams of mango to
      consume and urine collections were made at 0-3, 3-6, 6-8, and 8-12 hours. The volume of urine
      was recorded and an aliquot immediately frozen at -80°C until analysis. Blood samples were
      also taken at 0.5, 1, 2, 3, 4, 6, 8, and 12hrs, collected in heparinized tubes and
      centrifuged for 10 mins at 4000 x g, 4°C. Supernatant (plasma) was aliquoted into 2mL
      samples, acidified with 50 μL 85% formic acid, and immediately frozen at -80° C until
      analysis. Participants were given 400 grams of mango to consume daily for the next eight days
      and the study design was repeated again on the 10th day. After completion of the tenth day of
      study, stool samples were collected and immediately frozen at -20°C for microbial analysis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Change from baseline in the levels of metabolites of gallic acid in urine after mango intake.
time frame: 1 year
description: Aliquoted urine samples were thawed and centrifuged at 13,000 x g for 10 mins at 4°C immediately prior to analysis by HPLC-MSn. All quantification of metabolites (pyrogalloyl-O-glucuronide, O-methyl-gallic acid, O-methylgallic acid-O-sulfate, O-methylpyrogalloyl-O-sulfate, pyrogalloyl-O-sulfate, deoxypyrogallol-O-sulfate, O-methylpyrogalloyl-O-sulfate) was performed in full MS and expressed as gallic acid equivalents. To standardize the concentration of metabolites for the sake of comparison across varying weights, heights, and volume of urine collected by each participant; urinary creatinine concentrations were calculated for each sample using a routine Creatinine enzyme assay kit (Sigma-Aldrich). All values are expressed as mg of standard/10 mg creatinine (mg gallic acid equivalent /10mg creatinine).
arm group label: Sugary beverage
arm group type: Placebo Comparator
description: Sugary beverage
arm group label: Mango beverage
arm group type: Experimental
description: Mango polyphenolics
intervention type: Dietary Supplement
intervention name: Mango polyphenolics
description: Frozen Mango (Keitt) packs provided to subjects.
arm group label: Mango beverage
intervention type: Dietary Supplement
intervention name: Sugary beverage
description: 15.7g sugar, 3.8g pectin and 0.05g citric acid was added in 100ml of the control beverage.
arm group label: Sugary beverage
criteria: 
gender: All
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Susanne Talcott, Ph.D.
role: Principal Investigator
affiliation: Texas A&M University
facility: 
country: United States
responsible party type: Sponsor