<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/NCT03227900</url>
  </required_header>
  <id_info>
    <org_study_id>METC 163054</org_study_id>
    <nct_id>NCT03227900</nct_id>
  </id_info>
  <brief_title>Lidocaine and Food Intake</brief_title>
  <official_title>The Effect of lidocaïne Infusion on ad Libitum Food Intake and Satiety in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maastricht University Medical Center</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      World's population over 60 years old is increasing rapidly. It is expected that in 2050&#xD;
      elderly population will be 22% of the total population, representing around 2 billion people.&#xD;
      This situation means a rising in the incidence of elderly-related diseases, and thereby the&#xD;
      need for long-term care. Reduction in body fat and weight are a common problem among the&#xD;
      institutionalized elderly. Some factors that contribute to the anorexia of aging are&#xD;
      decreased perception of hunger and increased satiation. This represents an increased risk of&#xD;
      developing cachexia even during minor illnesses. The potentially severe consequences of&#xD;
      anorexia of aging a greater understanding of the underlying mechanism of these changes is&#xD;
      highly important. Intraesophageal and intragastric infusion of 20mg/kg lidocaine results in&#xD;
      an increase in food intake in Wistar rats. All infusions were done 30 minutes before the&#xD;
      start of the meal intake (meal consisted of mealworms). It may be possible to decrease&#xD;
      satiation, increase hunger, and hence food intake in elderly individuals through gastric&#xD;
      infusion of the anesthetics lidocaine or benzocaine. In the future this study could&#xD;
      potentially contribute to improve food intake in elderly vulnerable of losing body weight.&#xD;
      Therefore, the current study aims to investigate the effect of intragastric administration of&#xD;
      lidocaine on food intake, satiety/satiation and gastrointestinal complaints.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim: To determine the effect of intragastric infusion of lidocaine on satiation,&#xD;
      gastrointestinal complaints and food intake.&#xD;
&#xD;
      Hypothesis: We hypothesize that intragastric administration of lidocaine will result in a&#xD;
      delay of postprandial satiation and hereby will result in an increase in food intake.&#xD;
      Furthermore, lidocaine infusion will not result in an increase in any gastrointestinal&#xD;
      complaints.&#xD;
&#xD;
      Primary objective: To investigate the effect of intragastric infusion of lidocaine on ad&#xD;
      libitum food intake.&#xD;
&#xD;
      Secondary Objective(s):&#xD;
&#xD;
        1. To investigate the effect of intragastric infusion of lidocaine on satiety/satiation.&#xD;
&#xD;
        2. To study the effect of intragastric infusion of lidocaine on gastrointestinal&#xD;
           complaints.&#xD;
&#xD;
      Design: Double blind randomized placebo-controlled cross-over trial in healthy male&#xD;
      volunteers.&#xD;
&#xD;
      Study population: 35 healthy human male volunteers, 18 - 50 years old. Main study&#xD;
      parameters/endpoints: Difference in ad libitum meal intake (as measured during ad libitum&#xD;
      chili con carne meal).&#xD;
&#xD;
      Nature and extent of the burden and risks associated with participation, benefit and group&#xD;
      relatedness: Visual Analogue Scales (VAS) scores for satiety feelings (e.g., satiety,&#xD;
      fullness, hunger, prospective feeding, desire to eat, desire to snack) and gastrointestinal&#xD;
      symptoms (burning, bloating, belching, cramps, colics, warm sensation, sensation of abdominal&#xD;
      fullness, nausea and pain) will be measured using VAS (0 to 100 mm) anchored at the low end&#xD;
      with the most negative or lowest intensity feelings (e.g., extremely unpleasant, not at all),&#xD;
      and with opposing terms at the high end (e.g., extremely pleasant, very high, extreme).&#xD;
      Volunteers will be asked to indicate on a line which place on the scale best reflects their&#xD;
      feeling at that moment. The scoring forms will be collected immediately so that they cannot&#xD;
      be used as a reference for later scorings.&#xD;
&#xD;
      Catheter placement: the subjects will perceive mild discomfort during the placement of the&#xD;
      catheter. Subjects can, at any time, come in contact with the investigator if any problems&#xD;
      occur. All participants are healthy volunteers and we don't expect any health benefits or&#xD;
      disadvantages.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 19, 2017</start_date>
  <completion_date type="Actual">June 26, 2018</completion_date>
  <primary_completion_date type="Actual">June 26, 2018</primary_completion_date>
  <phase>Phase 4</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>Double blind randomized cross over trial</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Masking of participant and investigator</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in ad libitum meal intake after intragastric lidocain infusion compared to placebo</measure>
    <time_frame>Difference between Test day 1 and Test day 2 (minimal wash out of 7 days)</time_frame>
    <description>The difference in ad libitum food intake (kcal) after intragastric infusion of lidocaine and placebo and active within a subject.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in visual analogue scores for gastrointestinal complaints after intragastric lidocain infusion compared to placebo.</measure>
    <time_frame>15 minutes before the start of the infusion of placebo or lidocaine and after the start of the infusion every 15 minutes, until 90 minutes after start of infusion (8 times total).</time_frame>
    <description>During a test day participants fill in 8 visual analogue scores (VAS) for gastrointestinal complaints (different time points). VAS scores will be recorded on a scale (0-100, 100mm) and will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in visual analogue scores for satiation after intragastric lidocain infusion compared to placebo.</measure>
    <time_frame>15 minutes before the start of the infusion of placebo or lidocaine and after the start of the infusion every 15 minutes, until 90 minutes after start of infusion (8 times total).</time_frame>
    <description>During a test day participants fill in 8 visual analogue scores (VAS) for satiation (different time points). VAS scores will be recorded on a scale (0-100, 100mm) and will be measured.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Hunger</condition>
  <arm_group>
    <arm_group_label>Lidocaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>LIdocaine dissolved in water for injections</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Water for injections</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine</intervention_name>
    <description>Intragastric infusion of lidocain</description>
    <arm_group_label>Lidocaine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>Intragastric infusion of water for injections</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>water for injections</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Based on medical history and previous examination, no gastrointestinal complaints can&#xD;
             be defined.&#xD;
&#xD;
          -  Age between 18 and 50 years. Several studies (see introduction) showed a difference in&#xD;
             response to a meal between young and elderly people. Inclusion of elderly could&#xD;
             interfere with the outcome of this study. Goal of this study is to investigate whether&#xD;
             a difference in food intake can be found after intragastric infusion of a local&#xD;
             anaesthetic. For this proof of concept study we therefore choose to include healthy&#xD;
             male volunteers with a maximum age of 50 years.&#xD;
&#xD;
          -  BMI between 20 and 25 kg/m2&#xD;
&#xD;
          -  Weight stable over at least the last 6 months (≤5% weight change)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Females, because of their hormonal cycle and the possible influence of these hormones&#xD;
             on eating behaviour.&#xD;
&#xD;
          -  History of severe cardiovascular, respiratory, urogenital, gastrointestinal/hepatic,&#xD;
             haematological/immunologic, HEENT (head, ears, eyes, nose, throat),&#xD;
             dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine,&#xD;
             neurological/psychiatric diseases, allergy, major surgery and/or laboratory&#xD;
             assessments which might limit participation in or completion of the study protocol.&#xD;
             The severity of the disease (major interference with the execution of the experiment&#xD;
             or potential influence on the study outcomes) will be decided by the principal&#xD;
             investigator.&#xD;
&#xD;
          -  Use of amiodaron, because of the cardiotoxicity (in combination with lidocaine).&#xD;
&#xD;
          -  Use of beta blockers, cimetidine and norepinephrine (synergetic effect on the action&#xD;
             of Lidocaine).&#xD;
&#xD;
          -  Other use of medication, which could interfere with the outcome of the study. This&#xD;
             will be decided by the principal investigator.&#xD;
&#xD;
          -  Administration of investigational drugs or participation in any scientific&#xD;
             intervention study which may interfere with this study (to be decided by the principle&#xD;
             investigator), in the 90 days prior to the study&#xD;
&#xD;
          -  Major abdominal surgery interfering with gastrointestinal function (uncomplicated&#xD;
             appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon&#xD;
             judgement of the principle investigator)&#xD;
&#xD;
          -  Dieting (medically prescribed, vegetarian, diabetic, macrobiological, biological&#xD;
             dynamic)&#xD;
&#xD;
          -  Excessive alcohol consumption (&gt;20 alcoholic consumptions per week)&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Self-admitted HIV-positive state&#xD;
&#xD;
          -  Any food allergy&#xD;
&#xD;
          -  Not able to eat a chili con carne meal.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Only males are eligible, because of the hormonal influence on food intake in females</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ad Masclee, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maastricht University Medical Center (MUMC+)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maastricht University Medical Centre</name>
      <address>
        <city>Maastricht</city>
        <state>Limburg</state>
        <zip>6229 HX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>July 12, 2017</study_first_submitted>
  <study_first_submitted_qc>July 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>July 31, 2018</last_update_submitted>
  <last_update_submitted_qc>July 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
  </intervention_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/NCT03227900
org study id: METC 163054
nct id: NCT03227900
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
World's population over 60 years old is increasing rapidly. It is expected that in 2050
      elderly population will be 22% of the total population, representing around 2 billion people.
      This situation means a rising in the incidence of elderly-related diseases, and thereby the
      need for long-term care. Reduction in body fat and weight are a common problem among the
      institutionalized elderly. Some factors that contribute to the anorexia of aging are
      decreased perception of hunger and increased satiation. This represents an increased risk of
      developing cachexia even during minor illnesses. The potentially severe consequences of
      anorexia of aging a greater understanding of the underlying mechanism of these changes is
      highly important. Intraesophageal and intragastric infusion of 20mg/kg lidocaine results in
      an increase in food intake in Wistar rats. All infusions were done 30 minutes before the
      start of the meal intake (meal consisted of mealworms). It may be possible to decrease
      satiation, increase hunger, and hence food intake in elderly individuals through gastric
      infusion of the anesthetics lidocaine or benzocaine. In the future this study could
      potentially contribute to improve food intake in elderly vulnerable of losing body weight.
      Therefore, the current study aims to investigate the effect of intragastric administration of
      lidocaine on food intake, satiety/satiation and gastrointestinal complaints.
Aim: To determine the effect of intragastric infusion of lidocaine on satiation,
      gastrointestinal complaints and food intake.

      Hypothesis: We hypothesize that intragastric administration of lidocaine will result in a
      delay of postprandial satiation and hereby will result in an increase in food intake.
      Furthermore, lidocaine infusion will not result in an increase in any gastrointestinal
      complaints.

      Primary objective: To investigate the effect of intragastric infusion of lidocaine on ad
      libitum food intake.

      Secondary Objective(s):

        1. To investigate the effect of intragastric infusion of lidocaine on satiety/satiation.

        2. To study the effect of intragastric infusion of lidocaine on gastrointestinal
           complaints.

      Design: Double blind randomized placebo-controlled cross-over trial in healthy male
      volunteers.

      Study population: 35 healthy human male volunteers, 18 - 50 years old. Main study
      parameters/endpoints: Difference in ad libitum meal intake (as measured during ad libitum
      chili con carne meal).

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness: Visual Analogue Scales (VAS) scores for satiety feelings (e.g., satiety,
      fullness, hunger, prospective feeding, desire to eat, desire to snack) and gastrointestinal
      symptoms (burning, bloating, belching, cramps, colics, warm sensation, sensation of abdominal
      fullness, nausea and pain) will be measured using VAS (0 to 100 mm) anchored at the low end
      with the most negative or lowest intensity feelings (e.g., extremely unpleasant, not at all),
      and with opposing terms at the high end (e.g., extremely pleasant, very high, extreme).
      Volunteers will be asked to indicate on a line which place on the scale best reflects their
      feeling at that moment. The scoring forms will be collected immediately so that they cannot
      be used as a reference for later scorings.

      Catheter placement: the subjects will perceive mild discomfort during the placement of the
      catheter. Subjects can, at any time, come in contact with the investigator if any problems
      occur. All participants are healthy volunteers and we don't expect any health benefits or
      disadvantages.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Double blind randomized cross over trial
primary purpose: Basic Science
masking: Double (Participant, Investigator)
masking description: Masking of participant and investigator
measure: Difference in ad libitum meal intake after intragastric lidocain infusion compared to placebo
time frame: Difference between Test day 1 and Test day 2 (minimal wash out of 7 days)
description: The difference in ad libitum food intake (kcal) after intragastric infusion of lidocaine and placebo and active within a subject.
measure: Difference in visual analogue scores for gastrointestinal complaints after intragastric lidocain infusion compared to placebo.
time frame: 15 minutes before the start of the infusion of placebo or lidocaine and after the start of the infusion every 15 minutes, until 90 minutes after start of infusion (8 times total).
description: During a test day participants fill in 8 visual analogue scores (VAS) for gastrointestinal complaints (different time points). VAS scores will be recorded on a scale (0-100, 100mm) and will be measured.
measure: Difference in visual analogue scores for satiation after intragastric lidocain infusion compared to placebo.
time frame: 15 minutes before the start of the infusion of placebo or lidocaine and after the start of the infusion every 15 minutes, until 90 minutes after start of infusion (8 times total).
description: During a test day participants fill in 8 visual analogue scores (VAS) for satiation (different time points). VAS scores will be recorded on a scale (0-100, 100mm) and will be measured.
arm group label: Lidocaine
arm group type: Active Comparator
description: LIdocaine dissolved in water for injections
arm group label: Placebo
arm group type: Placebo Comparator
description: Water for injections
intervention type: Drug
intervention name: Lidocaine
description: Intragastric infusion of lidocain
arm group label: Lidocaine
intervention type: Drug
intervention name: Placebos
description: Intragastric infusion of water for injections
arm group label: Placebo
other name: water for injections
criteria: 
gender: Male
gender based: Yes
gender description: Only males are eligible, because of the hormonal influence on food intake in females
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ad Masclee, MD, PhD
role: Principal Investigator
affiliation: Maastricht University Medical Center (MUMC+)
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Lidocaine
sharing ipd: No