<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/NCT04403217</url>
  </required_header>
  <id_info>
    <org_study_id>MEDBIOME</org_study_id>
    <nct_id>NCT04403217</nct_id>
  </id_info>
  <brief_title>Effect of MEDiterranean Diet on the microBIOME of Individuals With Type 2 Diabetes</brief_title>
  <acronym>MEDBIOME</acronym>
  <official_title>Effect of MEDiterranean Diet on the microBIOME of Individuals With Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Nova de Lisboa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Nova de Lisboa</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dysbiosis of gut microbiota is associated with the pathophysiology of type 2 diabetes.&#xD;
      Mediterranean diet has been indicated as a dietary pattern that promote the integrity of gut&#xD;
      barrier and that has positive impact in the metabolic control of subjects with type 2&#xD;
      diabetes. This is a 12-week, single-arm clinical study that aims to evaluate if the effect of&#xD;
      Mediterranean diet in metabolic control of these subjects is mediated by gut microbiota.&#xD;
      Subjects will receive personalized nutrition counseling where Mediterranean diet will be&#xD;
      promoted.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Anticipated">September 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2021</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>Changes in intestinal microbiota from baseline to visit 2 and 3</measure>
    <time_frame>1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2) and 12-week post Mediterranean diet intervention (visit 3)</time_frame>
    <description>Bacterial DNA will be extracted from fecal samples. 16SRNA gene will be sequenced by next-generation sequencing (NGS). All the identified bacterial phyla, genus and species will be expressed in percentage</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in HbA1c levels (percent) from baseline to visit 2 and 3</measure>
    <time_frame>1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in HOMA-IR from baseline to visit 2 and 3</measure>
    <time_frame>1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in HOMA-B (percent) from baseline to visit 2 and 3</measure>
    <time_frame>1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in HOMA-S (percent) from baseline to visit 2 and 3</measure>
    <time_frame>1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in fasting capillary blood glucose (mg/dL) from baseline to visit 2 and 3</measure>
    <time_frame>1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in fasting insulin (μU/mL) levels from baseline to visit 2 and 3</measure>
    <time_frame>1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in diet quality from baseline to visit 3</measure>
    <time_frame>1-week post run-in period (baseline), 12-week post Mediterranean diet intervention (visit 3)</time_frame>
    <description>Mediterranean diet adherence will be evaluated using the Mediterranean Diet Adherence Screener (MEDAS) from the PREvención com Dieta MEDiterránea (PREDIMED) study. Responses that are favorable to the adoption of the Mediterranean diet are scored as 1 point, while responses that are unfavorable are scored as 0.&#xD;
The final score ranged between 0 and 14 and a MEDAS score greater than 9 indicates high adherence to the Mediterranean diet.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in food intake from baseline to visit 2 and 3</measure>
    <time_frame>1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)</time_frame>
    <description>3 non-consecutive 24-h dietary food recall using a photographic manual for food quantification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in fasting serum total cholesterol (mg/dL) from baseline to visit 2 and 3</measure>
    <time_frame>1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in fasting serum high-density lipoprotein (HDL) (mg/dL) cholesterol from baseline to visit 2 and 3</measure>
    <time_frame>1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in fasting serum low-density lipoprotein (LDL) (mg/dL) cholesterol from baseline to visit 2 and 3</measure>
    <time_frame>1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in fasting serum triglycerides (mg/dL) from baseline to visit 2 and 3</measure>
    <time_frame>1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in total body fat mass (kg) from baseline to visit 2 and 3</measure>
    <time_frame>1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in free fat mass (kg) from baseline to visit 2 and 3</measure>
    <time_frame>1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in waist perimeter (cm) from baseline to visit 2 and 3</measure>
    <time_frame>1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Individualized structured dietary plan based on MD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will follow an individualized structured dietary plan based on Mediterranean diet for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Individualized structured dietary plan based on MD</intervention_name>
    <description>Participants will follow an individualized structured dietary plan based on Mediterranean diet for 12 weeks</description>
    <arm_group_label>Individualized structured dietary plan based on MD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women diagnosed with type 2 diabetes mellitus, according to the American&#xD;
             Diabetes Association criteria;&#xD;
&#xD;
          -  Ages 40-80 years;&#xD;
&#xD;
          -  Non-smoker;&#xD;
&#xD;
          -  Willing and able to provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetes diagnosed before 40 years old;&#xD;
&#xD;
          -  Changes in oral glycaemic-control medications in the last 3 months;&#xD;
&#xD;
          -  Subjects with HbA1c levels under 6.4% or above 10%;&#xD;
&#xD;
          -  Subjects under insulinotherapy;&#xD;
&#xD;
          -  Subjects under corticotherapy;&#xD;
&#xD;
          -  Subjects with triglycerides levels above 4.52 nmol/L (400 mg/dL);&#xD;
&#xD;
          -  Intake of antibiotics in the last 12 weeks;&#xD;
&#xD;
          -  Subjects with a diagnosis of any digestive disease including functional bowel&#xD;
             disorders such as IBS.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Conceição Calhau</last_name>
    <phone>+351218803000</phone>
    <email>ccalhau@nms.unl.pt</email>
  </overall_contact>
  <location>
    <facility>
      <name>NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa</name>
      <address>
        <city>Lisbon</city>
        <zip>1169-056</zip>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Conceição Calhau</last_name>
      <phone>+351918482491</phone>
      <email>diabeer@nms.unl.pt</email>
    </contact>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>May 25, 2020</last_update_submitted>
  <last_update_submitted_qc>May 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gut microbiota</keyword>
  <keyword>Mediterranean diet</keyword>
  <keyword>Type 2 diabetes</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>
  <!-- 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/NCT04403217
org study id: MEDBIOME
nct id: NCT04403217
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Dysbiosis of gut microbiota is associated with the pathophysiology of type 2 diabetes.
      Mediterranean diet has been indicated as a dietary pattern that promote the integrity of gut
      barrier and that has positive impact in the metabolic control of subjects with type 2
      diabetes. This is a 12-week, single-arm clinical study that aims to evaluate if the effect of
      Mediterranean diet in metabolic control of these subjects is mediated by gut microbiota.
      Subjects will receive personalized nutrition counseling where Mediterranean diet will be
      promoted.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in intestinal microbiota from baseline to visit 2 and 3
time frame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2) and 12-week post Mediterranean diet intervention (visit 3)
description: Bacterial DNA will be extracted from fecal samples. 16SRNA gene will be sequenced by next-generation sequencing (NGS). All the identified bacterial phyla, genus and species will be expressed in percentage
measure: Changes in HbA1c levels (percent) from baseline to visit 2 and 3
time frame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
measure: Changes in HOMA-IR from baseline to visit 2 and 3
time frame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
measure: Changes in HOMA-B (percent) from baseline to visit 2 and 3
time frame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
measure: Changes in HOMA-S (percent) from baseline to visit 2 and 3
time frame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
measure: Changes in fasting capillary blood glucose (mg/dL) from baseline to visit 2 and 3
time frame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
measure: Changes in fasting insulin (μU/mL) levels from baseline to visit 2 and 3
time frame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
measure: Changes in diet quality from baseline to visit 3
time frame: 1-week post run-in period (baseline), 12-week post Mediterranean diet intervention (visit 3)
description: Mediterranean diet adherence will be evaluated using the Mediterranean Diet Adherence Screener (MEDAS) from the PREvención com Dieta MEDiterránea (PREDIMED) study. Responses that are favorable to the adoption of the Mediterranean diet are scored as 1 point, while responses that are unfavorable are scored as 0.
The final score ranged between 0 and 14 and a MEDAS score greater than 9 indicates high adherence to the Mediterranean diet.
measure: Changes in food intake from baseline to visit 2 and 3
time frame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
description: 3 non-consecutive 24-h dietary food recall using a photographic manual for food quantification
measure: Changes in fasting serum total cholesterol (mg/dL) from baseline to visit 2 and 3
time frame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
measure: Changes in fasting serum high-density lipoprotein (HDL) (mg/dL) cholesterol from baseline to visit 2 and 3
time frame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
measure: Changes in fasting serum low-density lipoprotein (LDL) (mg/dL) cholesterol from baseline to visit 2 and 3
time frame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
measure: Changes in fasting serum triglycerides (mg/dL) from baseline to visit 2 and 3
time frame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
measure: Changes in total body fat mass (kg) from baseline to visit 2 and 3
time frame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
measure: Changes in free fat mass (kg) from baseline to visit 2 and 3
time frame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
measure: Changes in waist perimeter (cm) from baseline to visit 2 and 3
time frame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
arm group label: Individualized structured dietary plan based on MD
arm group type: Experimental
description: Participants will follow an individualized structured dietary plan based on Mediterranean diet for 12 weeks
intervention type: Other
intervention name: Individualized structured dietary plan based on MD
description: Participants will follow an individualized structured dietary plan based on Mediterranean diet for 12 weeks
arm group label: Individualized structured dietary plan based on MD
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Conceição Calhau
phone: +351218803000
email: ccalhau@nms.unl.pt
facility: 
status: Recruiting
contact: 
country: Portugal
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2