<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/NCT03005951</url>
  </required_header>
  <id_info>
    <org_study_id>2015-5542</org_study_id>
    <nct_id>NCT03005951</nct_id>
  </id_info>
  <brief_title>The Influence of Breakfast on Hormone Responses and Cognitive Performance</brief_title>
  <official_title>The Influence of Breakfast on Hormone Responses and Cognitive Performance, as Assessed by CTET in Lean and Obese Adolescent Males</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Albert Einstein College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>New York State Department of Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Montefiore Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Albert Einstein College of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</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 purpose of this study is to see what effect skipping breakfast versus consuming breakfast&#xD;
      has on cognitive performance and the hormones responsible for glucose homeostasis in lean and&#xD;
      obese adolescent males. The subjects will be tested on their ability to maintain attention&#xD;
      when given several tasks called continuous temporal expectancy tasks (CTET) and&#xD;
      electrophysiological signals using electroencephalogram (EEG) will be monitored. These two&#xD;
      study groups will be randomized to one of two orders: (A,B) or (B,A) where A = breakfast&#xD;
      intervention and B = no breakfast. There will be a washout period of 7 days in between study&#xD;
      visits.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eating unhealthy foods and not exercising regularly contributes to obesity in children. Other&#xD;
      unhealthy behaviors, such as skipping meals can also lead to obesity. Breakfast is known to&#xD;
      be the most important meal of the day, yet many people skip breakfast. Skipping breakfast can&#xD;
      cause an imbalance in the hormones that control blood glucose.&#xD;
&#xD;
      Skipping breakfast can affect how well insulin works at lowering blood glucose at later meal&#xD;
      times. The impact of breakfast on glucose homeostasis is different from that of lunch and&#xD;
      dinner. This became evident when a group of researchers studied the effect of skipping&#xD;
      breakfast on hormone responses after subsequent isocaloric lunch and dinner in adults with&#xD;
      Type 2 diabetes. The study showed that in Type 2 diabetics, skipping breakfast leads to&#xD;
      increased post-prandial hyperglycemia and decreased glucagon-like peptide-1 (GLP-1) release,&#xD;
      impairing the insulin response to hyperglycemia. Plasma free fatty acids (FFA) levels were&#xD;
      found to be significantly higher after lunch and dinner when breakfast was omitted. It has&#xD;
      been shown that acute elevation of FFA induces hepatic insulin resistance and increased&#xD;
      hepatic glucose production in patients with Type 2 Diabetes Mellitus and in non-diabetic&#xD;
      controls. Impaired insulin secretion can predispose to conditions such as obesity, and other&#xD;
      diseases.&#xD;
&#xD;
      Skipping breakfast can also have a negative effect on children's ability to keep focus and&#xD;
      attention. The CTET is a tool that can be used to directly measure attention using an EEG and&#xD;
      is a highly sensitive measure of neural processing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 30, 2017</start_date>
  <completion_date type="Actual">January 1, 2019</completion_date>
  <primary_completion_date type="Actual">January 1, 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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The measurement of glucose will be euglycemic during the breakfast study visit</measure>
    <time_frame>0min to 420 min during both during the treatment and control visits over the one year study period. Each study visit will be conducted on 2 separate days with a washout period of at least 1 week in between the study visits for each patient</time_frame>
    <description>Area under the curve of glucose from time 0min to 420 min.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The measurement of C-peptide will be steady during the breakfast study visit</measure>
    <time_frame>0min to 420 min during both during the treatment and control visits over the one year study period. Each study visit will be conducted on 2 separate days with a washout period of at least 1 week in between the study visits for each patient</time_frame>
    <description>Area under the curve of C-peptide from time 0min to 420 min.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The measurement of insulin will be steady during the breakfast study visit</measure>
    <time_frame>0min to 420 min during both during the treatment and control visits over the one year study period. Each study visit will be conducted on 2 separate days with a washout period of at least 1 week in between the study visits for each patient</time_frame>
    <description>Area under the curve of insulin from time 0min to 420 min.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The measurement of free fatty acids will be steady during the breakfast study visit</measure>
    <time_frame>0min to 420 min during both during the treatment and control visits over the one year study period. Each study visit will be conducted on 2 separate days with a washout period of at least 1 week in between the study visits for each patient</time_frame>
    <description>Area under the curve of free fatty acids from time 0min to 420 min.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The measurement of glucagon-like peptide will be steady during the breakfast study visit</measure>
    <time_frame>0min to 420 min during both during the treatment and control visits over the one year study period. Each study visit will be conducted on 2 separate days with a washout period of at least 1 week in between the study visits for each patient</time_frame>
    <description>Area under the curve of glucagon- like peptide from time 0min to 420 min.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The measurement of glucagon will be steady during the breakfast study visit</measure>
    <time_frame>0min to 420 min during both during the treatment and control visits over the one year study period. Each study visit will be conducted on 2 separate days with a washout period of at least 1 week in between the study visits for each patient</time_frame>
    <description>Area under the curve of glucagon from time 0min to 420 min.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The measurement of CTET will be better during the breakfast study visit</measure>
    <time_frame>0min to 420 min during both during the treatment and control visits over the one year study period. Each study visit will be conducted on 2 separate days with a washout period of at least 1 week in between the study visits for each patient</time_frame>
    <description>Area under the curve of CTET from time 0min to 420 min.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Insulin Resistance</condition>
  <arm_group>
    <arm_group_label>Lean males</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is a randomized, two-period, cross over design with the intervention of consuming breakfast versus fasting for breakfast to study the effects on hormone responses and cognitive function using CTET in lean and obese male adolescents. These two study groups will be randomized to one of two orders:: (A,B) or (B,A) where A = Yes breakfast and B=No breakfast</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Obese males</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is a randomized, two-period, cross over design with the intervention of consuming breakfast versus fasting for breakfast to study the effects on hormone responses and cognitive function using CTET in lean and obese male adolescents. These two study groups will be randomized to one of two orders:: (A,B) or (B,A) where A = Yes breakfast and B=No breakfast</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>A= Yes Breakfast</intervention_name>
    <description>Study visit will include analysis of cognitive function (CTET), insulin, glucagon, C-peptide, free fatty acids, and GLP-1 when given breakfast and lunch</description>
    <arm_group_label>Lean males</arm_group_label>
    <arm_group_label>Obese males</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>B=No Breakfast</intervention_name>
    <description>Study visit will include analysis of cognitive function (CTET), insulin, glucagon, C-peptide, free fatty acids, and GLP-1 when breakfast is skipped and lunch is provided.</description>
    <arm_group_label>Lean males</arm_group_label>
    <arm_group_label>Obese males</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy males&#xD;
&#xD;
          2. No history of neurological or psychiatric illness, including major depressive disorder&#xD;
             and attention deficit disorder.&#xD;
&#xD;
          3. Normal or corrected vision using the Snellen chart&#xD;
&#xD;
          4. Normal hearing&#xD;
&#xD;
          5. BMI greater than or equal to 95th percentile according to the Center for Disease&#xD;
             Control and Prevention (CDC) growth charts&#xD;
&#xD;
          6. HbA1C less than or equal to 5.6%&#xD;
&#xD;
          7. Hemoglobin level of greater or equal to 12g/dL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of chronic illness and chronic use of medications that affect cognitive or&#xD;
             glucose metabolism&#xD;
&#xD;
          2. History of substance, nicotine or alcohol dependence as assessed by CRAFFT (CAR,&#xD;
             RELAX, ALONE, FORGET, FRIENDS, TROUBLE) questionnaire&#xD;
&#xD;
          3. History of eating disorder as assessed by the SCOFF questionnaire.&#xD;
&#xD;
          4. Developmental delay&#xD;
&#xD;
          5. Hearing and vision problems as assessed by the Snellen chart&#xD;
&#xD;
          6. Previous history of bariatric surgery&#xD;
&#xD;
          7. Currently taking supplements or medications indicated for weight loss&#xD;
&#xD;
          8. Previous history of head injury associated with loss of consciousness for several&#xD;
             minutes&#xD;
&#xD;
          9. History of Epilepsy&#xD;
&#xD;
         10. Allergy to any of the foods used for the test breakfasts&#xD;
&#xD;
        The inclusion and exclusion criteria for lean subjects will be identical to that of obese&#xD;
        subjects with the exception that the lean subjects will be less than or equal to the 85th&#xD;
        percentile for BMI, according to CDC growth charts.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lisa Underland, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Albert Einstein College of Medicine. Montefiore Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Montefiore Medical Center of Albert Einstein College of Medicine</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Jakubowicz D, Wainstein J, Ahren B, Landau Z, Bar-Dayan Y, Froy O. Fasting until noon triggers increased postprandial hyperglycemia and impaired insulin response after lunch and dinner in individuals with type 2 diabetes: a randomized clinical trial. Diabetes Care. 2015 Oct;38(10):1820-6. doi: 10.2337/dc15-0761. Epub 2015 Jul 28.</citation>
    <PMID>26220945</PMID>
  </reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 24, 2016</study_first_submitted>
  <study_first_submitted_qc>December 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>August 23, 2023</last_update_submitted>
  <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin Resistance</mesh_term>
  </condition_browse>
  <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/NCT03005951
org study id: 2015-5542
nct id: NCT03005951
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to see what effect skipping breakfast versus consuming breakfast
      has on cognitive performance and the hormones responsible for glucose homeostasis in lean and
      obese adolescent males. The subjects will be tested on their ability to maintain attention
      when given several tasks called continuous temporal expectancy tasks (CTET) and
      electrophysiological signals using electroencephalogram (EEG) will be monitored. These two
      study groups will be randomized to one of two orders: (A,B) or (B,A) where A = breakfast
      intervention and B = no breakfast. There will be a washout period of 7 days in between study
      visits.
Eating unhealthy foods and not exercising regularly contributes to obesity in children. Other
      unhealthy behaviors, such as skipping meals can also lead to obesity. Breakfast is known to
      be the most important meal of the day, yet many people skip breakfast. Skipping breakfast can
      cause an imbalance in the hormones that control blood glucose.

      Skipping breakfast can affect how well insulin works at lowering blood glucose at later meal
      times. The impact of breakfast on glucose homeostasis is different from that of lunch and
      dinner. This became evident when a group of researchers studied the effect of skipping
      breakfast on hormone responses after subsequent isocaloric lunch and dinner in adults with
      Type 2 diabetes. The study showed that in Type 2 diabetics, skipping breakfast leads to
      increased post-prandial hyperglycemia and decreased glucagon-like peptide-1 (GLP-1) release,
      impairing the insulin response to hyperglycemia. Plasma free fatty acids (FFA) levels were
      found to be significantly higher after lunch and dinner when breakfast was omitted. It has
      been shown that acute elevation of FFA induces hepatic insulin resistance and increased
      hepatic glucose production in patients with Type 2 Diabetes Mellitus and in non-diabetic
      controls. Impaired insulin secretion can predispose to conditions such as obesity, and other
      diseases.

      Skipping breakfast can also have a negative effect on children's ability to keep focus and
      attention. The CTET is a tool that can be used to directly measure attention using an EEG and
      is a highly sensitive measure of neural processing.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: The measurement of glucose will be euglycemic during the breakfast study visit
time frame: 0min to 420 min during both during the treatment and control visits over the one year study period. Each study visit will be conducted on 2 separate days with a washout period of at least 1 week in between the study visits for each patient
description: Area under the curve of glucose from time 0min to 420 min.
measure: The measurement of C-peptide will be steady during the breakfast study visit
time frame: 0min to 420 min during both during the treatment and control visits over the one year study period. Each study visit will be conducted on 2 separate days with a washout period of at least 1 week in between the study visits for each patient
description: Area under the curve of C-peptide from time 0min to 420 min.
measure: The measurement of insulin will be steady during the breakfast study visit
time frame: 0min to 420 min during both during the treatment and control visits over the one year study period. Each study visit will be conducted on 2 separate days with a washout period of at least 1 week in between the study visits for each patient
description: Area under the curve of insulin from time 0min to 420 min.
measure: The measurement of free fatty acids will be steady during the breakfast study visit
time frame: 0min to 420 min during both during the treatment and control visits over the one year study period. Each study visit will be conducted on 2 separate days with a washout period of at least 1 week in between the study visits for each patient
description: Area under the curve of free fatty acids from time 0min to 420 min.
measure: The measurement of glucagon-like peptide will be steady during the breakfast study visit
time frame: 0min to 420 min during both during the treatment and control visits over the one year study period. Each study visit will be conducted on 2 separate days with a washout period of at least 1 week in between the study visits for each patient
description: Area under the curve of glucagon- like peptide from time 0min to 420 min.
measure: The measurement of glucagon will be steady during the breakfast study visit
time frame: 0min to 420 min during both during the treatment and control visits over the one year study period. Each study visit will be conducted on 2 separate days with a washout period of at least 1 week in between the study visits for each patient
description: Area under the curve of glucagon from time 0min to 420 min.
measure: The measurement of CTET will be better during the breakfast study visit
time frame: 0min to 420 min during both during the treatment and control visits over the one year study period. Each study visit will be conducted on 2 separate days with a washout period of at least 1 week in between the study visits for each patient
description: Area under the curve of CTET from time 0min to 420 min.
arm group label: Lean males
arm group type: Experimental
description: This is a randomized, two-period, cross over design with the intervention of consuming breakfast versus fasting for breakfast to study the effects on hormone responses and cognitive function using CTET in lean and obese male adolescents. These two study groups will be randomized to one of two orders:: (A,B) or (B,A) where A = Yes breakfast and B=No breakfast
arm group label: Obese males
arm group type: Experimental
description: This is a randomized, two-period, cross over design with the intervention of consuming breakfast versus fasting for breakfast to study the effects on hormone responses and cognitive function using CTET in lean and obese male adolescents. These two study groups will be randomized to one of two orders:: (A,B) or (B,A) where A = Yes breakfast and B=No breakfast
intervention type: Other
intervention name: A= Yes Breakfast
description: Study visit will include analysis of cognitive function (CTET), insulin, glucagon, C-peptide, free fatty acids, and GLP-1 when given breakfast and lunch
arm group label: Lean males
arm group label: Obese males
intervention type: Other
intervention name: B=No Breakfast
description: Study visit will include analysis of cognitive function (CTET), insulin, glucagon, C-peptide, free fatty acids, and GLP-1 when breakfast is skipped and lunch is provided.
arm group label: Lean males
arm group label: Obese males
criteria: 
gender: Male
minimum age: 13 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lisa Underland, MD
role: Principal Investigator
affiliation: Albert Einstein College of Medicine. Montefiore Medical Center
facility: 
country: United States
citation: Jakubowicz D, Wainstein J, Ahren B, Landau Z, Bar-Dayan Y, Froy O. Fasting until noon triggers increased postprandial hyperglycemia and impaired insulin response after lunch and dinner in individuals with type 2 diabetes: a randomized clinical trial. Diabetes Care. 2015 Oct;38(10):1820-6. doi: 10.2337/dc15-0761. Epub 2015 Jul 28.
PMID: 26220945
responsible party type: Sponsor
mesh term: Insulin Resistance
sharing ipd: No