<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/NCT04417504</url>
  </required_header>
  <id_info>
    <org_study_id>MobFood</org_study_id>
    <nct_id>NCT04417504</nct_id>
  </id_info>
  <brief_title>Metabolic and Prolonged Satiety Effects of a Breakfast Kit</brief_title>
  <official_title>Metabolic and Prolonged Satiety Effects of a Breakfast Kit: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade do Porto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Center for Health Technology and Services Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>NOVA Medical School</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidade do Porto</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>
      The mobilizing programme MobFood - mobilizing scientific knoweledge and technology to answer&#xD;
      the current nutrition market challenges - is formed by a consortium of 47 collaborative&#xD;
      entities, between the industry and ENESIIs (Entidades Não Empresariais do Sistema de&#xD;
      Investigação e Inovação) and is financed by Structural European Funds of Investment.&#xD;
&#xD;
      The project is currently investigating and undertaking collaborative scientific and&#xD;
      technological strategies based on R&amp;D and innovation, in order to boost and promote a more&#xD;
      competitive national food industry, capable of overcoming the current challenges, including&#xD;
      those of the Millennial Generation. This group is particularly conscious of the impact of&#xD;
      food behaviour and food choices on health but extremely vulnerable to dietary imbalance.&#xD;
      Strategies to improve Millenials' nutrition while providing conscious food products are&#xD;
      needed.&#xD;
&#xD;
      This study is a randomised, cross-over controlled trial designed to test the metabolic&#xD;
      effect, particularly in terms of appetite control and glycaemic response of a breakfast kit&#xD;
      (nutritionally balanced and innovative), recently developed as part of the collaborative&#xD;
      project MobFood_PPS4.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 1, 2020</start_date>
  <completion_date type="Anticipated">October 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2020</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Differences in the incremental area under the curve (iAUC, mg/dl*min) for glucose response between the 2 arms</measure>
    <time_frame>at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)</time_frame>
    <description>The iAUC for glucose will be calculated based on the concentration curve following consumption of the test and control products, over 2h</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Differences in the iAUC (pmol/l*min) for glucagon-like peptide-1 (GLP-1) between the 2 arms</measure>
    <time_frame>at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)</time_frame>
    <description>The iAUC for GLP-1 will be calculated based on the concentration curve following consumption of the test and control products, over 3h</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Differences in the iAUC (pmol/l*min) for peptide YY (PYY) between the 2 arms</measure>
    <time_frame>at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)</time_frame>
    <description>The iAUC for PYY will be calculated based on the concentration curve following consumption of the test and control products, over 3h</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Differences in the iAUC (pmol/l*min) for cholecystokinin (CKK) between the 2 arms</measure>
    <time_frame>at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)</time_frame>
    <description>The iAUC for CKK will be calculated based on the concentration curve following consumption of the test and control products, over 3h</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Differences in the iAUC (pmol/l*min) for ghrelin between the 2 arms</measure>
    <time_frame>at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)</time_frame>
    <description>The iAUC for ghrelin will be calculated based on the concentration curve following consumption of test and control products, over 3h</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Differences in the iAUC (pmol/l*min) for glucagon between the 2 arms</measure>
    <time_frame>at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)</time_frame>
    <description>The iAUC for glucagon will be calculated based on the concentration curve following consumption of the test and control products, over 3h</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Differences in the iAUC (mg/dl*min) for triacylglycerides (TG) between 2 arms</measure>
    <time_frame>at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)</time_frame>
    <description>The iAUC for TG will be calculated based on the concentration curve following consumption of the test and control products, over 3h</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in the iAUC for (mmol/l*min) non-esterified fatty acids (NEFA) between 2 arms</measure>
    <time_frame>at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)</time_frame>
    <description>The iAUC for NEFA will be calculated based on the concentration curve following consumption of the test and control products, over 3h</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in subjective feelings of hunger/satiety between the 2 arms</measure>
    <time_frame>at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)</time_frame>
    <description>Difference in subjective feelings of hunger/satiety from fasting state to post-prandial state with the consumption of the test and control products</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Diet Habit</condition>
  <arm_group>
    <arm_group_label>MobFood breakfast kit</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control isocaloric breakfast</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MobFood breakfast kit</intervention_name>
    <description>Cereal biscuit with orange fruit, cheese with fruit preparation and beverage based on oat, milk and mocha (without added sugar), specifically developed for the project MobFood_PPS4.</description>
    <arm_group_label>MobFood breakfast kit</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control isocaloric breakfast</intervention_name>
    <description>White bread, butter and milk.</description>
    <arm_group_label>Control isocaloric breakfast</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female;&#xD;
&#xD;
          -  Born between 1981 and 1996;&#xD;
&#xD;
          -  Body mass index (BMI) between 18.5 kg/m2 and 24.9 kg/m2;&#xD;
&#xD;
          -  Normoglycemic according to American Diabetes Association criteria [Fasting Plasma&#xD;
             Glucose &lt; 100 mg/dl, 2-h plasma glucose value during a 75 g oral glucose tolerance&#xD;
             test (OGTT) &lt; 140 mg/dl)];&#xD;
&#xD;
          -  Healthy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Overweight or obese (BMI ≥ 25,0 kg/m2);&#xD;
&#xD;
          -  Recent body weight loss/gain &gt;10%, within previous 3 months;&#xD;
&#xD;
          -  Being on a weight loss/other special diet (e.g. Paleo diet, Atkins diet, flexitarian&#xD;
             diet or ketogenic diet), within previous 3 months;&#xD;
&#xD;
          -  Clinically significant illness, including:&#xD;
&#xD;
        type 1 or type 2 diabetes; liver disease e.g. cirrhosis; malignancy; pancreatitis or other&#xD;
        malabsorption; gastrointestinal disorders e. g. intestinal bowel disorder, celiac disease;&#xD;
        previous weight loss surgery e.g. bariatric surgery; chronic respiratory, neurological,&#xD;
        psychiatric, musculoskeletal diseases/conditions; diagnosed eating disorders.&#xD;
&#xD;
          -  Individuals who don't regularly consume breakfast;&#xD;
&#xD;
          -  Having taken antibiotics within the 12 weeks prior to beginning the study;&#xD;
&#xD;
          -  Taking other medication that could potentially affect body weight, glucose metabolism&#xD;
             and/or appetite (e.g. GLP-1 analogues);&#xD;
&#xD;
          -  Being engaged in competitive sports;&#xD;
&#xD;
          -  Having &gt;14 or &gt;8 (males and females, respectively) alcoholic units/week; misuse of&#xD;
             drugs;&#xD;
&#xD;
          -  Having donated blood within one month prior to the beginning of the study;&#xD;
&#xD;
          -  Nut or milk allergy, or other food allergy or intolerance that would compromise&#xD;
             compliance with the study protocol;&#xD;
&#xD;
          -  Pregnant or breastfeeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>23 Years</minimum_age>
    <maximum_age>38 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Conceição Calhau, PhD</last_name>
    <phone>00351 218803035</phone>
    <phone_ext>20401</phone_ext>
    <email>ccalhau@nms.unl.pt</email>
  </overall_contact>
  <location>
    <facility>
      <name>NOVA Medical School, NOVA University of Lisbon</name>
      <address>
        <city>Lisbon</city>
        <country>Portugal</country>
      </address>
    </facility>
    <contact>
      <last_name>Conceição Calhau, PhD</last_name>
      <phone>+351918482491</phone>
      <email>mobfood@nms.unl.pt</email>
    </contact>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 4, 2020</last_update_submitted>
  <last_update_submitted_qc>June 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04417504
org study id: MobFood
nct id: NCT04417504
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The mobilizing programme MobFood - mobilizing scientific knoweledge and technology to answer
      the current nutrition market challenges - is formed by a consortium of 47 collaborative
      entities, between the industry and ENESIIs (Entidades Não Empresariais do Sistema de
      Investigação e Inovação) and is financed by Structural European Funds of Investment.

      The project is currently investigating and undertaking collaborative scientific and
      technological strategies based on R&D and innovation, in order to boost and promote a more
      competitive national food industry, capable of overcoming the current challenges, including
      those of the Millennial Generation. This group is particularly conscious of the impact of
      food behaviour and food choices on health but extremely vulnerable to dietary imbalance.
      Strategies to improve Millenials' nutrition while providing conscious food products are
      needed.

      This study is a randomised, cross-over controlled trial designed to test the metabolic
      effect, particularly in terms of appetite control and glycaemic response of a breakfast kit
      (nutritionally balanced and innovative), recently developed as part of the collaborative
      project MobFood_PPS4.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Differences in the incremental area under the curve (iAUC, mg/dl*min) for glucose response between the 2 arms
time frame: at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)
description: The iAUC for glucose will be calculated based on the concentration curve following consumption of the test and control products, over 2h
measure: Differences in the iAUC (pmol/l*min) for glucagon-like peptide-1 (GLP-1) between the 2 arms
time frame: at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)
description: The iAUC for GLP-1 will be calculated based on the concentration curve following consumption of the test and control products, over 3h
measure: Differences in the iAUC (pmol/l*min) for peptide YY (PYY) between the 2 arms
time frame: at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)
description: The iAUC for PYY will be calculated based on the concentration curve following consumption of the test and control products, over 3h
measure: Differences in the iAUC (pmol/l*min) for cholecystokinin (CKK) between the 2 arms
time frame: at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)
description: The iAUC for CKK will be calculated based on the concentration curve following consumption of the test and control products, over 3h
measure: Differences in the iAUC (pmol/l*min) for ghrelin between the 2 arms
time frame: at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)
description: The iAUC for ghrelin will be calculated based on the concentration curve following consumption of test and control products, over 3h
measure: Differences in the iAUC (pmol/l*min) for glucagon between the 2 arms
time frame: at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)
description: The iAUC for glucagon will be calculated based on the concentration curve following consumption of the test and control products, over 3h
measure: Differences in the iAUC (mg/dl*min) for triacylglycerides (TG) between 2 arms
time frame: at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)
description: The iAUC for TG will be calculated based on the concentration curve following consumption of the test and control products, over 3h
measure: Differences in the iAUC for (mmol/l*min) non-esterified fatty acids (NEFA) between 2 arms
time frame: at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)
description: The iAUC for NEFA will be calculated based on the concentration curve following consumption of the test and control products, over 3h
measure: Differences in subjective feelings of hunger/satiety between the 2 arms
time frame: at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)
description: Difference in subjective feelings of hunger/satiety from fasting state to post-prandial state with the consumption of the test and control products
arm group label: MobFood breakfast kit
arm group type: Experimental
arm group label: Control isocaloric breakfast
arm group type: Experimental
intervention type: Other
intervention name: MobFood breakfast kit
description: Cereal biscuit with orange fruit, cheese with fruit preparation and beverage based on oat, milk and mocha (without added sugar), specifically developed for the project MobFood_PPS4.
arm group label: MobFood breakfast kit
intervention type: Other
intervention name: Control isocaloric breakfast
description: White bread, butter and milk.
arm group label: Control isocaloric breakfast
criteria: 
gender: All
minimum age: 23 Years
maximum age: 38 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Conceição Calhau, PhD
phone: 00351 218803035
phone ext: 20401
email: ccalhau@nms.unl.pt
facility: 
contact: 
country: Portugal
responsible party type: Sponsor
sharing ipd: Undecided