<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/NCT03800732</url>
  </required_header>
  <id_info>
    <org_study_id>86382218.6.0000.5152</org_study_id>
    <nct_id>NCT03800732</nct_id>
  </id_info>
  <brief_title>The Influence of Nocturnal Food Intake in Eating Behavior of Night Workers</brief_title>
  <official_title>The Influence of Nocturnal Food Intake in Eating Behavior of Night Workers: Randomized Cross-over Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Uberlandia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Uberlandia</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>
      This study aimed to verify the influence of night work and food intake during the night shift&#xD;
      on the eating behavior of fixed night workers the next day.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Night work causes restriction of sleep time and circadian misalignment and, therefore, have&#xD;
      been associated with nutritional and metabolic impairments. The objective of the present&#xD;
      study is to verify the influence of night work and food intake in this period on the behavior&#xD;
      of the following day. The workers selected by criteria and inclusion and exclusion will be&#xD;
      evaluated at the baseline: anthropometric parameters, food consumption and perception,&#xD;
      duration of food consumption, sleep habits and chronobiological pattern (sleep monitoring by&#xD;
      actigraphy, chronotype, social jet lag), parameters biochemical (blood count, lipidogram,&#xD;
      C-reactive protein, cortisol, glucose, insulin).Subsequently, 30 workers will integrate a&#xD;
      randomized and controlled crossover clinical study with three randomly established&#xD;
      interventions: (1) two nights of work without meals during the shift; (2) two nights of work&#xD;
      with a meal during the shift; (3) two nights sleep. Participants will go to the laboratory&#xD;
      the morning after the second night of each condition to offer a test meal ad libitum, which&#xD;
      will consist of foods of various compositions and food groups. Preprandial metabolic&#xD;
      assessments will be conducted (ghrelin, GLP-1 - glucagon-like peptide 1, PYY-peptide YY). The&#xD;
      following postprandial evaluations will be carried out and in the 24 hours following the&#xD;
      experiment: food choices (record of all foods) and food perceptions (hunger, appetite,&#xD;
      satiety and eating). It is expected to determine how nocturnal versus nocturnal work, and&#xD;
      nocturnal fasting versus nocturnal fasting affect the next day's food choices.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">July 1, 2020</completion_date>
  <primary_completion_date type="Actual">September 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>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Preprandial metabolic</measure>
    <time_frame>6 months</time_frame>
    <description>Ghrelin, GLP-1 - glucagon-like peptide 1, PYY-peptide YY</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of food perceptions</measure>
    <time_frame>6 months</time_frame>
    <description>To evaluate appetite, satiety and postprandial satisfaction, a visual analogue scale was applied before and after consumption of the proposed meal, with the questions, &quot;How much hunger did you have before the meal?&quot;; &quot;After the meal, how did you feel?&quot;; &quot;How much did you like the meal?&quot;, Signaling all responses on a 0 to 10 cm scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Food behavior</measure>
    <time_frame>6 months</time_frame>
    <description>Record of food consumption of the meals / snacks held following the test meal.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Shift Work Type Circadian Rhythm Sleep Disorder</condition>
  <arm_group>
    <arm_group_label>Night workers.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Night workers of the military police of Minas Gerais, Uberlândia, who will participate in the three interventions of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>With Meal during night work</intervention_name>
    <description>Two nights of work with a meal during the shift and after will go to the laboratory the morning for eating a test meal ad libitum, which will consist of foods of various compositions and food groups. Preprandial metabolic assessments will be conducted (ghrelin, GLP-1 - glucagon-like peptide 1, PYY-peptide YY). The following postprandial evaluations will be carried out and in the 24 hours following the experiment: food choices (record of all foods) and food perceptions (hunger, appetite, satiety and eating).</description>
    <arm_group_label>Night workers.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Without Meal during night work</intervention_name>
    <description>Two nights of work without a meal during the shift and after will go to the laboratory the morning for eating a test meal ad libitum, which will consist of foods of various compositions and food groups. Preprandial metabolic assessments will be conducted (ghrelin, GLP-1 - glucagon-like peptide 1, PYY-peptide YY). The following postprandial evaluations will be carried out and in the 24 hours following the experiment: food choices (record of all foods) and food perceptions (hunger, appetite, satiety and eating).</description>
    <arm_group_label>Night workers.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sleep night</intervention_name>
    <description>Two sleep nights and after will go to the laboratory the morning for eating a test meal ad libitum, which will consist of foods of various compositions and food groups. Preprandial metabolic assessments will be conducted (ghrelin, GLP-1 - glucagon-like peptide 1, PYY-peptide YY). The following postprandial evaluations will be carried out and in the 24 hours following the experiment: food choices (record of all foods) and food perceptions (hunger, appetite, satiety and eating).</description>
    <arm_group_label>Night workers.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Agree to participate in the study and sign the Informed Consent Form (EHIC).&#xD;
&#xD;
          -  No significant changes in body mass in the last 6 months.&#xD;
&#xD;
          -  With stable food and sleep routine in the last two months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Failure to provide the information or material necessary for the development of the&#xD;
             study.&#xD;
&#xD;
          -  Report of chronic non-communicable diseases.&#xD;
&#xD;
          -  Report of diagnosed and untreated psychiatric disorders.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cibele Aparecida Crispim</name>
      <address>
        <city>Uberlândia</city>
        <state>Minas Gerais</state>
        <zip>38.405-320</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>February 10, 2022</last_update_submitted>
  <last_update_submitted_qc>February 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Uberlandia</investigator_affiliation>
    <investigator_full_name>Cibele Aparecida Crispim</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Wake Disorders</mesh_term>
    <mesh_term>Sleep Disorders, Circadian Rhythm</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>February 11, 2022</submitted>
    <submission_canceled>February 23, 2022</submission_canceled>
    <submitted>February 23, 2022</submitted>
    <returned>May 12, 2022</returned>
  </pending_results>
  <!-- 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/NCT03800732
org study id: 86382218.6.0000.5152
nct id: NCT03800732
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aimed to verify the influence of night work and food intake during the night shift
      on the eating behavior of fixed night workers the next day.
Night work causes restriction of sleep time and circadian misalignment and, therefore, have
      been associated with nutritional and metabolic impairments. The objective of the present
      study is to verify the influence of night work and food intake in this period on the behavior
      of the following day. The workers selected by criteria and inclusion and exclusion will be
      evaluated at the baseline: anthropometric parameters, food consumption and perception,
      duration of food consumption, sleep habits and chronobiological pattern (sleep monitoring by
      actigraphy, chronotype, social jet lag), parameters biochemical (blood count, lipidogram,
      C-reactive protein, cortisol, glucose, insulin).Subsequently, 30 workers will integrate a
      randomized and controlled crossover clinical study with three randomly established
      interventions: (1) two nights of work without meals during the shift; (2) two nights of work
      with a meal during the shift; (3) two nights sleep. Participants will go to the laboratory
      the morning after the second night of each condition to offer a test meal ad libitum, which
      will consist of foods of various compositions and food groups. Preprandial metabolic
      assessments will be conducted (ghrelin, GLP-1 - glucagon-like peptide 1, PYY-peptide YY). The
      following postprandial evaluations will be carried out and in the 24 hours following the
      experiment: food choices (record of all foods) and food perceptions (hunger, appetite,
      satiety and eating). It is expected to determine how nocturnal versus nocturnal work, and
      nocturnal fasting versus nocturnal fasting affect the next day's food choices.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Preprandial metabolic
time frame: 6 months
description: Ghrelin, GLP-1 - glucagon-like peptide 1, PYY-peptide YY
measure: Change of food perceptions
time frame: 6 months
description: To evaluate appetite, satiety and postprandial satisfaction, a visual analogue scale was applied before and after consumption of the proposed meal, with the questions, "How much hunger did you have before the meal?"; "After the meal, how did you feel?"; "How much did you like the meal?", Signaling all responses on a 0 to 10 cm scale.
measure: Food behavior
time frame: 6 months
description: Record of food consumption of the meals / snacks held following the test meal.
arm group label: Night workers.
arm group type: Experimental
description: Night workers of the military police of Minas Gerais, Uberlândia, who will participate in the three interventions of the study.
intervention type: Other
intervention name: With Meal during night work
description: Two nights of work with a meal during the shift and after will go to the laboratory the morning for eating a test meal ad libitum, which will consist of foods of various compositions and food groups. Preprandial metabolic assessments will be conducted (ghrelin, GLP-1 - glucagon-like peptide 1, PYY-peptide YY). The following postprandial evaluations will be carried out and in the 24 hours following the experiment: food choices (record of all foods) and food perceptions (hunger, appetite, satiety and eating).
arm group label: Night workers.
intervention type: Other
intervention name: Without Meal during night work
description: Two nights of work without a meal during the shift and after will go to the laboratory the morning for eating a test meal ad libitum, which will consist of foods of various compositions and food groups. Preprandial metabolic assessments will be conducted (ghrelin, GLP-1 - glucagon-like peptide 1, PYY-peptide YY). The following postprandial evaluations will be carried out and in the 24 hours following the experiment: food choices (record of all foods) and food perceptions (hunger, appetite, satiety and eating).
arm group label: Night workers.
intervention type: Other
intervention name: Sleep night
description: Two sleep nights and after will go to the laboratory the morning for eating a test meal ad libitum, which will consist of foods of various compositions and food groups. Preprandial metabolic assessments will be conducted (ghrelin, GLP-1 - glucagon-like peptide 1, PYY-peptide YY). The following postprandial evaluations will be carried out and in the 24 hours following the experiment: food choices (record of all foods) and food perceptions (hunger, appetite, satiety and eating).
arm group label: Night workers.
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of Uberlandia
investigator full name: Cibele Aparecida Crispim
investigator title: Principal investigator
mesh term: Sleep Wake Disorders
mesh term: Sleep Disorders, Circadian Rhythm
sharing ipd: Undecided
submitted: February 11, 2022
submission canceled: February 23, 2022
submitted: February 23, 2022
returned: May 12, 2022