<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/NCT02204384</url>
  </required_header>
  <id_info>
    <org_study_id>140161</org_study_id>
    <nct_id>NCT02204384</nct_id>
  </id_info>
  <brief_title>Glycemic and Insulinemic Response With Different Sources of Soluble Fiber in Patients Type 2 Diabetes Mellitus</brief_title>
  <official_title>Plasma Glucose and Insulin Responses After Consumption of Breakfasts With Different Sources of Soluble Fiber in Type 2 Diabetes Patients: a Randomized Crossover Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Clinicas de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Federal University of Rio Grande do Sul</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital de Clinicas de Porto Alegre</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare the acute effect of soluble fiber intake from foods or supplement after a common&#xD;
      meal on postprandial plasma glucose and insulin in patients with type 2 diabetes. The&#xD;
      hypothesis is a meal with a high content of soluble fiber from food determines glycemic and&#xD;
      insulinemic response similar to a meal with a high content of soluble fiber from supplement&#xD;
      sources.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Three breakfasts (high amount of fiber from diet food sources - HFD, high amount of soluble&#xD;
      fiber from guar gum supplement - HFS and usual amount of fiber -UF), isocaloric and similar&#xD;
      distribution of carbohydrates, proteins and lipids, the order of breakfasts randomly&#xD;
      determined. Meals HFD and HFS have the same amount of fiber from different sources, origin in&#xD;
      food and supplement respectively. Meal UF consist of the same foods meal HFS, but without the&#xD;
      use of soluble fiber supplement and white bread instead of rye bread (low fiber content in&#xD;
      relation to meals HFD and HFS). The supplement (Sachet 5g - Fiber Mais ®: 60% guar gum and&#xD;
      40% inulin) will be added to the plain water to meal HFD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">March 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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area Under the Curve (AUC 0-180min) for glycemic and insulinemic responses</measure>
    <time_frame>Prior to the initial meal A, B and C and 30, 60,120,180 minutes postmeal</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Dietary Modification</condition>
  <condition>Diabetes Mellitus Type 2</condition>
  <condition>Insulin Tolerance</condition>
  <condition>Diabetic Blood Glucose Monitoring</condition>
  <arm_group>
    <arm_group_label>HFD Meal: high fiber from food</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HFD Meal: high amount of fiber from diet food sources (total fiber 9.7g; soluble fiber 5.4g)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HFS Meal: High fiber from supplement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HFS Meal: high amount of soluble fiber from guar gum supplement (HFS; total fiber 9.1g; soluble fiber 5.4g) - Fiber Mais, Nestlé</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UF Meal: usual amount of fiber</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>UF Meal: usual amount of fiber (total fiber 2.4g; soluble fiber 0.8g)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>HFD Meal: High fiber from food</intervention_name>
    <description>High amount of fiber from diet food sources (HFD; total fiber 9.7g; soluble fiber 5.4g)</description>
    <arm_group_label>HFD Meal: high fiber from food</arm_group_label>
    <other_name>HFD</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>HFS Meal: High fiber from supplement</intervention_name>
    <description>High amount of soluble fiber from guar gum supplement (HFS; total fiber 9.1g; soluble fiber 5.4g) - sachet 5 g Fiber Mais, Nestlé Brasil, São Paulo, BR</description>
    <arm_group_label>HFS Meal: High fiber from supplement</arm_group_label>
    <other_name>HFS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>UF Meal: usual amount of fiber</intervention_name>
    <description>Usual amount of fiber (UF; total fiber 2.4g; soluble fiber 0.8g)</description>
    <arm_group_label>UF Meal: usual amount of fiber</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with type 2 diabetes&#xD;
&#xD;
          -  Body Mass Index (BMI) &lt;= 35 kg / m²&#xD;
&#xD;
          -  Hemoglobin A1c (HbA1c) &lt;= 9%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Serum creatinine &gt;2.0 mg/dL&#xD;
&#xD;
          -  Digestive diseases (e.g. malabsorption)&#xD;
&#xD;
          -  Severe autonomic neuropathy (presence of symptomatic postural hypotension,&#xD;
             gastroparesis, diabetic diarrhea)&#xD;
&#xD;
          -  Recent cardiovascular event&#xD;
&#xD;
          -  Cachexia&#xD;
&#xD;
          -  Psychiatric disorder with impairment of understanding&#xD;
&#xD;
          -  Participating in other research protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mirela J Azevedo, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital de Clínicas de Porto Alegre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital de Clínicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande do Sul</state>
        <zip>90035-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>February 13, 2017</last_update_submitted>
  <last_update_submitted_qc>February 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital de Clinicas de Porto Alegre</investigator_affiliation>
    <investigator_full_name>Mirela Jobim de Azevedo</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Dietary fiber</keyword>
  <keyword>Dietary Supplements</keyword>
  <keyword>Type 2 diabetes</keyword>
  <keyword>Postprandial Period</keyword>
  <keyword>Plasma insulin</keyword>
  <keyword>Plasma glucose</keyword>
  <keyword>Area Under Curve</keyword>
  <keyword>Soluble fiber</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02204384
org study id: 140161
nct id: NCT02204384
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
To compare the acute effect of soluble fiber intake from foods or supplement after a common
      meal on postprandial plasma glucose and insulin in patients with type 2 diabetes. The
      hypothesis is a meal with a high content of soluble fiber from food determines glycemic and
      insulinemic response similar to a meal with a high content of soluble fiber from supplement
      sources.
Three breakfasts (high amount of fiber from diet food sources - HFD, high amount of soluble
      fiber from guar gum supplement - HFS and usual amount of fiber -UF), isocaloric and similar
      distribution of carbohydrates, proteins and lipids, the order of breakfasts randomly
      determined. Meals HFD and HFS have the same amount of fiber from different sources, origin in
      food and supplement respectively. Meal UF consist of the same foods meal HFS, but without the
      use of soluble fiber supplement and white bread instead of rye bread (low fiber content in
      relation to meals HFD and HFS). The supplement (Sachet 5g - Fiber Mais ®: 60% guar gum and
      40% inulin) will be added to the plain water to meal HFD.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Area Under the Curve (AUC 0-180min) for glycemic and insulinemic responses
time frame: Prior to the initial meal A, B and C and 30, 60,120,180 minutes postmeal
arm group label: HFD Meal: high fiber from food
arm group type: Experimental
description: HFD Meal: high amount of fiber from diet food sources (total fiber 9.7g; soluble fiber 5.4g)
arm group label: HFS Meal: High fiber from supplement
arm group type: Experimental
description: HFS Meal: high amount of soluble fiber from guar gum supplement (HFS; total fiber 9.1g; soluble fiber 5.4g) - Fiber Mais, Nestlé
arm group label: UF Meal: usual amount of fiber
arm group type: Experimental
description: UF Meal: usual amount of fiber (total fiber 2.4g; soluble fiber 0.8g)
intervention type: Other
intervention name: HFD Meal: High fiber from food
description: High amount of fiber from diet food sources (HFD; total fiber 9.7g; soluble fiber 5.4g)
arm group label: HFD Meal: high fiber from food
other name: HFD
intervention type: Dietary Supplement
intervention name: HFS Meal: High fiber from supplement
description: High amount of soluble fiber from guar gum supplement (HFS; total fiber 9.1g; soluble fiber 5.4g) - sachet 5 g Fiber Mais, Nestlé Brasil, São Paulo, BR
arm group label: HFS Meal: High fiber from supplement
other name: HFS
intervention type: Other
intervention name: UF Meal: usual amount of fiber
description: Usual amount of fiber (UF; total fiber 2.4g; soluble fiber 0.8g)
arm group label: UF Meal: usual amount of fiber
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mirela J Azevedo, PhD
role: Principal Investigator
affiliation: Hospital de Clínicas de Porto Alegre
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Hospital de Clinicas de Porto Alegre
investigator full name: Mirela Jobim de Azevedo
investigator title: PhD
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Undecided