<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/NCT02245906</url>
  </required_header>
  <id_info>
    <org_study_id>BRASIL-MET</org_study_id>
    <nct_id>NCT02245906</nct_id>
  </id_info>
  <brief_title>Effect of Brazilian Fruits Peel on Metabolic Regulation and Appetite in Healthy Subjects</brief_title>
  <acronym>BRASIL-MET</acronym>
  <official_title>Investigation on Effect of Brazilian Fruits on Glucose and Insulin Responses, Anti-inflammatory Properties, Antioxidative Capacity and Satiety in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lund University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Campinas, Brazil</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Lund University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study was to investigate how Brazilian fruits peel affect&#xD;
      acute/postprandial glucose and insulin responses, inflammatory markers, appetite control&#xD;
      peptides, antioxidative capacity, as well as subjective appetite ratings (VAS-visual analogue&#xD;
      scales) in healthy volunteers. We hypothesize that certain Brazilian fruits peel added to a&#xD;
      standardized meal will improve postprandial glucose tolerance and other metabolic biomarkers&#xD;
      in healthy volunteers, compared with a similar meal without the corresponding plant&#xD;
      materials.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changing on blood glucose concentration after treatment with brazilian fruits peel</measure>
    <time_frame>Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min</time_frame>
    <description>The capillary blood samples will be taken for blood glucose analysis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changing on subjective appetite ratings after treatment with Brazilian fruits peel</measure>
    <time_frame>Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min.</time_frame>
    <description>Appetite will be assessed using standard subjective 100 mm VAS (visual analogue scale) at time intervals throughout each visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identify plasma metabolite profile (untargeted approach) after treatment with Brazilian fruits peel</measure>
    <time_frame>Prior to the initial intervention at 0 min and after intervention at 60, 90, 120, 180 min.</time_frame>
    <description>Metabolite profile will be analyzed using Liquid Chromatography-Mass Spectrometry based methods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changing on insulin after treatment with Brazilian fruits peel</measure>
    <time_frame>Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min.</time_frame>
    <description>The venous serum blood samples will be taken for insulin analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changing on inflammatory markers (i.e. interleukin-6, interleukin-8, tumor necrosis factor-alpha, necrosis factor kappa-beta, adiponectin and C-reactive protein) after treatment with Brazilian fruits peel</measure>
    <time_frame>Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min.</time_frame>
    <description>The venous serum blood samples will be taken for inflammatory markers analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changing on appetite markers (i.e. ghrelin, cholecystokinin, glucagon-like peptide-1, gastric inhibitory polypeptide, peptide YY, amylin, pancreatic polypeptide) after treatment with Brazilian fruits peel</measure>
    <time_frame>Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min.</time_frame>
    <description>The venous serum blood samples will be taken for appetite markers analysis</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Control drink</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>300 ml control drink containing equal amount of total fiber and pectine as Brazilian fruit drink, acute study / one time administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Brazilian fruit peel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>300 ml test drink containing Brazilian fruit peel flour, acute study / one time administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Negative control drink</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>300 ml control drink without containing amount of total fiber and pectine as Brazilian fruit drink, acute study / one time administration</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Control drink</intervention_name>
    <description>As a control, subjects are asked to consume 300 ml control drinks containing equal amount of total fiber and pectine as Brazilian fruit drink. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.</description>
    <arm_group_label>Control drink</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Brazilian fruit peel flour</intervention_name>
    <description>In this study, subjects are asked to consume 300 ml beverage drinks contain certain amounts of Brazilian fruit peel flour. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.</description>
    <arm_group_label>Brazilian fruit peel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Negative control drink</intervention_name>
    <description>As a negative control, subjects are asked to consume 300 ml control drinks without containing amount of total fiber and pectine as Brazilian fruit drink. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.</description>
    <arm_group_label>Negative control drink</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy males and females&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
          -  BMI 20 - 28 kg/m2 with weight change &lt;3 kg latest 2 months&#xD;
&#xD;
          -  Must be able to accept plant-based foods/drinks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Below 18 years&#xD;
&#xD;
          -  Uncomfortable speaking English and/or difficulties in understanding spoken English&#xD;
&#xD;
          -  Smoking or using snuff&#xD;
&#xD;
          -  Vegetarian or vegan&#xD;
&#xD;
          -  Stressed by venous blood sampling or previous experience of being difficult to&#xD;
             cannulate&#xD;
&#xD;
          -  Receiving any drug treatment that may influence the study outcomes&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elin Östman, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lund University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Glaucia Lima, MSc</last_name>
    <role>Study Chair</role>
    <affiliation>Lund University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yoghatama Cindya Zanzer, MSc</last_name>
    <role>Study Chair</role>
    <affiliation>Lund University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Antidiabetic Food Centre (Medicon Village) - Lund University</name>
      <address>
        <city>Lund</city>
        <state>Skåne</state>
        <zip>221 00</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <last_update_submitted>September 6, 2016</last_update_submitted>
  <last_update_submitted_qc>September 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lund University</investigator_affiliation>
    <investigator_full_name>Elin Östman</investigator_full_name>
    <investigator_title>Assoc. Prof, PhD</investigator_title>
  </responsible_party>
  <keyword>Brazilian fruit peel</keyword>
  <keyword>Functional food</keyword>
  <keyword>Cardiometabolic risk</keyword>
  <keyword>Metabolic syndrome</keyword>
  <keyword>Inflammation</keyword>
  <keyword>Appetite</keyword>
  <keyword>Gut hormone</keyword>
  <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/NCT02245906
org study id: BRASIL-MET
nct id: NCT02245906
lead sponsor: 
collaborator: 
has dmc: No
The purpose of the study was to investigate how Brazilian fruits peel affect
      acute/postprandial glucose and insulin responses, inflammatory markers, appetite control
      peptides, antioxidative capacity, as well as subjective appetite ratings (VAS-visual analogue
      scales) in healthy volunteers. We hypothesize that certain Brazilian fruits peel added to a
      standardized meal will improve postprandial glucose tolerance and other metabolic biomarkers
      in healthy volunteers, compared with a similar meal without the corresponding plant
      materials.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Changing on blood glucose concentration after treatment with brazilian fruits peel
time frame: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min
description: The capillary blood samples will be taken for blood glucose analysis
measure: Changing on subjective appetite ratings after treatment with Brazilian fruits peel
time frame: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min.
description: Appetite will be assessed using standard subjective 100 mm VAS (visual analogue scale) at time intervals throughout each visit
measure: Identify plasma metabolite profile (untargeted approach) after treatment with Brazilian fruits peel
time frame: Prior to the initial intervention at 0 min and after intervention at 60, 90, 120, 180 min.
description: Metabolite profile will be analyzed using Liquid Chromatography-Mass Spectrometry based methods
measure: Changing on insulin after treatment with Brazilian fruits peel
time frame: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min.
description: The venous serum blood samples will be taken for insulin analysis
measure: Changing on inflammatory markers (i.e. interleukin-6, interleukin-8, tumor necrosis factor-alpha, necrosis factor kappa-beta, adiponectin and C-reactive protein) after treatment with Brazilian fruits peel
time frame: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min.
description: The venous serum blood samples will be taken for inflammatory markers analysis
measure: Changing on appetite markers (i.e. ghrelin, cholecystokinin, glucagon-like peptide-1, gastric inhibitory polypeptide, peptide YY, amylin, pancreatic polypeptide) after treatment with Brazilian fruits peel
time frame: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min.
description: The venous serum blood samples will be taken for appetite markers analysis
arm group label: Control drink
arm group type: Placebo Comparator
description: 300 ml control drink containing equal amount of total fiber and pectine as Brazilian fruit drink, acute study / one time administration
arm group label: Brazilian fruit peel
arm group type: Experimental
description: 300 ml test drink containing Brazilian fruit peel flour, acute study / one time administration
arm group label: Negative control drink
arm group type: Placebo Comparator
description: 300 ml control drink without containing amount of total fiber and pectine as Brazilian fruit drink, acute study / one time administration
intervention type: Dietary Supplement
intervention name: Control drink
description: As a control, subjects are asked to consume 300 ml control drinks containing equal amount of total fiber and pectine as Brazilian fruit drink. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.
arm group label: Control drink
intervention type: Dietary Supplement
intervention name: Brazilian fruit peel flour
description: In this study, subjects are asked to consume 300 ml beverage drinks contain certain amounts of Brazilian fruit peel flour. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.
arm group label: Brazilian fruit peel
intervention type: Dietary Supplement
intervention name: Negative control drink
description: As a negative control, subjects are asked to consume 300 ml control drinks without containing amount of total fiber and pectine as Brazilian fruit drink. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.
arm group label: Negative control drink
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Elin Östman, PhD
role: Principal Investigator
affiliation: Lund University
last name: Glaucia Lima, MSc
role: Study Chair
affiliation: Lund University
last name: Yoghatama Cindya Zanzer, MSc
role: Study Chair
affiliation: Lund University
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Lund University
investigator full name: Elin Östman
investigator title: Assoc. Prof, PhD
sharing ipd: No