<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/NCT03779321</url>
  </required_header>
  <id_info>
    <org_study_id>NUT.AO.20</org_study_id>
    <nct_id>NCT03779321</nct_id>
  </id_info>
  <brief_title>Effect of Food Acceptability on Appetite Hormones' Response in Normal Weight vs. Obese Male Subjects</brief_title>
  <official_title>Effect of Food Acceptability on Appetite Hormones' Response in Normal Weight vs. Obese Male Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>American University of Beirut Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>American University of Beirut Medical Center</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>
      Male subjects with specific body characteristics were recruited for the study. Subjects did&#xD;
      an acceptability test on custard and completed a screening questionnaire. Around 30 subjects&#xD;
      (15 with a normal BMI and 15 obese) continued the study. At each test day, fasting blood&#xD;
      samples were withdrawn by a registered nurse under sterile conditions. This procedure was&#xD;
      followed by ingestion of one of the two meals within a period of 10-15 minutes. Blood samples&#xD;
      of 5 ml were collected at fasting and after ingestion of meals. At the end, subjects were&#xD;
      given ad lib access to cheese pizza to assess energy intake after the custard preload. Blood&#xD;
      analysis for GLP-1, ghrelin, insulin and glucose levels were performed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Male subjects were recruited for the study based on the following criteria: age between 18&#xD;
      and 50, body mass index normal or obese, non-smokers, non-alcoholic, and do not take&#xD;
      medications. Subjects did an acceptability test on custard and completed a screening&#xD;
      questionnaire. Around 30 subjects (15 with a normal BMI and 15 obese) continued the study.&#xD;
      Subjects were randomly assigned to one of two meals. Each of the two meals was ingested after&#xD;
      a 3-day adaptation period. The meals had similar macronutrient composition and provided&#xD;
      energy equivalent to 30% of the subjects' resting energy expenditure. At each test day,&#xD;
      fasting blood samples were withdrawn by a registered nurse under sterile conditions. This&#xD;
      procedure was followed by ingestion of one of the two meals within a period of 10-15 minutes.&#xD;
      Blood samples of 5 ml were collected at fasting and after ingestion of meals at 15, 30, 60,&#xD;
      120, 180 and 240 minutes. At the end, subjects were given ad lib access to cheese pizza to&#xD;
      assess energy intake after the custard preload. Blood analysis for GLP-1, ghrelin, insulin&#xD;
      and glucose levels were performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2016</start_date>
  <completion_date type="Actual">September 30, 2017</completion_date>
  <primary_completion_date type="Actual">July 1, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Food acceptability</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Food acceptability on a 9 point hedonic scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ghrelin</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Ghrelin levels measured with Enzyme-linked immunosorbent assay (ELISA) kit</description>
  </primary_outcome>
  <primary_outcome>
    <measure>GLP-1</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>GLP-1 levels measured with Enzyme-linked immunosorbent assay (ELISA) kit</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Insulin</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Insulin levels measured with Enzyme-linked immunosorbent assay (ELISA) kit</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glucose</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Glucose levels measured using VITROS ECiQ Immunodiagnostic System</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Appetite</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Appetite score on the visual analogue scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Energy intake at the next meal</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Measuring quantity of cheese pizza consumed</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Eating Behavior</condition>
  <arm_group>
    <arm_group_label>Lean panelists</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Lean panelists or normal weight panelists with a BMI between 18.5 and 24.9 Acceptability was assessed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Obese panelists</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Obese panelists with a BMI between 25 and 29.9 Acceptability was assessed</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Acceptability</intervention_name>
    <description>Food samples two formulations (low and high acceptability levels) of custard were used as experimental meals</description>
    <arm_group_label>Lean panelists</arm_group_label>
    <arm_group_label>Obese panelists</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gender: Male&#xD;
&#xD;
          -  Age: 18-50 years&#xD;
&#xD;
          -  Body Mass Index (BMI): 18.5-24.9 kg/m2 or 30-39.9 kg/m2&#xD;
&#xD;
          -  Stable body weight for at least three months before the study with the absence of any&#xD;
             form of dieting, food restriction or other abnormal eating behaviors (to minimize the&#xD;
             effect of weight change on ghrelin and GLP-1 statuses)&#xD;
&#xD;
          -  Agreement on the acceptability levels of the two versions (high and low acceptability)&#xD;
             of custard&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Substance abuse such as alcohol or drugs&#xD;
&#xD;
          -  Medical or psychological illness&#xD;
&#xD;
          -  Previous gastrointestinal surgery&#xD;
&#xD;
          -  History of weight fluctuation (weight loss of greater than 5% within the past 3&#xD;
             months)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 19, 2018</last_update_submitted>
  <last_update_submitted_qc>December 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>American University of Beirut Medical Center</investigator_affiliation>
    <investigator_full_name>Ammar Olabi</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>food, acceptability, appetite, hormones, ghrelin, GLP-1</keyword>
  <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/NCT03779321
org study id: NUT.AO.20
nct id: NCT03779321
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Male subjects with specific body characteristics were recruited for the study. Subjects did
      an acceptability test on custard and completed a screening questionnaire. Around 30 subjects
      (15 with a normal BMI and 15 obese) continued the study. At each test day, fasting blood
      samples were withdrawn by a registered nurse under sterile conditions. This procedure was
      followed by ingestion of one of the two meals within a period of 10-15 minutes. Blood samples
      of 5 ml were collected at fasting and after ingestion of meals. At the end, subjects were
      given ad lib access to cheese pizza to assess energy intake after the custard preload. Blood
      analysis for GLP-1, ghrelin, insulin and glucose levels were performed.
Male subjects were recruited for the study based on the following criteria: age between 18
      and 50, body mass index normal or obese, non-smokers, non-alcoholic, and do not take
      medications. Subjects did an acceptability test on custard and completed a screening
      questionnaire. Around 30 subjects (15 with a normal BMI and 15 obese) continued the study.
      Subjects were randomly assigned to one of two meals. Each of the two meals was ingested after
      a 3-day adaptation period. The meals had similar macronutrient composition and provided
      energy equivalent to 30% of the subjects' resting energy expenditure. At each test day,
      fasting blood samples were withdrawn by a registered nurse under sterile conditions. This
      procedure was followed by ingestion of one of the two meals within a period of 10-15 minutes.
      Blood samples of 5 ml were collected at fasting and after ingestion of meals at 15, 30, 60,
      120, 180 and 240 minutes. At the end, subjects were given ad lib access to cheese pizza to
      assess energy intake after the custard preload. Blood analysis for GLP-1, ghrelin, insulin
      and glucose levels were performed.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Food acceptability
time frame: Through study completion, an average of 1 year
description: Food acceptability on a 9 point hedonic scale
measure: Ghrelin
time frame: Through study completion, an average of 1 year
description: Ghrelin levels measured with Enzyme-linked immunosorbent assay (ELISA) kit
measure: GLP-1
time frame: Through study completion, an average of 1 year
description: GLP-1 levels measured with Enzyme-linked immunosorbent assay (ELISA) kit
measure: Insulin
time frame: Through study completion, an average of 1 year
description: Insulin levels measured with Enzyme-linked immunosorbent assay (ELISA) kit
measure: Glucose
time frame: Through study completion, an average of 1 year
description: Glucose levels measured using VITROS ECiQ Immunodiagnostic System
measure: Appetite
time frame: Through study completion, an average of 1 year
description: Appetite score on the visual analogue scale
measure: Energy intake at the next meal
time frame: Through study completion, an average of 1 year
description: Measuring quantity of cheese pizza consumed
arm group label: Lean panelists
arm group type: Other
description: Lean panelists or normal weight panelists with a BMI between 18.5 and 24.9 Acceptability was assessed
arm group label: Obese panelists
arm group type: Other
description: Obese panelists with a BMI between 25 and 29.9 Acceptability was assessed
intervention type: Other
intervention name: Acceptability
description: Food samples two formulations (low and high acceptability levels) of custard were used as experimental meals
arm group label: Lean panelists
arm group label: Obese panelists
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: American University of Beirut Medical Center
investigator full name: Ammar Olabi
investigator title: Professor
sharing ipd: No