xml: <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/NCT06013592</url>
    </required_header>
    <id_info>
      <org_study_id>23HH8298</org_study_id>
      <nct_id>NCT06013592</nct_id>
    </id_info>
    <brief_title>Gut Hormone LEAP2 in Metabolism and Eating Behaviour: Fixed Meal Testing</brief_title>
    <acronym>LEAP2-meal</acronym>
    <official_title>Gut Hormone LEAP2 in Metabolism and Eating Behaviour: Fixed Meal Testing</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Imperial College London</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Imperial College London</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>
        The goal of this interventional study is to measure the blood levels of the gut hormones&#xD;
        LEAP2 and acyl ghrelin (AG), appetite and food intake after consuming liquid meals of&#xD;
        different caloric sizes, in healthy adults with and without obesity.&#xD;
  &#xD;
        AG is a stomach-derived homone that increases appetite, and LEAP2 a liver-gut derived hormone&#xD;
        that decreases appetite, which interferes the action of AG ant its receptor in the brain&#xD;
        called the growth hormone secretagogue receptor (GHSR). Blood levels of AG and LEAP2 change&#xD;
        in opposite directions after food intake (AG decreasing, LEAP2 increasing). AG is formed from&#xD;
        an inactive version of hormone called desacyl ghrelin (DAG). Previous studies have shown that&#xD;
        greater food intake leads to a greater decrease in blood levels of total ghrelin (AG + DAG),&#xD;
        but this has not been studied for changes in blood AG or LEAP2 after eating. Blood levels of&#xD;
        AG and total ghrelin when fasted and after food intake are lower, while blood levels of LEAP2&#xD;
        are higher, in adults with than those without obesity.&#xD;
  &#xD;
        The main study questions are:&#xD;
  &#xD;
          1. Are there greater increases in blood levels of LEAP2 and greater decreases in blood&#xD;
             levels of AG after consuming larger meals (by amount of calories they contain)?&#xD;
  &#xD;
          2. Are greater decreases in appetite after connsuming larger meals related to greater&#xD;
             increases in blood levels of LEAP2 and greater decreases in blood levels of AG?&#xD;
  &#xD;
          3. Are greater decreases in food intake at a buffet lunch after consuming larger meals&#xD;
             eaten a few hours previously related to greater increases in blood levels of LEAP2 and&#xD;
             greater decreases in blood levels of AG?&#xD;
  &#xD;
          4. Do the above findings differ between adults without obesity and with obesity?&#xD;
  &#xD;
        Healthy adults (without and with obesity) will consume liquid meals containing different&#xD;
        amounts of calories (0, 600, 1200, 1800 kcal, of identical total volume) after an overnight&#xD;
        fast and have measurements of blood LEAP2 and AG and appetite ratings from 0 to 180 min, and&#xD;
        have food intake at a buffet lunch measured at 180 mins.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 29, 2023</start_date>
    <completion_date type="Anticipated">August 2025</completion_date>
    <primary_completion_date type="Anticipated">August 2025</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>within participant</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>single-blinded, randomized order</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Post-prandial plasma concentration acyl ghrelin</measure>
      <time_frame>0, 30, 60, 120, 180 minutes</time_frame>
      <description>Incremental area under curve (iAUC 0-180 minutes)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Post-prandial plasma concentration LEAP2</measure>
      <time_frame>0, 30, 60, 120, 180 minutes</time_frame>
      <description>Incremental area under curve (iAUC 0-180 minutes)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>VAS ratings of appetite</measure>
      <time_frame>0, 30, 60, 120, 180 minutes</time_frame>
      <description>Incremental area under curve (iAUC 0-180 minutes)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ad libitum food intake</measure>
      <time_frame>180 minutes</time_frame>
      <description>Total kilocalories adjusted for estimated percentage of resting energy expenditure</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Eating Behavior</condition>
    <condition>Obesity</condition>
    <condition>Appetitive Behavior</condition>
    <arm_group>
      <arm_group_label>Healthy adults without obesity</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Liquid meals with different caloric sizes (0-1800 kcal)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy adults with obesity</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Liquid meals with different caloric sizes (0-1800 kcal)</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>0 kcal liquid</intervention_name>
      <description>Flavoured water</description>
      <arm_group_label>Healthy adults with obesity</arm_group_label>
      <arm_group_label>Healthy adults without obesity</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>600 kcal liquid meal</intervention_name>
      <description>Fortisip Compact Vanilla</description>
      <arm_group_label>Healthy adults with obesity</arm_group_label>
      <arm_group_label>Healthy adults without obesity</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>1200 kcal liquid meal</intervention_name>
      <description>Fortisip Compact Vanilla</description>
      <arm_group_label>Healthy adults with obesity</arm_group_label>
      <arm_group_label>Healthy adults without obesity</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>1800 kcal liquid meal</intervention_name>
      <description>Fortisip Compact Vanilla</description>
      <arm_group_label>Healthy adults with obesity</arm_group_label>
      <arm_group_label>Healthy adults without obesity</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female between the ages of 18 and 60 years;&#xD;
  &#xD;
            -  Without obesity with body mass index (BMI) 18.0-29.9 kg/m2 or with obesity with BMI&#xD;
               30.0-50.0 kg/m2;&#xD;
  &#xD;
            -  Healthy as determined by medical history and vital signs;&#xD;
  &#xD;
            -  Capable of giving written informed consent, which includes compliance with the&#xD;
               requirements and restrictions listed in the consent form;&#xD;
  &#xD;
            -  Participant is able to read, comprehend and record information written in English.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of, or current abuse or dependence on alcohol or drugs;&#xD;
  &#xD;
            -  Current smoker or less than 2 years since quitting (cigarette, cigars, e-cigarettes)&#xD;
               or use of nicotine replacement therapy;&#xD;
  &#xD;
            -  Significant current or past medical or psychiatric history that, in the opinion of the&#xD;
               investigators, contraindicates their participation;&#xD;
  &#xD;
            -  History of type 1 or type 2 diabetes mellitus;&#xD;
  &#xD;
            -  History of ischaemic heart disease, heart failure, cardiac arrhythmia, peripheral&#xD;
               vascular, cerebrovascular disease or uncontrolled hypertension;&#xD;
  &#xD;
            -  Current diagnosis of anaemia or iron deficiency;&#xD;
  &#xD;
            -  Body weight instability (change in body weight of more than 5% over the preceding 3&#xD;
               months);&#xD;
  &#xD;
            -  Use of current regular prescription or over-the-counter medications that in the&#xD;
               opinion of the Investigators may affect participant safety or outcome measures;&#xD;
  &#xD;
            -  Clinically significant abnormalities in screening blood tests abnormalities which in&#xD;
               the opinion of the study physician, is clinically significant e.g. diabetes mellitus,&#xD;
               hypothyroidism, renal impairment, abnormal liver function tests [bilirubin, alanine&#xD;
               transaminase (ALT), aspartate transaminase (AST), gamma-glutamyl transferase (GGT)]&#xD;
               &gt;3x upper limit of normal, other than due to fatty liver disease; Current pregnancy or&#xD;
               breast-feeding in female volunteers (the Investigators will recommend using&#xD;
               contraception for the duration of the visits to avoid participant drop-out);&#xD;
  &#xD;
            -  Pulse rate &lt;40 or &gt;100 beats per minute OR systolic blood pressure &gt;160 and &lt;100 OR&#xD;
               diastolic blood pressure &gt;95 and &lt;50 in the semi-supine position;&#xD;
  &#xD;
            -  Volunteer has participated in a clinical trial and has received an investigational&#xD;
               product within the following time period prior to the first experimental visit in the&#xD;
               current study: 90 days, 5 half-lives or twice the duration of the biological effect of&#xD;
               the investigational product (whichever is longer);&#xD;
  &#xD;
            -  Exposure to more than 3 new investigational medicinal products within 12 months prior&#xD;
               to the scan;&#xD;
  &#xD;
            -  Vegan, gluten or lactose-intolerant (as test meals in the paradigms may include animal&#xD;
               products, dairy and wheat products);&#xD;
  &#xD;
            -  Volunteers who have donated, or intend to donate, blood within three months before the&#xD;
               screening visit or following study visit completion;&#xD;
  &#xD;
            -  Known history of SARS-CoV-2 infection (Covid-19) in the last 4 weeks;&#xD;
  &#xD;
            -  Ongoing symptoms suggestive of complications from previous SARS-CoV-2 infection ('long&#xD;
               Covid-19') such as loss or change in sense of smell or taste, shortness of breath,&#xD;
               palpitations, lethargy;&#xD;
  &#xD;
            -  SCOFF questionnaire score &gt;1/5 indicating eating disorders (Luck et al. 2002);&#xD;
  &#xD;
            -  DSM-V criteria for alcohol use disorder (AUD) &gt;2/11 indicating mild AUD&#xD;
               (American-Psychiatric-Association 2013);&#xD;
  &#xD;
            -  Participants who have had previous obesity surgery or are on medications for obesity.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Tony Goldstone, MRCP PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Imperial College London</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Tony Goldstone, MRCP PhD</last_name>
      <phone>+44 20 7594 5989</phone>
      <email>tony.goldstone@imperial.ac.uk</email>
    </overall_contact>
    <location>
      <facility>
        <name>PsychoNeuroEndocrinology Research Group, Division of Psychiatry, Dept. of Brain Sciences, Imperial College London</name>
        <address>
          <city>London</city>
          <zip>W12 0NN</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Tony Goldstone, MRCP PhD</last_name>
        <phone>+44 20 7594 5989</phone>
        <email>tony.goldstone@imperial.ac.uk</email>
      </contact>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>LEAP2</keyword>
    <keyword>ghrelin</keyword>
    <keyword>appetite</keyword>
    <keyword>food intake</keyword>
    <keyword>eating behaviour</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06013592
  org study id: 23HH8298
  nct id: NCT06013592
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this interventional study is to measure the blood levels of the gut hormones
        LEAP2 and acyl ghrelin (AG), appetite and food intake after consuming liquid meals of
        different caloric sizes, in healthy adults with and without obesity.
  
        AG is a stomach-derived homone that increases appetite, and LEAP2 a liver-gut derived hormone
        that decreases appetite, which interferes the action of AG ant its receptor in the brain
        called the growth hormone secretagogue receptor (GHSR). Blood levels of AG and LEAP2 change
        in opposite directions after food intake (AG decreasing, LEAP2 increasing). AG is formed from
        an inactive version of hormone called desacyl ghrelin (DAG). Previous studies have shown that
        greater food intake leads to a greater decrease in blood levels of total ghrelin (AG + DAG),
        but this has not been studied for changes in blood AG or LEAP2 after eating. Blood levels of
        AG and total ghrelin when fasted and after food intake are lower, while blood levels of LEAP2
        are higher, in adults with than those without obesity.
  
        The main study questions are:
  
          1. Are there greater increases in blood levels of LEAP2 and greater decreases in blood
             levels of AG after consuming larger meals (by amount of calories they contain)?
  
          2. Are greater decreases in appetite after connsuming larger meals related to greater
             increases in blood levels of LEAP2 and greater decreases in blood levels of AG?
  
          3. Are greater decreases in food intake at a buffet lunch after consuming larger meals
             eaten a few hours previously related to greater increases in blood levels of LEAP2 and
             greater decreases in blood levels of AG?
  
          4. Do the above findings differ between adults without obesity and with obesity?
  
        Healthy adults (without and with obesity) will consume liquid meals containing different
        amounts of calories (0, 600, 1200, 1800 kcal, of identical total volume) after an overnight
        fast and have measurements of blood LEAP2 and AG and appetite ratings from 0 to 180 min, and
        have food intake at a buffet lunch measured at 180 mins.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: within participant
  primary purpose: Basic Science
  masking: Single (Participant)
  masking description: single-blinded, randomized order
  measure: Post-prandial plasma concentration acyl ghrelin
  time frame: 0, 30, 60, 120, 180 minutes
  description: Incremental area under curve (iAUC 0-180 minutes)
  measure: Post-prandial plasma concentration LEAP2
  time frame: 0, 30, 60, 120, 180 minutes
  description: Incremental area under curve (iAUC 0-180 minutes)
  measure: VAS ratings of appetite
  time frame: 0, 30, 60, 120, 180 minutes
  description: Incremental area under curve (iAUC 0-180 minutes)
  measure: Ad libitum food intake
  time frame: 180 minutes
  description: Total kilocalories adjusted for estimated percentage of resting energy expenditure
  arm group label: Healthy adults without obesity
  arm group type: Experimental
  description: Liquid meals with different caloric sizes (0-1800 kcal)
  arm group label: Healthy adults with obesity
  arm group type: Experimental
  description: Liquid meals with different caloric sizes (0-1800 kcal)
  intervention type: Other
  intervention name: 0 kcal liquid
  description: Flavoured water
  arm group label: Healthy adults with obesity
  arm group label: Healthy adults without obesity
  intervention type: Dietary Supplement
  intervention name: 600 kcal liquid meal
  description: Fortisip Compact Vanilla
  arm group label: Healthy adults with obesity
  arm group label: Healthy adults without obesity
  intervention type: Dietary Supplement
  intervention name: 1200 kcal liquid meal
  description: Fortisip Compact Vanilla
  arm group label: Healthy adults with obesity
  arm group label: Healthy adults without obesity
  intervention type: Dietary Supplement
  intervention name: 1800 kcal liquid meal
  description: Fortisip Compact Vanilla
  arm group label: Healthy adults with obesity
  arm group label: Healthy adults without obesity
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Tony Goldstone, MRCP PhD
  role: Principal Investigator
  affiliation: Imperial College London
  last name: Tony Goldstone, MRCP PhD
  phone: +44 20 7594 5989
  email: tony.goldstone@imperial.ac.uk
  facility: 
  status: Recruiting
  contact: 
  country: United Kingdom
  responsible party type: Sponsor