<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/NCT01681459</url>
  </required_header>
  <id_info>
    <org_study_id>H-4-2011-060</org_study_id>
    <nct_id>NCT01681459</nct_id>
  </id_info>
  <brief_title>Effects of Lipids on Gastric Emptying, Satiety Hormones, and Appetite in Severe Overweight</brief_title>
  <official_title>Effects of Lipids on Gastric Emptying, Satiety Hormones, and Appetite in Severe Overweight</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hvidovre University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hvidovre University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In lean subjects, free fatty acid (FFA) promotes gut hormone release, delays gastric&#xD;
      emptying, and reduces appetite and energy intake more than an isocaloric load of triglyceride&#xD;
      (TG). In obesity, the gastrointestinal sensitivity to food components may be reduced. In this&#xD;
      study, the investigators compare the effects of the FFA oleic acid and the TG olive oil on&#xD;
      gut hormone secretion, gastric emptying, appetite sensation, and subsequent energy intake in&#xD;
      lean and severely obese subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nutritional lipid within the lumen of small intestine causes a range of physiological&#xD;
      responses that suppress appetite and reduce energy intake. Thus, intestinal fat promotes the&#xD;
      release of gastrointestinal hormones such as cholecystokinin (CCK), peptide-YY (PYY) and&#xD;
      glucagon-like peptide-1 (GLP-1) that modulate gastrointestinal motility and are important for&#xD;
      appetite regulation and food consumption.&#xD;
&#xD;
      The effect of ingested fat on gut hormone secretion is highly dependent on the lipolysis of&#xD;
      triglycerides (TGs) into free fatty acids (FFAs). It has been demonstrated that adding a&#xD;
      lipase inhibitor (tetrahydrolipstatin) to a pure fat meal accelerates gastric emptying and&#xD;
      reduces CCK release. Furthermore, administration of tetrahydrolipstatin with an intraduodenal&#xD;
      infusion of TG attenuates gastric relaxation and antro-pyloro-duodenal motility and reduces&#xD;
      the release of CCK, PYY, and GLP-1 compared to TG alone. Finally, intragastric administration&#xD;
      of FFA delays gastric emptying and augments the release of CCK and PYY compared to an&#xD;
      isocaloric administration of TG. Hence, the presence of FFAs more than TGs within the small&#xD;
      intestine seem to play a pivotal role in the regulation of appetite and energy intake.&#xD;
&#xD;
      Whereas acute intake of FFA represents a potent stimulus for suppression of appetite and&#xD;
      energy intake, epidemiological evidence relates long-term high dietary fat intake with&#xD;
      obesity and it is known that obese individuals prefer food with high fat content. The&#xD;
      mechanisms behind this paradox remain unclear. However, sustained high fat-diet may change&#xD;
      gastromotor responses and gut hormonal release to a dietary load of lipids. Moreover&#xD;
      intraduodenal sensitivity to FFA (oleic acid) was recently reported to be reduced in obese&#xD;
      subjects. The reduced appetite and energy intake after FFAs compared to TGs may, therefore,&#xD;
      not apply to obese subjects.&#xD;
&#xD;
      The aims of this study are to evaluate gastric emptying, gut hormone secretion, appetite&#xD;
      sensation, and energy intake after isocaloric gastric administration of FFA (oleic acid) and&#xD;
      TG (olive oil) in lean and severely obese subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Prospective</time_perspective>
  </study_design_info>
  <enrollment type="Actual">20</enrollment>
  <condition>Effects of Lipids on Gastric Emptying</condition>
  <condition>Effects of Lipids on Satiety Hormones</condition>
  <condition>Effects of Lipids on Appetite</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        10 lean subjects and 10 severely obese subjects&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Lean subjects: BMI 20-25&#xD;
&#xD;
          -  Severely obese subjects: BMI &gt; 50&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -Gastrointestinal symptoms&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hvidovre Hospital</name>
      <address>
        <city>Hvidovre</city>
        <zip>DK-2650</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <last_update_submitted>February 18, 2016</last_update_submitted>
  <last_update_submitted_qc>February 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hvidovre University Hospital</investigator_affiliation>
    <investigator_full_name>Jan Lysgaard Madsen</investigator_full_name>
    <investigator_title>Chief Physician, MD, DMSci</investigator_title>
  </responsible_party>
  <keyword>Free fatty acid</keyword>
  <keyword>Triglyceride</keyword>
  <keyword>Gastric emptying</keyword>
  <keyword>Satiety hormones</keyword>
  <keyword>Appetite</keyword>
  <keyword>Severe obesity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <!-- 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/NCT01681459
org study id: H-4-2011-060
nct id: NCT01681459
lead sponsor: 
has dmc: Yes
In lean subjects, free fatty acid (FFA) promotes gut hormone release, delays gastric
      emptying, and reduces appetite and energy intake more than an isocaloric load of triglyceride
      (TG). In obesity, the gastrointestinal sensitivity to food components may be reduced. In this
      study, the investigators compare the effects of the FFA oleic acid and the TG olive oil on
      gut hormone secretion, gastric emptying, appetite sensation, and subsequent energy intake in
      lean and severely obese subjects.
Nutritional lipid within the lumen of small intestine causes a range of physiological
      responses that suppress appetite and reduce energy intake. Thus, intestinal fat promotes the
      release of gastrointestinal hormones such as cholecystokinin (CCK), peptide-YY (PYY) and
      glucagon-like peptide-1 (GLP-1) that modulate gastrointestinal motility and are important for
      appetite regulation and food consumption.

      The effect of ingested fat on gut hormone secretion is highly dependent on the lipolysis of
      triglycerides (TGs) into free fatty acids (FFAs). It has been demonstrated that adding a
      lipase inhibitor (tetrahydrolipstatin) to a pure fat meal accelerates gastric emptying and
      reduces CCK release. Furthermore, administration of tetrahydrolipstatin with an intraduodenal
      infusion of TG attenuates gastric relaxation and antro-pyloro-duodenal motility and reduces
      the release of CCK, PYY, and GLP-1 compared to TG alone. Finally, intragastric administration
      of FFA delays gastric emptying and augments the release of CCK and PYY compared to an
      isocaloric administration of TG. Hence, the presence of FFAs more than TGs within the small
      intestine seem to play a pivotal role in the regulation of appetite and energy intake.

      Whereas acute intake of FFA represents a potent stimulus for suppression of appetite and
      energy intake, epidemiological evidence relates long-term high dietary fat intake with
      obesity and it is known that obese individuals prefer food with high fat content. The
      mechanisms behind this paradox remain unclear. However, sustained high fat-diet may change
      gastromotor responses and gut hormonal release to a dietary load of lipids. Moreover
      intraduodenal sensitivity to FFA (oleic acid) was recently reported to be reduced in obese
      subjects. The reduced appetite and energy intake after FFAs compared to TGs may, therefore,
      not apply to obese subjects.

      The aims of this study are to evaluate gastric emptying, gut hormone secretion, appetite
      sensation, and energy intake after isocaloric gastric administration of FFA (oleic acid) and
      TG (olive oil) in lean and severely obese subjects.
observational model: Case-Control
time perspective: Prospective
Plasma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 25 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Hvidovre University Hospital
investigator full name: Jan Lysgaard Madsen
investigator title: Chief Physician, MD, DMSci
mesh term: Overweight