<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/NCT03039478</url>
  </required_header>
  <id_info>
    <org_study_id>PolyDose</org_study_id>
    <nct_id>NCT03039478</nct_id>
  </id_info>
  <brief_title>Effect of Different Concentrations of Xylitol and Erythritol on Gut Peptide Release and Gastric Emptying in Humans</brief_title>
  <official_title>Effect of Different Concentrations of Xylitol and Erythritol on the Release of Gastrointestinal Peptides and on Gastric Emptying Rates in Healthy Normal Weight Humans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Xylitol and erythritol have become increasingly popular as sugar substitutes in the food&#xD;
      industry. Both substances are freely available. While glucose ingestion stimulates satiation&#xD;
      hormone secretion in the gut and slows down gastric emptying, artificial sweeteners such as&#xD;
      aspartame, sucralose and acesulfame-K have no such effect. However, acute intake of 50g&#xD;
      xylitol or 75g erythritol in 300mL tap water leads to a marked increase in the satiation&#xD;
      hormones and induces a significant retardation in gastric emptying. The concentrations used&#xD;
      to Show this effect were rather high (50g xylitol and 75g erythritol) and led to bloating and&#xD;
      diarrhea in 60-70% of all subjects two hours after administration. The aim of the present&#xD;
      study is to find an effective concentration of xylitol and erythritol still stimulating&#xD;
      satiation hormone release without any gastrointestinal adverse events.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 24, 2017</start_date>
  <completion_date type="Actual">August 31, 2018</completion_date>
  <primary_completion_date type="Actual">August 31, 2018</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>Parallel assignment</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acute effect on cholecystokinin ( CCK) release</measure>
    <time_frame>changes from baseline to three hours after treatment</time_frame>
    <description>effect on CCK release measured by a commercially available ELISA kit (enzyme-linked immunosorbent assay)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acute effects on gastric emptying</measure>
    <time_frame>changes from baseline to three hours after treatment</time_frame>
    <description>Acute effects on gastric emptying measured by 13C-sodium-acetate breath test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute effects on subjective feelings of hunger and satiety</measure>
    <time_frame>changes from baseline to three hours after treatment</time_frame>
    <description>Acute effects on subjective feelings of hunger and satiety measured by visual analogue scales</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Physiological Satiation Mechanisms</condition>
  <arm_group>
    <arm_group_label>Xylitol 7g in 300mL tap water</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>12 volunteers receive 7g xylitol in 300mL tap water via a nasogastric tube</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Xylitol 17g in 300mL tap water</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>12 volunteers receive 17g xylitol in 300mL tap water via a nasogastric tube</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Xylitol 35g in 300mL tap water</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>12 volunteers receive 35g xylitol in 300mL tap water via a nasogastric tube</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Erythritol 10g in 300mL tap water</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>12 volunteers receive 10g erythritol in 300mL tap water via a nasogastric tube</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Erythritol 25g in 300mL tap water</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>12 volunteers receive 25g erythritol in 300mL tap water via a nasogastric tube</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Erythritol 50g in 300mL tap water</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>12 volunteers receive 50g erythritol in 300mL tap water via a nasogastric tube</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Xylitol 7g</intervention_name>
    <description>Xylitol 7g in 300mL tap water</description>
    <arm_group_label>Xylitol 7g in 300mL tap water</arm_group_label>
    <other_name>E967-Xylitol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Erythritol 10g</intervention_name>
    <description>Erythritol 10g in 300mL tap water</description>
    <arm_group_label>Erythritol 10g in 300mL tap water</arm_group_label>
    <other_name>E968-Erythritol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Xylitol 17g</intervention_name>
    <description>Xylitol 17g in 300mL tap water</description>
    <arm_group_label>Xylitol 17g in 300mL tap water</arm_group_label>
    <other_name>E967-Xylitol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Xylitol 35g</intervention_name>
    <description>Xylitol 35g in 300mL tap water</description>
    <arm_group_label>Xylitol 35g in 300mL tap water</arm_group_label>
    <other_name>E967-Xylitol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Erythritol 25g</intervention_name>
    <description>Erythritol 25g in 300mL tap water</description>
    <arm_group_label>Erythritol 25g in 300mL tap water</arm_group_label>
    <other_name>E968-Erythritol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Erythritol 50g</intervention_name>
    <description>Erythritol 50g in 300mL tap water</description>
    <arm_group_label>Erythritol 50g in 300mL tap water</arm_group_label>
    <other_name>E968-Erythritol</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy normal weight subjects with a body-mass index of 19.0-24.9&#xD;
&#xD;
          -  Normal eating habits (no diets; no dietary changes; no special dietary habits, such as&#xD;
             vegetarian/vegan)&#xD;
&#xD;
          -  Age 18-40 years&#xD;
&#xD;
          -  Stable body weight for at least three months&#xD;
&#xD;
          -  Informed Consent as documented by signature&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre-existing consumption of xylitol or erythritol on a regular basis (usage of xylitol&#xD;
             or erythritol as sugar replacement; xylitol or erythritol containing toothpaste is&#xD;
             allowed)&#xD;
&#xD;
          -  Regular intake of medications (except for oral contraceptives)&#xD;
&#xD;
          -  Evidence of relevant cardiovascular, pulmonary, renal, hepatic, pancreatic,&#xD;
             gastrointestinal, metabolic, endocrinological, neurological, psychiatric or other&#xD;
             diseases at screening&#xD;
&#xD;
          -  Clinically relevant abnormalities in haematological laboratory parameters&#xD;
&#xD;
          -  Food allergies, food intolerance&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Participation in another study with investigational drug within the 30 days preceding&#xD;
             and during the present study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christoph Beglinger, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Basel, Switzerland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Basel</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>September 14, 2018</last_update_submitted>
  <last_update_submitted_qc>September 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 17, 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>Erythritol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03039478
org study id: PolyDose
nct id: NCT03039478
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Xylitol and erythritol have become increasingly popular as sugar substitutes in the food
      industry. Both substances are freely available. While glucose ingestion stimulates satiation
      hormone secretion in the gut and slows down gastric emptying, artificial sweeteners such as
      aspartame, sucralose and acesulfame-K have no such effect. However, acute intake of 50g
      xylitol or 75g erythritol in 300mL tap water leads to a marked increase in the satiation
      hormones and induces a significant retardation in gastric emptying. The concentrations used
      to Show this effect were rather high (50g xylitol and 75g erythritol) and led to bloating and
      diarrhea in 60-70% of all subjects two hours after administration. The aim of the present
      study is to find an effective concentration of xylitol and erythritol still stimulating
      satiation hormone release without any gastrointestinal adverse events.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Parallel assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Acute effect on cholecystokinin ( CCK) release
time frame: changes from baseline to three hours after treatment
description: effect on CCK release measured by a commercially available ELISA kit (enzyme-linked immunosorbent assay)
measure: Acute effects on gastric emptying
time frame: changes from baseline to three hours after treatment
description: Acute effects on gastric emptying measured by 13C-sodium-acetate breath test
measure: Acute effects on subjective feelings of hunger and satiety
time frame: changes from baseline to three hours after treatment
description: Acute effects on subjective feelings of hunger and satiety measured by visual analogue scales
arm group label: Xylitol 7g in 300mL tap water
arm group type: Active Comparator
description: 12 volunteers receive 7g xylitol in 300mL tap water via a nasogastric tube
arm group label: Xylitol 17g in 300mL tap water
arm group type: Active Comparator
description: 12 volunteers receive 17g xylitol in 300mL tap water via a nasogastric tube
arm group label: Xylitol 35g in 300mL tap water
arm group type: Active Comparator
description: 12 volunteers receive 35g xylitol in 300mL tap water via a nasogastric tube
arm group label: Erythritol 10g in 300mL tap water
arm group type: Active Comparator
description: 12 volunteers receive 10g erythritol in 300mL tap water via a nasogastric tube
arm group label: Erythritol 25g in 300mL tap water
arm group type: Active Comparator
description: 12 volunteers receive 25g erythritol in 300mL tap water via a nasogastric tube
arm group label: Erythritol 50g in 300mL tap water
arm group type: Active Comparator
description: 12 volunteers receive 50g erythritol in 300mL tap water via a nasogastric tube
intervention type: Dietary Supplement
intervention name: Xylitol 7g
description: Xylitol 7g in 300mL tap water
arm group label: Xylitol 7g in 300mL tap water
other name: E967-Xylitol
intervention type: Dietary Supplement
intervention name: Erythritol 10g
description: Erythritol 10g in 300mL tap water
arm group label: Erythritol 10g in 300mL tap water
other name: E968-Erythritol
intervention type: Dietary Supplement
intervention name: Xylitol 17g
description: Xylitol 17g in 300mL tap water
arm group label: Xylitol 17g in 300mL tap water
other name: E967-Xylitol
intervention type: Dietary Supplement
intervention name: Xylitol 35g
description: Xylitol 35g in 300mL tap water
arm group label: Xylitol 35g in 300mL tap water
other name: E967-Xylitol
intervention type: Dietary Supplement
intervention name: Erythritol 25g
description: Erythritol 25g in 300mL tap water
arm group label: Erythritol 25g in 300mL tap water
other name: E968-Erythritol
intervention type: Dietary Supplement
intervention name: Erythritol 50g
description: Erythritol 50g in 300mL tap water
arm group label: Erythritol 50g in 300mL tap water
other name: E968-Erythritol
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Christoph Beglinger, Prof
role: Principal Investigator
affiliation: University Hospital, Basel, Switzerland
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Erythritol
sharing ipd: Undecided