<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/NCT03240757</url>
  </required_header>
  <id_info>
    <org_study_id>Colazioni/1</org_study_id>
    <nct_id>NCT03240757</nct_id>
  </id_info>
  <brief_title>Metabolic and Functional Impact of Various Breakfast Models</brief_title>
  <official_title>Metabolic Responses of a Single Bout of Low-intensity Exercise Following Mixed Meals in Healthy Individuals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ospedale San Donato</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Milan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ospedale San Donato</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>
      In the present study the investigators compared the hormonal and metabolic effects of three&#xD;
      meal loads very popular among Italian eating habits, both in the resting- and exercising&#xD;
      state. Given the lack of time is considered a common barrier to exercise adherence, we wanted&#xD;
      to identify a low dose of exercise capable to produce health benefits in the post-absorptive&#xD;
      status elicited by three commonly consumed meal-models in Mediterranean countries. To this&#xD;
      end, healthy young volunteers firstly underwent an oral glucose tolerance test (OGTT) and&#xD;
      three meal tolerance tests. Secondly, in an extra set of experiments, subjects cycled at low&#xD;
      intensity for the last 20 minutes of the same glucose/meal tolerance test. Glycemia,&#xD;
      insulinemia, ghrelinemia, lipidemia, and satiety were measured throughout OGTT and each&#xD;
      test-meal load.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators evaluated postprandial responses (glucose, insulin, ghrelin, free fatty&#xD;
      acids (FFA)) elicited by three diverse test-meal loads followed by a 20-min bout of&#xD;
      low-intensity aerobic exercise were investigated. All subjects underwent a 50-g OGTT (A) and&#xD;
      3 test-meal loads: milk and cereals (B1); milk, apple and chocolate cream-filled sponge cake&#xD;
      (B2); milk, bread, apple and hazelnut chocolate cream (B3). In the exercise trial,&#xD;
      participants cycled for 20 minutes at 40% VO2max, 100 minutes after load ingestion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 14, 2009</start_date>
  <completion_date type="Actual">May 28, 2010</completion_date>
  <primary_completion_date type="Actual">May 28, 2010</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>Parallel Assignment</intervention_model>
    <intervention_model_description>randomized-crossover in healthy subjects</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma glucose responses of a single bout of low-intensity exercise following mixed meals in healthy individuals.</measure>
    <time_frame>The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).</time_frame>
    <description>Postprandial glycemic responses elicited by three diverse test-meal loads followed by a 20-min bout of low-intensity aerobic exercise.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma insulin responses of a single bout of low-intensity exercise following mixed meals in healthy individuals.</measure>
    <time_frame>The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).</time_frame>
    <description>Postprandial insulinemic responses elicited by three diverse test-meal loads followed by a 20-min bout of low-intensity aerobic exercise.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma ghrelin responses of a single bout of low-intensity exercise following mixed meals in healthy individuals.</measure>
    <time_frame>The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).</time_frame>
    <description>Postprandial ghrelinemic responses elicited by three diverse test-meal loads followed by a 20-min bout of low-intensity aerobic exercise.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma free fatty acids (FFA) responses of a single bout of low-intensity exercise following mixed meals in healthy individuals.</measure>
    <time_frame>The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).</time_frame>
    <description>Postprandial plasma FFA responses elicited by three diverse test-meal loads followed by a 20-min bout of low-intensity aerobic exercise.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Metabolism and Nutrition Disorder</condition>
  <arm_group>
    <arm_group_label>Breakfast without exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Each subject of the same arm underwent 2 interventions: breakfast with/without exercise</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Breakfast with exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each subject of the same arm underwent 2 interventions: breakfast with/without exercise</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Breakfast</intervention_name>
    <description>All subjects received a standard 75-g OGTT to assess eligibility for the study. The 19 subjects matching the inclusion criteria completed 2 experimental trials: resting and exercise. During the resting trial, all subjects underwent an OGTT (50-g: A) and 3 meal tolerance tests [one for each breakfast tested: B1 = milk (125ml) and cereals (30g); B2 = milk (220ml), apple (200g) and chocolate cream-filled sponge cake (30g); B3 = milk (125ml), apple (150g), bread (50g) and hazelnut chocolate cream (15g)]. In the exercise trial, 100 minutes after the glucose/meal ingestion, participants cycled for 20 min at 40% of maximum oxygen uptake.</description>
    <arm_group_label>Breakfast with exercise</arm_group_label>
    <arm_group_label>Breakfast without exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>exercise</intervention_name>
    <description>aerobic exercise at 40% of VO2max, for 20 minutes</description>
    <arm_group_label>Breakfast with exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age between 18 and 40 years&#xD;
&#xD;
          -  normal body weight (BMI =18.5 - 24.9 according to NHLBI)&#xD;
&#xD;
          -  stable diet&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetes, tipe 1 and 2 (ADA criteria)&#xD;
&#xD;
          -  Glucose intolerance (ADA criteria)&#xD;
&#xD;
          -  Dyslipidemia (ATP III according to NCEP)&#xD;
&#xD;
          -  Metabolic syndrome&#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>Livio Luzi, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gruppo San Donato</affiliation>
  </overall_official>
  <results_reference>
    <citation>R Codella, A Caumo, S Benedini, M Adamo, A Ferrulli, C Macrì, I Terruzzi, L Luzi. Metabolic responses of a single bout of low-intensity exercise following mixed meals in healthy individuals. ADA (American Diabetes Association) 77th Scientific Session, 8-13 giugno 2017, San Diego, CA, USA. Diabetes 2017 Jun; 66 (Supplement 1).</citation>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>August 4, 2017</last_update_submitted>
  <last_update_submitted_qc>August 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ospedale San Donato</investigator_affiliation>
    <investigator_full_name>Livio Luzi</investigator_full_name>
    <investigator_title>M.D., Full Professor of Endocrinology</investigator_title>
  </responsible_party>
  <keyword>meal absorption</keyword>
  <keyword>exercise</keyword>
  <keyword>energy balance</keyword>
  <keyword>lipolysis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nutrition Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>De-identified collective participant data for all outcome measures will be made available upon publication</ipd_description>
  </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/NCT03240757
org study id: Colazioni/1
nct id: NCT03240757
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In the present study the investigators compared the hormonal and metabolic effects of three
      meal loads very popular among Italian eating habits, both in the resting- and exercising
      state. Given the lack of time is considered a common barrier to exercise adherence, we wanted
      to identify a low dose of exercise capable to produce health benefits in the post-absorptive
      status elicited by three commonly consumed meal-models in Mediterranean countries. To this
      end, healthy young volunteers firstly underwent an oral glucose tolerance test (OGTT) and
      three meal tolerance tests. Secondly, in an extra set of experiments, subjects cycled at low
      intensity for the last 20 minutes of the same glucose/meal tolerance test. Glycemia,
      insulinemia, ghrelinemia, lipidemia, and satiety were measured throughout OGTT and each
      test-meal load.
The investigators evaluated postprandial responses (glucose, insulin, ghrelin, free fatty
      acids (FFA)) elicited by three diverse test-meal loads followed by a 20-min bout of
      low-intensity aerobic exercise were investigated. All subjects underwent a 50-g OGTT (A) and
      3 test-meal loads: milk and cereals (B1); milk, apple and chocolate cream-filled sponge cake
      (B2); milk, bread, apple and hazelnut chocolate cream (B3). In the exercise trial,
      participants cycled for 20 minutes at 40% VO2max, 100 minutes after load ingestion.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized-crossover in healthy subjects
primary purpose: Other
masking: None (Open Label)
measure: Plasma glucose responses of a single bout of low-intensity exercise following mixed meals in healthy individuals.
time frame: The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).
description: Postprandial glycemic responses elicited by three diverse test-meal loads followed by a 20-min bout of low-intensity aerobic exercise.
measure: Plasma insulin responses of a single bout of low-intensity exercise following mixed meals in healthy individuals.
time frame: The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).
description: Postprandial insulinemic responses elicited by three diverse test-meal loads followed by a 20-min bout of low-intensity aerobic exercise.
measure: Plasma ghrelin responses of a single bout of low-intensity exercise following mixed meals in healthy individuals.
time frame: The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).
description: Postprandial ghrelinemic responses elicited by three diverse test-meal loads followed by a 20-min bout of low-intensity aerobic exercise.
measure: Plasma free fatty acids (FFA) responses of a single bout of low-intensity exercise following mixed meals in healthy individuals.
time frame: The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).
description: Postprandial plasma FFA responses elicited by three diverse test-meal loads followed by a 20-min bout of low-intensity aerobic exercise.
arm group label: Breakfast without exercise
arm group type: Active Comparator
description: Each subject of the same arm underwent 2 interventions: breakfast with/without exercise
arm group label: Breakfast with exercise
arm group type: Experimental
description: Each subject of the same arm underwent 2 interventions: breakfast with/without exercise
intervention type: Dietary Supplement
intervention name: Breakfast
description: All subjects received a standard 75-g OGTT to assess eligibility for the study. The 19 subjects matching the inclusion criteria completed 2 experimental trials: resting and exercise. During the resting trial, all subjects underwent an OGTT (50-g: A) and 3 meal tolerance tests [one for each breakfast tested: B1 = milk (125ml) and cereals (30g); B2 = milk (220ml), apple (200g) and chocolate cream-filled sponge cake (30g); B3 = milk (125ml), apple (150g), bread (50g) and hazelnut chocolate cream (15g)]. In the exercise trial, 100 minutes after the glucose/meal ingestion, participants cycled for 20 min at 40% of maximum oxygen uptake.
arm group label: Breakfast with exercise
arm group label: Breakfast without exercise
intervention type: Other
intervention name: exercise
description: aerobic exercise at 40% of VO2max, for 20 minutes
arm group label: Breakfast with exercise
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Livio Luzi, M.D.
role: Principal Investigator
affiliation: Gruppo San Donato
citation: R Codella, A Caumo, S Benedini, M Adamo, A Ferrulli, C Macrì, I Terruzzi, L Luzi. Metabolic responses of a single bout of low-intensity exercise following mixed meals in healthy individuals. ADA (American Diabetes Association) 77th Scientific Session, 8-13 giugno 2017, San Diego, CA, USA. Diabetes 2017 Jun; 66 (Supplement 1).
responsible party type: Principal Investigator
investigator affiliation: Ospedale San Donato
investigator full name: Livio Luzi
investigator title: M.D., Full Professor of Endocrinology
mesh term: Nutrition Disorders
sharing ipd: No
ipd description: De-identified collective participant data for all outcome measures will be made available upon publication