<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/NCT04409457</url>
  </required_header>
  <id_info>
    <org_study_id>GCO 19-1047</org_study_id>
    <secondary_id>K23MH118418</secondary_id>
    <nct_id>NCT04409457</nct_id>
  </id_info>
  <brief_title>Self-Control in Bulimia Nervosa</brief_title>
  <official_title>The Influences of Eating and Fasting on Inhibitory Control in Bulimia Nervosa: A Computational Neuroimaging Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Icahn School of Medicine at Mount Sinai</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>
      This study examines the influence of acute fasting and eating on self-control in adult&#xD;
      females with and without bulimia nervosa (BN). Specifically, the study team is investigating&#xD;
      whether differences in behavior and brain activation in response to computer tasks after&#xD;
      fasting and after eating a meal could help to explain the symptoms of bulimia nervosa. Data&#xD;
      will be collected using questionnaires and a technology called magnetic resonance imaging&#xD;
      (MRI).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Treatment-resistant binge eating and purging may be perpetuated by self-control deficits&#xD;
      linked to reduced activation in frontostriatal circuits. To date, however, neurocognitive&#xD;
      studies of BN have not assessed the dynamic computational processes underlying inhibition or&#xD;
      considered the fact that individuals with BN oscillate between two extremes-under-controlled&#xD;
      and over-controlled intake. The proposed study combines neuroimaging with computational&#xD;
      modeling to investigate the influences of acute fasting and eating (i.e., metabolic states)&#xD;
      on how the brains of women with bulimia nervosa (BN) adaptively prepare for and exert&#xD;
      inhibitory control. More specifically, the study has the following main objectives: 1) To&#xD;
      determine whether eating and fasting affect adaptive inhibitory control and related&#xD;
      frontostriatal activation abnormally in BN; 2) To identify associations of BN severity with&#xD;
      state-specific frontostriatal activation and behavior.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 18, 2020</start_date>
  <completion_date type="Anticipated">July 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2024</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>Two participant groups (one with and one without bulimia nervosa) will be scanned using MRI after they have fasted and after they have consumed a standardized meal. The order of these two scans will be counterbalanced across groups.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>P(stop) at fasting state</measure>
    <time_frame>at 16 hours after fast</time_frame>
    <description>Frontostriatal activation associated with the predicted likelihood that upcoming inhibition is needed (P(stop))</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prediction errors at fasting state</measure>
    <time_frame>at 16 hours after fast</time_frame>
    <description>Frontostriatal activation associated with: inhibitory control prediction errors (signed and unsigned)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Successful inhibition at fasting state</measure>
    <time_frame>at 16 hours after fast</time_frame>
    <description>Frontostriatal activation associated with successful inhibition</description>
  </primary_outcome>
  <primary_outcome>
    <measure>P(stop) at fed state</measure>
    <time_frame>at 30 minutes after a standardized meal</time_frame>
    <description>Frontostriatal activation associated with the predicted likelihood that upcoming inhibition is needed (P(stop))</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prediction errors at fed state</measure>
    <time_frame>at 30 minutes after a standardized meal</time_frame>
    <description>Frontostriatal activation associated with inhibitory control prediction errors (signed and unsigned)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Successful inhibition at fed state</measure>
    <time_frame>at 30 minutes after a standardized meal</time_frame>
    <description>Frontostriatal activation associated with successful inhibition</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stop Signal Reaction Time (SSRT) at fasting state</measure>
    <time_frame>at 16 hours after fast</time_frame>
    <description>Behavioral performance on the stop signal task, as measured by stop signal reaction time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stop Signal Reaction Time (SSRT) at fed state</measure>
    <time_frame>at 30 minutes after a standardized meal</time_frame>
    <description>Behavioral performance on the stop signal task, as measured by stop signal reaction time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stop Signal Task Performance at fasting state</measure>
    <time_frame>at 16 hours after fast</time_frame>
    <description>Percent correct responses to stop trial on Stop Signal Task Performance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stop Signal Task Performance at fed state</measure>
    <time_frame>at 30 minutes after a standardized meal</time_frame>
    <description>Percent correct responses to stop trial on Stop Signal Task Performance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Eating Disorder Symptom Episodes</measure>
    <time_frame>Baseline (At study screening)</time_frame>
    <description>The frequency of binge eating episodes, self-induced vomiting episodes, and fasting episodes as assessed by the Eating Disorder Examination (EDE). Frequency of episodes assessed with no minimum or maximum limit.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Bulimia Nervosa</condition>
  <arm_group>
    <arm_group_label>Participants with Bulimia Nervosa</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants are randomly assigned (in even numbers across the two groups) to scan order:&#xD;
A. These participants are first scanned after 16 hours of fasting on one day, and are next scanned after a standardized meal on a second day.&#xD;
B. These participants are first scanned after a standardized meal on one day, and are next scanned after 16 hours of fasting on a second day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Participants without Bulimia Nervosa</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants are randomly assigned (in even numbers across the two groups) to scan order:&#xD;
A. These participants are first scanned after 16 hours of fasting on one day, and are next scanned after a standardized meal on a second day.&#xD;
B. These participants are first scanned after a standardized meal on one day, and are next scanned after 16 hours of fasting on a second day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>fasting state</intervention_name>
    <description>16 hours of fasting</description>
    <arm_group_label>Participants with Bulimia Nervosa</arm_group_label>
    <arm_group_label>Participants without Bulimia Nervosa</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>fed state</intervention_name>
    <description>fed a standardized meal</description>
    <arm_group_label>Participants with Bulimia Nervosa</arm_group_label>
    <arm_group_label>Participants without Bulimia Nervosa</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>magnetic resonance imaging</intervention_name>
    <description>neuroimaging with computational modeling</description>
    <arm_group_label>Participants with Bulimia Nervosa</arm_group_label>
    <arm_group_label>Participants without Bulimia Nervosa</arm_group_label>
    <other_name>MRI</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Aged 18 to 35 years&#xD;
&#xD;
          -  Currently between 85 and 130% of the expected weight for height&#xD;
&#xD;
          -  Right-handed&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
        Additional Inclusion Criteria for Women with Bulimia Nervosa:&#xD;
&#xD;
        ° Meet DSM-5 criteria for bulimia nervosa&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical instability&#xD;
&#xD;
          -  Ongoing medical treatment, medical condition, or psychiatric disorder that may&#xD;
             interfere with study variables or participation&#xD;
&#xD;
          -  Shift work&#xD;
&#xD;
          -  Pregnancy, planned pregnancy, or lactation during the study period&#xD;
&#xD;
          -  Allergy to any of the ingredients in or unwillingness to consume the standardized meal&#xD;
             or unwillingness to drink water during the fasting period&#xD;
&#xD;
          -  Any contraindication for fMRI&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>The prevalence of bulimia nervosa is substantially greater in women than in men. Moreover, prior research suggest that men and women show different neural response patterns during the engagement of inhibitory control, and that satiety differentially impacts the neural function of men and women.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laura A Berner, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Maia Chester, BA</last_name>
    <phone>212-659-8799</phone>
    <email>maia.chester@mssm.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Laura A Berner, PhD</last_name>
    <phone>212-659-8799</phone>
    <email>laura.berner@mssm.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Laura A Berner, Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>October 24, 2022</last_update_submitted>
  <last_update_submitted_qc>October 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Icahn School of Medicine at Mount Sinai</investigator_affiliation>
    <investigator_full_name>Laura Berner</investigator_full_name>
    <investigator_title>Assistant Professor of Psychiatry</investigator_title>
  </responsible_party>
  <keyword>bulimia nervosa</keyword>
  <keyword>binge eating</keyword>
  <keyword>purging</keyword>
  <keyword>fasting</keyword>
  <keyword>eating disorder</keyword>
  <keyword>control</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bulimia</mesh_term>
    <mesh_term>Bulimia Nervosa</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).</ipd_description>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Beginning 24 months following peer-reviewed article publication</ipd_time_frame>
    <ipd_access_criteria>Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.</ipd_access_criteria>
  </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/NCT04409457
org study id: GCO 19-1047
secondary id: K23MH118418
nct id: NCT04409457
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study examines the influence of acute fasting and eating on self-control in adult
      females with and without bulimia nervosa (BN). Specifically, the study team is investigating
      whether differences in behavior and brain activation in response to computer tasks after
      fasting and after eating a meal could help to explain the symptoms of bulimia nervosa. Data
      will be collected using questionnaires and a technology called magnetic resonance imaging
      (MRI).
Treatment-resistant binge eating and purging may be perpetuated by self-control deficits
      linked to reduced activation in frontostriatal circuits. To date, however, neurocognitive
      studies of BN have not assessed the dynamic computational processes underlying inhibition or
      considered the fact that individuals with BN oscillate between two extremes-under-controlled
      and over-controlled intake. The proposed study combines neuroimaging with computational
      modeling to investigate the influences of acute fasting and eating (i.e., metabolic states)
      on how the brains of women with bulimia nervosa (BN) adaptively prepare for and exert
      inhibitory control. More specifically, the study has the following main objectives: 1) To
      determine whether eating and fasting affect adaptive inhibitory control and related
      frontostriatal activation abnormally in BN; 2) To identify associations of BN severity with
      state-specific frontostriatal activation and behavior.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Two participant groups (one with and one without bulimia nervosa) will be scanned using MRI after they have fasted and after they have consumed a standardized meal. The order of these two scans will be counterbalanced across groups.
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: P(stop) at fasting state
time frame: at 16 hours after fast
description: Frontostriatal activation associated with the predicted likelihood that upcoming inhibition is needed (P(stop))
measure: Prediction errors at fasting state
time frame: at 16 hours after fast
description: Frontostriatal activation associated with: inhibitory control prediction errors (signed and unsigned)
measure: Successful inhibition at fasting state
time frame: at 16 hours after fast
description: Frontostriatal activation associated with successful inhibition
measure: P(stop) at fed state
time frame: at 30 minutes after a standardized meal
description: Frontostriatal activation associated with the predicted likelihood that upcoming inhibition is needed (P(stop))
measure: Prediction errors at fed state
time frame: at 30 minutes after a standardized meal
description: Frontostriatal activation associated with inhibitory control prediction errors (signed and unsigned)
measure: Successful inhibition at fed state
time frame: at 30 minutes after a standardized meal
description: Frontostriatal activation associated with successful inhibition
measure: Stop Signal Reaction Time (SSRT) at fasting state
time frame: at 16 hours after fast
description: Behavioral performance on the stop signal task, as measured by stop signal reaction time
measure: Stop Signal Reaction Time (SSRT) at fed state
time frame: at 30 minutes after a standardized meal
description: Behavioral performance on the stop signal task, as measured by stop signal reaction time
measure: Stop Signal Task Performance at fasting state
time frame: at 16 hours after fast
description: Percent correct responses to stop trial on Stop Signal Task Performance
measure: Stop Signal Task Performance at fed state
time frame: at 30 minutes after a standardized meal
description: Percent correct responses to stop trial on Stop Signal Task Performance
measure: Frequency of Eating Disorder Symptom Episodes
time frame: Baseline (At study screening)
description: The frequency of binge eating episodes, self-induced vomiting episodes, and fasting episodes as assessed by the Eating Disorder Examination (EDE). Frequency of episodes assessed with no minimum or maximum limit.
arm group label: Participants with Bulimia Nervosa
arm group type: Other
description: Participants are randomly assigned (in even numbers across the two groups) to scan order:
A. These participants are first scanned after 16 hours of fasting on one day, and are next scanned after a standardized meal on a second day.
B. These participants are first scanned after a standardized meal on one day, and are next scanned after 16 hours of fasting on a second day.
arm group label: Participants without Bulimia Nervosa
arm group type: Other
description: Participants are randomly assigned (in even numbers across the two groups) to scan order:
A. These participants are first scanned after 16 hours of fasting on one day, and are next scanned after a standardized meal on a second day.
B. These participants are first scanned after a standardized meal on one day, and are next scanned after 16 hours of fasting on a second day.
intervention type: Other
intervention name: fasting state
description: 16 hours of fasting
arm group label: Participants with Bulimia Nervosa
arm group label: Participants without Bulimia Nervosa
intervention type: Other
intervention name: fed state
description: fed a standardized meal
arm group label: Participants with Bulimia Nervosa
arm group label: Participants without Bulimia Nervosa
intervention type: Other
intervention name: magnetic resonance imaging
description: neuroimaging with computational modeling
arm group label: Participants with Bulimia Nervosa
arm group label: Participants without Bulimia Nervosa
other name: MRI
criteria: 
gender: Female
gender based: Yes
gender description: The prevalence of bulimia nervosa is substantially greater in women than in men. Moreover, prior research suggest that men and women show different neural response patterns during the engagement of inhibitory control, and that satiety differentially impacts the neural function of men and women.
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Laura A Berner, PhD
role: Principal Investigator
affiliation: Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai
last name: Maia Chester, BA
phone: 212-659-8799
email: maia.chester@mssm.edu
last name: Laura A Berner, PhD
phone: 212-659-8799
email: laura.berner@mssm.edu
facility: 
status: Recruiting
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Icahn School of Medicine at Mount Sinai
investigator full name: Laura Berner
investigator title: Assistant Professor of Psychiatry
mesh term: Bulimia
mesh term: Bulimia Nervosa
sharing ipd: Yes
ipd description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Beginning 24 months following peer-reviewed article publication
ipd access criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.