<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/NCT03257059</url>
  </required_header>
  <id_info>
    <org_study_id>2017/00537</org_study_id>
    <nct_id>NCT03257059</nct_id>
  </id_info>
  <brief_title>Breakfast Consumption and Its Effects on Glycemic, Insulinemic and Non-Esterified Fatty Acids Responses</brief_title>
  <acronym>BEGIN</acronym>
  <official_title>Breakfast Consumption and Its Effects on Glycemic, Insulinemic and Non-Esterified Fatty Acids Responses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>JeyaKumar Henry</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>General Mills</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Clinical Nutrition Research Centre, Singapore</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to determine whether eating breakfast or having no breakfast has&#xD;
      subsequent beneficial health effects, specifically in relation to glycemic response&#xD;
      throughout the day and postprandial insulin and non-esterified fatty acids (NEFA) responses 6&#xD;
      hours after breakfast/lunch.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a randomised, crossover study with two treatments in total. 1.) Subjects given&#xD;
      with breakfast, 2.) Subjects not given breakfast. Each of the two test visits will last for&#xD;
      approximately 9 hour (spanning over 3 days), during which the following will take place: On&#xD;
      Day 1, subjects will come to have the continuous glucose monitoring (CGMS) system inserted.&#xD;
      CGMS will be used to measure 24 hour blood glucose concentrations. On Day 2, an indwelling&#xD;
      catheter will be inserted into the ante cubital fossa or forearm vein of one arm and will be&#xD;
      kept patent. One fasting blood sample (baseline; 4 milliliters of venous blood) will be&#xD;
      collected. Participants with breakfast treatment will then consume the test meal within 15&#xD;
      minutes. Subsequently, blood samples will be taken at 15, 30, 45, 60, 90, 120, 150 and 180&#xD;
      minutes.At time 180 minutes, participants will be given a standardized lunch to be consumed&#xD;
      within 30 minutes. Blood samples will be taken after lunch at 210, 240, 270, 300, 330 and 360&#xD;
      minutes. On Day 3, subjects will need to come for removal of the CGMS sensor. Subjects will&#xD;
      come to the CNRC again for the 2nd test visit, with at least 3 days wash-out in-between&#xD;
      visits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 25, 2017</start_date>
  <completion_date type="Actual">March 28, 2019</completion_date>
  <primary_completion_date type="Actual">March 28, 2019</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>
    <intervention_model_description>Randomised, crossover study with two treatments</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glycemic response</measure>
    <time_frame>1.5 days</time_frame>
    <description>Using continuous glucose monitoring system</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Insulin response</measure>
    <time_frame>6 hours</time_frame>
    <description>Postprandial after treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Non-esterified fatty acids (NEFA) response</measure>
    <time_frame>6 hours</time_frame>
    <description>Postprandial after treatment</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Glycemic Response</condition>
  <arm_group>
    <arm_group_label>Breakfast</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subject given standardized breakfast (glutinous rice) to test blood glucose response</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No breakfast</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subject not given breakfast to test blood glucose response</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Breakfast</intervention_name>
    <description>Glutinous rice (75 grams of available carbohydrate)</description>
    <arm_group_label>Breakfast</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Breakfast</intervention_name>
    <description>No food to be served in the morning</description>
    <arm_group_label>No breakfast</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chinese males&#xD;
&#xD;
          -  BMI above 23.0 kg/m2&#xD;
&#xD;
          -  Age between 40-65 years&#xD;
&#xD;
          -  Normal blood pressure (&lt;140/90 mmHg)&#xD;
&#xD;
          -  Fasting blood glucose of ≥5.6 mmol/L&#xD;
&#xD;
          -  Self-reported regular breakfast consumers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have known glucose-6-phosphate dehydrogenase (G6PD) deficiency&#xD;
&#xD;
          -  major chronic disease such as heart disease, cancer or diabetes mellitus&#xD;
&#xD;
          -  taking insulin or drugs known to affect glucose metabolism&#xD;
&#xD;
          -  Intentionally restrict food intake&#xD;
&#xD;
          -  major medical or surgical event requiring hospitalization within the preceding 3&#xD;
             months&#xD;
&#xD;
          -  Have taken antibiotics for 3 months before the study period&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Overnight shift workers&#xD;
&#xD;
          -  Any known food allergy (eg. anaphylaxis to peanuts)&#xD;
&#xD;
          -  Having active Tuberculosis (TB) or currently receiving treatment for TB&#xD;
&#xD;
          -  Any known Chronic infection or known to suffer from or have previously suffered from&#xD;
             or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human&#xD;
             Immunodeficiency Virus (HIV)&#xD;
&#xD;
          -  Being a member of the research team or their immediate family members. Immediate&#xD;
             family member is defined as a spouse, parent, child, or sibling, whether biological or&#xD;
             legally adopted.&#xD;
&#xD;
          -  Enrolled in a concurrent research study judged not to be scientifically or medically&#xD;
             compatible with the study of the CNRC.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Clinical Nutrition Research Centre</name>
      <address>
        <city>Singapore</city>
        <zip>117599</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>May 10, 2019</last_update_submitted>
  <last_update_submitted_qc>May 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Clinical Nutrition Research Centre, Singapore</investigator_affiliation>
    <investigator_full_name>JeyaKumar Henry</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <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/NCT03257059
org study id: 2017/00537
nct id: NCT03257059
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to determine whether eating breakfast or having no breakfast has
      subsequent beneficial health effects, specifically in relation to glycemic response
      throughout the day and postprandial insulin and non-esterified fatty acids (NEFA) responses 6
      hours after breakfast/lunch.
This will be a randomised, crossover study with two treatments in total. 1.) Subjects given
      with breakfast, 2.) Subjects not given breakfast. Each of the two test visits will last for
      approximately 9 hour (spanning over 3 days), during which the following will take place: On
      Day 1, subjects will come to have the continuous glucose monitoring (CGMS) system inserted.
      CGMS will be used to measure 24 hour blood glucose concentrations. On Day 2, an indwelling
      catheter will be inserted into the ante cubital fossa or forearm vein of one arm and will be
      kept patent. One fasting blood sample (baseline; 4 milliliters of venous blood) will be
      collected. Participants with breakfast treatment will then consume the test meal within 15
      minutes. Subsequently, blood samples will be taken at 15, 30, 45, 60, 90, 120, 150 and 180
      minutes.At time 180 minutes, participants will be given a standardized lunch to be consumed
      within 30 minutes. Blood samples will be taken after lunch at 210, 240, 270, 300, 330 and 360
      minutes. On Day 3, subjects will need to come for removal of the CGMS sensor. Subjects will
      come to the CNRC again for the 2nd test visit, with at least 3 days wash-out in-between
      visits.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Randomised, crossover study with two treatments
primary purpose: Other
masking: None (Open Label)
measure: Glycemic response
time frame: 1.5 days
description: Using continuous glucose monitoring system
measure: Insulin response
time frame: 6 hours
description: Postprandial after treatment
measure: Non-esterified fatty acids (NEFA) response
time frame: 6 hours
description: Postprandial after treatment
arm group label: Breakfast
arm group type: Experimental
description: Subject given standardized breakfast (glutinous rice) to test blood glucose response
arm group label: No breakfast
arm group type: Experimental
description: Subject not given breakfast to test blood glucose response
intervention type: Other
intervention name: Breakfast
description: Glutinous rice (75 grams of available carbohydrate)
arm group label: Breakfast
intervention type: Other
intervention name: No Breakfast
description: No food to be served in the morning
arm group label: No breakfast
criteria: 
gender: Male
minimum age: 40 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Singapore
responsible party type: Sponsor-Investigator
investigator affiliation: Clinical Nutrition Research Centre, Singapore
investigator full name: JeyaKumar Henry
investigator title: Principal Investigator
sharing ipd: No