<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/NCT02219295</url>
  </required_header>
  <id_info>
    <org_study_id>BMBF 11005D</org_study_id>
    <nct_id>NCT02219295</nct_id>
  </id_info>
  <brief_title>SEGATROM: Sensory and Gastrointestinal Impact of Taste Receptor Variants on Human Metabolism and Nutrition</brief_title>
  <acronym>SEGATROM</acronym>
  <official_title>Sensory and Gastrointestinal Impact of Taste Receptor Variants on Human Metabolism and Nutrition</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>German Institute of Human Nutrition</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Technical University of Munich</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>German Institute of Human Nutrition</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We investigate the impact of taste receptors (sweet, bitter and umami) on human metabolism.&#xD;
      There ist growing evidence, that components of the taste signalling system, including the&#xD;
      taste receptor proteins , have important functions in the regulation of metabolic parameters&#xD;
      in non-gustatory tissues.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We apply different sweet, bitter and umami taste compounds in a single dose in the human&#xD;
      intervention. We use substances as for instance glucose, sucrose,saccharin and lactisol in&#xD;
      the sweet part, and substances from cabbage, beer or red endive in the bitter part. For umami&#xD;
      we take glutamate.&#xD;
&#xD;
      Blood samples are collected at baseline and 6 times thereafter up to 3hours, to analyse the&#xD;
      incretins GLP-1(glucagon-like peptide 1) and GIP(gastrointestinal polypeptide) and other&#xD;
      peptide hormones as insulin and PYY(peptide tyrosin trosin) in human beings.&#xD;
&#xD;
      Gastrointestinal mucosa is taken by gastroscopy from the lower duodenum from study subjects&#xD;
      for analysis for the presence or absence of functional taste receptors in gastrointestinal&#xD;
      tissues.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2011</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</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>Factorial Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the curve (AUC): changes of expression levels of the sweet , bitter und umami taste receptors in humans in the upper bowel and responses of incretins to receptor agonists and antagonists</measure>
    <time_frame>three years</time_frame>
    <description>measurement of incretins (GIP, GLP-1) and peptide hormones in human plasma after consumption of different sugars , sweeteners , bitter tasting ingredients of vegetables und umami. Measurement of expression levels in human intestinal mucosa before and after receptor stimulation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>changes in the signalling cascade of the sweet receptor SGLT1 (sodium tranporter 1), changes of receptor expression</measure>
    <time_frame>3 years</time_frame>
    <description>oral application of sweet tasting substances and antagonists, endoscopic collection of tissue samples, determination of molecular resonses by qRT-PCR and immunohistochemistry</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Changes in the Area under the Curve (AUC) for PYY in different bitter tasting substances</measure>
    <time_frame>3 years</time_frame>
    <description>oral application of sinigrin, lactucopicrin and other extracts of vegetables and umami, getting insight into the different bitter receptors</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">97</enrollment>
  <condition>Disorder of Glucose Regulation</condition>
  <arm_group>
    <arm_group_label>sweet -block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>application of different sugars, artificial sweeteners and sweet-taste antagonists in a single dose in 300 ml tap water every week up to 7 times and collection of blood samples over 3 hours</description>
  </arm_group>
  <arm_group>
    <arm_group_label>bitter block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>application of purified bitter tasting ingredients of vegetables and hop in 300 ml tap water , collection of blood samples for 3h (-15,0,15,30,60,120,180 min)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>umami-block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>application of glutamate and glutamate +IMP&#xD;
same procedure as above</description>
  </arm_group>
  <arm_group>
    <arm_group_label>gastroscopy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>gastroscopy with and without oral intervention with artificial sweetener saccharin to take tissue samples from the upper bowel for the investigation of taste receptor cells in the upper bowel in human beings</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>sweet block</intervention_name>
    <description>oral application of the above mentioned substances in 300 ml tap water in 5 min. , collection of blood at 0,15,30, 60 ,120,180 minutes for measurement of incretins GIP(gastrointestinal polypeptide) and GLP-1 (glucagon like peptide 1), Protein hormones PYY(Peptide YY),CCK (cholecystokinin), Leptin and Insulin</description>
    <arm_group_label>bitter block</arm_group_label>
    <arm_group_label>sweet -block</arm_group_label>
    <arm_group_label>umami-block</arm_group_label>
    <other_name>Sugars as sucrose, glucose, palatinose, galactose</other_name>
    <other_name>artificial sweeteners as saccharin</other_name>
    <other_name>sweet taste antagonist as lactisol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>bitter block</intervention_name>
    <description>oral application of the above mentioned substances in 300 ml tap water, collection of blood samples at -15,0,15,30,60,120,180 min for Insulin, GIP,GLP-1, PYY and glucose</description>
    <arm_group_label>bitter block</arm_group_label>
    <arm_group_label>sweet -block</arm_group_label>
    <arm_group_label>umami-block</arm_group_label>
    <other_name>application of</other_name>
    <other_name>sinigrin</other_name>
    <other_name>lactucopicrin</other_name>
    <other_name>iso-alpha-acid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>umami-block</intervention_name>
    <description>oral application of umami substances as glutamate with and without IMP, collection of blood samples as above</description>
    <arm_group_label>bitter block</arm_group_label>
    <arm_group_label>sweet -block</arm_group_label>
    <arm_group_label>umami-block</arm_group_label>
    <other_name>application of glutamate and glutamate+IMP,</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>gastroscopy</intervention_name>
    <description>gastroscopy with and without oral application of saccharin, tissue samples from th upper duodenum by endoscopy for the detection of taste receptor cells in the upper bowel</description>
    <arm_group_label>gastroscopy</arm_group_label>
    <other_name>tissue samples</other_name>
    <other_name>sweet taste receptor stimualtion</other_name>
    <other_name>artificial sweetener saccharin</other_name>
    <other_name>SGLT-1</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy persons&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Tumor in history&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Severe illness in history&#xD;
&#xD;
          -  Bodymass index below 18&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andreas FH Peiffer, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>German Institute of Human Nutrition</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Clinical Nutrition</name>
      <address>
        <city>Bergholz-Rehbrücke</city>
        <state>Brandenburg</state>
        <zip>D-14558</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>June 23, 2020</last_update_submitted>
  <last_update_submitted_qc>June 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>German Institute of Human Nutrition</investigator_affiliation>
    <investigator_full_name>Prof. Dr. med. Andreas F. H. Pfeiffer</investigator_full_name>
    <investigator_title>Prof. Dr. med.</investigator_title>
  </responsible_party>
  <keyword>SGLT1 (sodium dependent glucose transporter)</keyword>
  <keyword>Glut-transporters</keyword>
  <keyword>taste receptors genes</keyword>
  <keyword>sweet taste receptor T1R2T1R3</keyword>
  <keyword>bitter taste receptors of the hTAS2gene family</keyword>
  <!-- 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/NCT02219295
org study id: BMBF 11005D
nct id: NCT02219295
lead sponsor: 
collaborator: 
has dmc: No
We investigate the impact of taste receptors (sweet, bitter and umami) on human metabolism.
      There ist growing evidence, that components of the taste signalling system, including the
      taste receptor proteins , have important functions in the regulation of metabolic parameters
      in non-gustatory tissues.
We apply different sweet, bitter and umami taste compounds in a single dose in the human
      intervention. We use substances as for instance glucose, sucrose,saccharin and lactisol in
      the sweet part, and substances from cabbage, beer or red endive in the bitter part. For umami
      we take glutamate.

      Blood samples are collected at baseline and 6 times thereafter up to 3hours, to analyse the
      incretins GLP-1(glucagon-like peptide 1) and GIP(gastrointestinal polypeptide) and other
      peptide hormones as insulin and PYY(peptide tyrosin trosin) in human beings.

      Gastrointestinal mucosa is taken by gastroscopy from the lower duodenum from study subjects
      for analysis for the presence or absence of functional taste receptors in gastrointestinal
      tissues.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Area under the curve (AUC): changes of expression levels of the sweet , bitter und umami taste receptors in humans in the upper bowel and responses of incretins to receptor agonists and antagonists
time frame: three years
description: measurement of incretins (GIP, GLP-1) and peptide hormones in human plasma after consumption of different sugars , sweeteners , bitter tasting ingredients of vegetables und umami. Measurement of expression levels in human intestinal mucosa before and after receptor stimulation
measure: changes in the signalling cascade of the sweet receptor SGLT1 (sodium tranporter 1), changes of receptor expression
time frame: 3 years
description: oral application of sweet tasting substances and antagonists, endoscopic collection of tissue samples, determination of molecular resonses by qRT-PCR and immunohistochemistry
measure: Changes in the Area under the Curve (AUC) for PYY in different bitter tasting substances
time frame: 3 years
description: oral application of sinigrin, lactucopicrin and other extracts of vegetables and umami, getting insight into the different bitter receptors
arm group label: sweet -block
arm group type: Experimental
description: application of different sugars, artificial sweeteners and sweet-taste antagonists in a single dose in 300 ml tap water every week up to 7 times and collection of blood samples over 3 hours
arm group label: bitter block
arm group type: Experimental
description: application of purified bitter tasting ingredients of vegetables and hop in 300 ml tap water , collection of blood samples for 3h (-15,0,15,30,60,120,180 min)
arm group label: umami-block
arm group type: Experimental
description: application of glutamate and glutamate +IMP
same procedure as above
arm group label: gastroscopy
arm group type: Other
description: gastroscopy with and without oral intervention with artificial sweetener saccharin to take tissue samples from the upper bowel for the investigation of taste receptor cells in the upper bowel in human beings
intervention type: Dietary Supplement
intervention name: sweet block
description: oral application of the above mentioned substances in 300 ml tap water in 5 min. , collection of blood at 0,15,30, 60 ,120,180 minutes for measurement of incretins GIP(gastrointestinal polypeptide) and GLP-1 (glucagon like peptide 1), Protein hormones PYY(Peptide YY),CCK (cholecystokinin), Leptin and Insulin
arm group label: bitter block
arm group label: sweet -block
arm group label: umami-block
other name: Sugars as sucrose, glucose, palatinose, galactose
other name: artificial sweeteners as saccharin
other name: sweet taste antagonist as lactisol
intervention type: Dietary Supplement
intervention name: bitter block
description: oral application of the above mentioned substances in 300 ml tap water, collection of blood samples at -15,0,15,30,60,120,180 min for Insulin, GIP,GLP-1, PYY and glucose
arm group label: bitter block
arm group label: sweet -block
arm group label: umami-block
other name: application of
other name: sinigrin
other name: lactucopicrin
other name: iso-alpha-acid
intervention type: Dietary Supplement
intervention name: umami-block
description: oral application of umami substances as glutamate with and without IMP, collection of blood samples as above
arm group label: bitter block
arm group label: sweet -block
arm group label: umami-block
other name: application of glutamate and glutamate+IMP,
intervention type: Other
intervention name: gastroscopy
description: gastroscopy with and without oral application of saccharin, tissue samples from th upper duodenum by endoscopy for the detection of taste receptor cells in the upper bowel
arm group label: gastroscopy
other name: tissue samples
other name: sweet taste receptor stimualtion
other name: artificial sweetener saccharin
other name: SGLT-1
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Andreas FH Peiffer, Prof
role: Principal Investigator
affiliation: German Institute of Human Nutrition
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: German Institute of Human Nutrition
investigator full name: Prof. Dr. med. Andreas F. H. Pfeiffer
investigator title: Prof. Dr. med.