<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/NCT02994420</url>
  </required_header>
  <id_info>
    <org_study_id>2015-0525</org_study_id>
    <nct_id>NCT02994420</nct_id>
  </id_info>
  <brief_title>Endocrine and Neural Control of Eating in Women</brief_title>
  <official_title>Steroid Hormones in the Peripheral and Central Control of Eating in Women - Physiological Reactions to Eating in Normal- and Overweight Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital, Zürich</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to better understand how female sex hormones influence the food&#xD;
      intake in the gut system through the release of satiety hormones as well as through central&#xD;
      regulative mechanisms in the brain that subsequently contribute to the control of eating in&#xD;
      healthy women at different stages of the ovarian cycle.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obesity and the associated severe consequences for health, i.e. cardiovascular diseases or&#xD;
      Diabetes Type 2 reach the world-wide level of an epidemic with excessive eating as major&#xD;
      cause of this development. Study results of veterinary physiology as well as in women let&#xD;
      assume that steroid hormones, such as estrogen or progesterone are highly involved in the&#xD;
      regulation of eating behavior and the female body weight. This connection is underpinned with&#xD;
      the fact that prevalence of adiposity is increased in women in comparison to men in the&#xD;
      United States, Switzerland and further countries. A better understanding of the underlying&#xD;
      regulatory mechanisms, which in turn influence the food intake in the gut system through the&#xD;
      release of satiety hormones as well as through central regulative mechanisms in the brain,&#xD;
      provides important foundation in long-term development of new prophylactic and therapeutic&#xD;
      options in reduction and prevention of obesity. This gets even more important, as current&#xD;
      therapeutic options - beside bariatric surgery - could only show limited success.&#xD;
&#xD;
      Satiety is a process in the brain that leads to a meal being ended, whereby the ingested food&#xD;
      causes a reflexive negative feedback mechanism. This mechanism is both fundamentally and&#xD;
      specifically in the acute situation strongly influenced through subjective parameters, e.g.&#xD;
      eating desires, socio-cultural factors, current social circumstances and individual relation&#xD;
      towards eating. Furthermore, food intake is also influenced by genetic factors, whereas e.g.&#xD;
      TaqIA1 allele is known to be associated with obesity. According to current knowledge,&#xD;
      regulation takes place on peripheral as well as on central level, whereas not only steroid&#xD;
      hormones but also satiety hormones - especially cholecystokinin (CCK) and glucagon-like&#xD;
      peptide-1 (GLP-1) - are involved on both levels.&#xD;
&#xD;
      The current study aims to examine the connection of steroid hormones, gastrointestinal&#xD;
      satiety hormones and neuronal activity in the brain through fMRI. Through the obtained data,&#xD;
      the interaction between defined hormone constellations, gastrointestinal satiety hormones and&#xD;
      the activation of specific brain areas in obese and normal-weight women should be evaluated.&#xD;
      The study design involves the comparison of subjective, hedonic evaluation of different&#xD;
      flavoured liquids with different caloric content each through a rating scale as well as&#xD;
      objective peripheral (release of CCK and GLP-1) and central (activation of involved brain&#xD;
      centres through fMRI) regulation processes in fasted and fed condition of each woman in the&#xD;
      two study groups (obese and normal-weighted) in late follicular compared with the luteal&#xD;
      phase of ovarian cycle.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2016</start_date>
  <completion_date type="Actual">December 2019</completion_date>
  <primary_completion_date type="Actual">December 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>fMRI responses to food cues</measure>
    <time_frame>90 min per study day</time_frame>
    <description>Change in blood oxygen dependent signal (BOLD) in exposure to visual food cues will be measured during a fMRI scan and the difference between responses in the fed condition compared with those in the fasted condition</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in CCK (satiety hormone) response curve</measure>
    <time_frame>30 min per study day</time_frame>
    <description>Blood samples will be collected at 0, 5, 10, 15, 20, 25, 30 min following the ingestion of the meal at each experimental visit, giving a specific curve and analyzed to determine the gut hormone responses. The results will be compared between fast and fed condition, between obese and normal weight women and depending on ovarian cycle phase.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in GLP-1 (satiety hormone) response curve</measure>
    <time_frame>30 min per study day</time_frame>
    <description>Blood samples will be collected at 0, 5, 10, 15, 20, 25, 30 min following the ingestion of the meal at each experimental visit, giving a specific curve and analyzed to determine the gut hormone responses. The results will be compared between fast and fed condition, between obese and normal weight women and depending on ovarian cycle phase.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in food preference indicating motivation to purchase food items</measure>
    <time_frame>20 min per study day</time_frame>
    <description>The willingness-to-pay task measures the motivation to obtain food on a gLMS scale. The results will be compared between fast and fed condition, between obese and normal weight women and depending on ovarian cycle phase.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in food preference indicating motivation to exert effort</measure>
    <time_frame>20 min per study day</time_frame>
    <description>The willingness-to-exert-effort task measures the motivation to obtain food on a gLMS scale. The results will be compared between fast and fed condition, between obese and normal weight women and depending on ovarian cycle phase.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary intake</measure>
    <time_frame>30 min per study day</time_frame>
    <description>Measure of the calorie intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hedonic ratings</measure>
    <time_frame>20 min per study day</time_frame>
    <description>Subjective ratings of flavor pleasantness will be collected using psychophysical rating scales (gLMS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective sensory ratings</measure>
    <time_frame>20 min per study day</time_frame>
    <description>Subjective ratings of hunger sensation will be collected using psychophysical rating scales (gLMS)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Normal Body Weight</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Lean women</arm_group_label>
    <description>BMI 18-25, weight in kg / height in m2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Obese women</arm_group_label>
    <description>BMI 30-35, weight in kg / height in m2</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood to determine hormonal parameters (gut hormones and reproductive hormones) and the&#xD;
      presence of the gene TaqIA1.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Normal-weight and obese women with regular menstrual cycles.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Physically and psychiatrically healthy women&#xD;
&#xD;
          -  Stable body weight (no changes ≥ 5 kg in past year)&#xD;
&#xD;
          -  Age 18-35 years&#xD;
&#xD;
          -  Regular menses (26-32 d cycles)&#xD;
&#xD;
          -  Right-handed&#xD;
&#xD;
          -  German language fluency&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Life history of eating disorders&#xD;
&#xD;
          -  Aversion to the test foods&#xD;
&#xD;
          -  Pacemaker or neurostimulator&#xD;
&#xD;
          -  Hearing aid&#xD;
&#xD;
          -  Surgery to head or heart&#xD;
&#xD;
          -  Potential metal parts in body (pacemakers, metal splinters, gun wounds, shrapnel or&#xD;
             surgical clips)&#xD;
&#xD;
          -  Neurological or psychiatric problems or serious brain injury (such as alcohol or drug&#xD;
             abuse, depression, schizophrenia, bipolar disorders, anxiety disorder, claustrophobia,&#xD;
             Parkinson's disease, multiple sclerosis, epilepsy)&#xD;
&#xD;
          -  High blood pressure, low blood pressure, history of heart disease, irregular heart&#xD;
             rate&#xD;
&#xD;
          -  Emphysema, chest or respiratory problems (including difficulty breathing through the&#xD;
             nose)&#xD;
&#xD;
          -  Pregnancy, nursing or pregnancy planned in next three months&#xD;
&#xD;
          -  History of gall bladder disease or symptoms (right upper abdominal quadrant pain after&#xD;
             meals)&#xD;
&#xD;
          -  Polycystic ovary syndrome, as gauged by testosterone levels&#xD;
&#xD;
          -  Allergy or sensitivity to lactose&#xD;
&#xD;
          -  Allergy to quinine&#xD;
&#xD;
          -  Current or previous malignancies&#xD;
&#xD;
          -  History of difficult blood sampling&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brigitte Leeners, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinic for Reproductive Endocrinology, University Hospital Zurich</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Loredana Asarian, Phd</last_name>
    <role>Study Chair</role>
    <affiliation>Institute of Veterinary Physiology, Universirty of Zurich</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Philippe Tobler, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Economics, University of Zurich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinic for Reproductive Endocrinology, University Hospital Zurich</name>
      <address>
        <city>Zurich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>August 11, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>September 27, 2022</last_update_submitted>
  <last_update_submitted_qc>September 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Menstrual Cycle</keyword>
  <keyword>Gonadal Steroid Hormones</keyword>
  <keyword>Satiety Response</keyword>
  <keyword>Glucagon-Like Peptide 1</keyword>
  <keyword>Cholecystokinin</keyword>
  <keyword>Magnetic Resonance Imaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Body Weight</mesh_term>
  </condition_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/NCT02994420
org study id: 2015-0525
nct id: NCT02994420
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to better understand how female sex hormones influence the food
      intake in the gut system through the release of satiety hormones as well as through central
      regulative mechanisms in the brain that subsequently contribute to the control of eating in
      healthy women at different stages of the ovarian cycle.
Obesity and the associated severe consequences for health, i.e. cardiovascular diseases or
      Diabetes Type 2 reach the world-wide level of an epidemic with excessive eating as major
      cause of this development. Study results of veterinary physiology as well as in women let
      assume that steroid hormones, such as estrogen or progesterone are highly involved in the
      regulation of eating behavior and the female body weight. This connection is underpinned with
      the fact that prevalence of adiposity is increased in women in comparison to men in the
      United States, Switzerland and further countries. A better understanding of the underlying
      regulatory mechanisms, which in turn influence the food intake in the gut system through the
      release of satiety hormones as well as through central regulative mechanisms in the brain,
      provides important foundation in long-term development of new prophylactic and therapeutic
      options in reduction and prevention of obesity. This gets even more important, as current
      therapeutic options - beside bariatric surgery - could only show limited success.

      Satiety is a process in the brain that leads to a meal being ended, whereby the ingested food
      causes a reflexive negative feedback mechanism. This mechanism is both fundamentally and
      specifically in the acute situation strongly influenced through subjective parameters, e.g.
      eating desires, socio-cultural factors, current social circumstances and individual relation
      towards eating. Furthermore, food intake is also influenced by genetic factors, whereas e.g.
      TaqIA1 allele is known to be associated with obesity. According to current knowledge,
      regulation takes place on peripheral as well as on central level, whereas not only steroid
      hormones but also satiety hormones - especially cholecystokinin (CCK) and glucagon-like
      peptide-1 (GLP-1) - are involved on both levels.

      The current study aims to examine the connection of steroid hormones, gastrointestinal
      satiety hormones and neuronal activity in the brain through fMRI. Through the obtained data,
      the interaction between defined hormone constellations, gastrointestinal satiety hormones and
      the activation of specific brain areas in obese and normal-weight women should be evaluated.
      The study design involves the comparison of subjective, hedonic evaluation of different
      flavoured liquids with different caloric content each through a rating scale as well as
      objective peripheral (release of CCK and GLP-1) and central (activation of involved brain
      centres through fMRI) regulation processes in fasted and fed condition of each woman in the
      two study groups (obese and normal-weighted) in late follicular compared with the luteal
      phase of ovarian cycle.
observational model: Case-Control
time perspective: Cross-Sectional
measure: fMRI responses to food cues
time frame: 90 min per study day
description: Change in blood oxygen dependent signal (BOLD) in exposure to visual food cues will be measured during a fMRI scan and the difference between responses in the fed condition compared with those in the fasted condition
measure: Change in CCK (satiety hormone) response curve
time frame: 30 min per study day
description: Blood samples will be collected at 0, 5, 10, 15, 20, 25, 30 min following the ingestion of the meal at each experimental visit, giving a specific curve and analyzed to determine the gut hormone responses. The results will be compared between fast and fed condition, between obese and normal weight women and depending on ovarian cycle phase.
measure: Change in GLP-1 (satiety hormone) response curve
time frame: 30 min per study day
description: Blood samples will be collected at 0, 5, 10, 15, 20, 25, 30 min following the ingestion of the meal at each experimental visit, giving a specific curve and analyzed to determine the gut hormone responses. The results will be compared between fast and fed condition, between obese and normal weight women and depending on ovarian cycle phase.
measure: Change in food preference indicating motivation to purchase food items
time frame: 20 min per study day
description: The willingness-to-pay task measures the motivation to obtain food on a gLMS scale. The results will be compared between fast and fed condition, between obese and normal weight women and depending on ovarian cycle phase.
measure: Change in food preference indicating motivation to exert effort
time frame: 20 min per study day
description: The willingness-to-exert-effort task measures the motivation to obtain food on a gLMS scale. The results will be compared between fast and fed condition, between obese and normal weight women and depending on ovarian cycle phase.
measure: Dietary intake
time frame: 30 min per study day
description: Measure of the calorie intake
measure: Hedonic ratings
time frame: 20 min per study day
description: Subjective ratings of flavor pleasantness will be collected using psychophysical rating scales (gLMS)
measure: Subjective sensory ratings
time frame: 20 min per study day
description: Subjective ratings of hunger sensation will be collected using psychophysical rating scales (gLMS)
arm group label: Lean women
description: BMI 18-25, weight in kg / height in m2
arm group label: Obese women
description: BMI 30-35, weight in kg / height in m2
Whole blood to determine hormonal parameters (gut hormones and reproductive hormones) and the
      presence of the gene TaqIA1.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Brigitte Leeners, MD
role: Principal Investigator
affiliation: Clinic for Reproductive Endocrinology, University Hospital Zurich
last name: Loredana Asarian, Phd
role: Study Chair
affiliation: Institute of Veterinary Physiology, Universirty of Zurich
last name: Philippe Tobler, Prof
role: Study Chair
affiliation: Department of Economics, University of Zurich
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Body Weight
sharing ipd: No