<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/NCT02973334</url>
  </required_header>
  <id_info>
    <org_study_id>316/15</org_study_id>
    <nct_id>NCT02973334</nct_id>
  </id_info>
  <brief_title>Acute Effects of Artificial Sweeteners or Sugar on Hemodynamic and Metabolic Stress Responses</brief_title>
  <acronym>EduStress</acronym>
  <official_title>Acute Effects of Artificial Sweeteners' or Sugar's Ingestion on Hemodynamic and Metabolic Stress Response: An Exploratory, Randomized, Cross-over Trial in Healthy Young Women.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Lausanne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Lausanne</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This exploratory study aims at investigating the acute effects of artificially sweetened and&#xD;
      sugar beverage consumption (as compared to water consumption) on acute hemodynamic and&#xD;
      metabolic stress response.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This single-center study included five visits. The first two visits (screening and&#xD;
      familiarization) allowed checking the eligibility of the volunteers. In case of inclusion,&#xD;
      the subjects were assigned to a sequence of three experimental conditions (water, sugar and&#xD;
      artificial sweeteners), in a randomized, crossover design.&#xD;
&#xD;
      The experimental test was divided into 5 stages:&#xD;
&#xD;
        1. a 90 minutes baseline period (t=0-90 min),&#xD;
&#xD;
        2. a 30-min mental stress (MS; t=90-120 min), consisting in 5-min periods of Stroop's color&#xD;
           word conflict test alternated with 5-min periods of mental arithmetic test.&#xD;
&#xD;
        3. a 30-min MS recovery period (t=120-150),&#xD;
&#xD;
        4. a 3-min cold pressure test (CPT) was carried out, aiming at immersing one volunteer's&#xD;
           forearm in an ice water container at 3°C,&#xD;
&#xD;
      3) a 15-min CPT recovery period (t=120-150). 60 min after the beginning of the metabolic&#xD;
      test, volunteers will drink 25 mL every 15 min, after 10-sec mouth rinsing, of either an&#xD;
      artificially- or sugar-sweetened beverages or water (control).&#xD;
&#xD;
      Hemodynamic stress responses will be measured by repeated blood pressure, heart rate and&#xD;
      cardiac output. Repeated venous blood samples will allow to assess metabolic stress&#xD;
      responses.&#xD;
&#xD;
      Each condition (water, artificial sweeteners and sugar) will be preceded by a 2-day run-in&#xD;
      period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2015</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hemodynamic changes</measure>
    <time_frame>Differences observed between 90-min baseline and stress (30-min mental stress and 3-min cold pressure test)</time_frame>
    <description>Hemodynamic changes elicited by stress will be assessed by means of systemic vascular resistance calculated as (blood flow):(mean arterial pressure, and expressed in arbitrary units</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in concentration of blood glucose</measure>
    <time_frame>Blood samples will be collected 30, 60, 75, 85, 95, 100, 110, 120, 125, 135, 145, 153, 158, and 163 minutes after the beginning of the test</time_frame>
    <description>Blood glucose concentration will be measured in fasting conditions and during stress tests with the glucose oxidase method and expressed in mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in concentration of blood insulin</measure>
    <time_frame>Blood samples will be collected 30, 60, 75, 85, 95, 100, 110, 120, 125, 135, 145, 153, 158, and 163 minutes after the beginning of the test</time_frame>
    <description>Blood insulin concentration will be measured by ELISA and expressed in mU/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in blood non-esterified fatty acid concentration</measure>
    <time_frame>Blood samples will be collected 30, 60, 75, 85, 95, 100, 110, 120, 125, 135, 145, 153, 158, and 163 minutes after the beginning of the tes</time_frame>
    <description>Blood non-esterified fatty acid concentration will be measured by a colorimetric method and expressed in mmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metabolic changes</measure>
    <time_frame>Differences observed between 90-min baseline and stress (30-min mental stress and 3-min cold pressure test)</time_frame>
    <description>Metabolic changes elicited by stress will be continually monitored from respiratory gas exchanges by indirect calorimetry.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Normal Subjects</condition>
  <arm_group>
    <arm_group_label>Sugar</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Effects of ingestion of sugar-sweetened beverages on acute stress response</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Artificial sweetener</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Effects of ingestion of artificially-sweetened beverages on acute stress response</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Water</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Effects of ingestion of water on acute stress response</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ingestion of artificially-sweetened beverages</intervention_name>
    <description>From t=60 to the end of the metabolic test, volunteers will ingest 7 beverages containing non nutritive sweeteners (25 mL / beverage) every 15 minutes after 10-sec mouth rinsing.</description>
    <arm_group_label>Artificial sweetener</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ingestion of sugar-sweetened beverages</intervention_name>
    <description>From t=60 to the end of the metabolic test, volunteers will ingest 7 beverages containing sugar (25 mL / beverage) every 15 minutes after 10-sec mouth rinsing.</description>
    <arm_group_label>Sugar</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ingestion of water</intervention_name>
    <description>From t=60 to the end of the metabolic test, volunteers will ingest 7 water beverages (25 mL / beverage) every 15 minutes after 10-sec mouth rinsing.</description>
    <arm_group_label>Water</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
          -  Caucasian&#xD;
&#xD;
          -  Normal Body Mass Index (18.5 ≤BMI≤ 25 kg/m2)&#xD;
&#xD;
          -  Monophasic oral contraceptive&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypertension (Blood pressure &gt;140/90 mmHg)&#xD;
&#xD;
          -  History or actual psychologic/cardiovascular troubles&#xD;
&#xD;
          -  Anemia anamnesis&#xD;
&#xD;
          -  Being Pregnant&#xD;
&#xD;
          -  Weight &lt; 50 kg&#xD;
&#xD;
          -  Blood donation or participation to another study &lt; 8 weeks&#xD;
&#xD;
          -  Claustrophobia&#xD;
&#xD;
          -  Consumption of sugar/artifically-sweetened beverages drinks &gt; 5 dL/d&#xD;
&#xD;
          -  Visual disturbances (daltonism)&#xD;
&#xD;
          -  Low to moderate physical activity (&gt; 4h/wk)&#xD;
&#xD;
          -  Smoker and narcotic consumption&#xD;
&#xD;
          -  Caffeine (&gt; 400 mg/d) and/or alcohol (&gt; 10g/d) consumption&#xD;
&#xD;
          -  Medical treatment&#xD;
&#xD;
          -  Weight variation &gt; 3kg during the last month&#xD;
      </textblock>
    </criteria>
    <gender>Female</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>Luc TAPPY, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Physiology, University of Lausanne, Switzerland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Lausanne</name>
      <address>
        <city>Lausanne</city>
        <zip>1005</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>December 28, 2017</last_update_submitted>
  <last_update_submitted_qc>December 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Lausanne</investigator_affiliation>
    <investigator_full_name>Luc Tappy, MD</investigator_full_name>
    <investigator_title>Full Professor</investigator_title>
  </responsible_party>
  <keyword>sweeteners</keyword>
  <keyword>sugar</keyword>
  <keyword>stress response</keyword>
  <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/NCT02973334
org study id: 316/15
nct id: NCT02973334
lead sponsor: 
has dmc: No
This exploratory study aims at investigating the acute effects of artificially sweetened and
      sugar beverage consumption (as compared to water consumption) on acute hemodynamic and
      metabolic stress response.
This single-center study included five visits. The first two visits (screening and
      familiarization) allowed checking the eligibility of the volunteers. In case of inclusion,
      the subjects were assigned to a sequence of three experimental conditions (water, sugar and
      artificial sweeteners), in a randomized, crossover design.

      The experimental test was divided into 5 stages:

        1. a 90 minutes baseline period (t=0-90 min),

        2. a 30-min mental stress (MS; t=90-120 min), consisting in 5-min periods of Stroop's color
           word conflict test alternated with 5-min periods of mental arithmetic test.

        3. a 30-min MS recovery period (t=120-150),

        4. a 3-min cold pressure test (CPT) was carried out, aiming at immersing one volunteer's
           forearm in an ice water container at 3°C,

      3) a 15-min CPT recovery period (t=120-150). 60 min after the beginning of the metabolic
      test, volunteers will drink 25 mL every 15 min, after 10-sec mouth rinsing, of either an
      artificially- or sugar-sweetened beverages or water (control).

      Hemodynamic stress responses will be measured by repeated blood pressure, heart rate and
      cardiac output. Repeated venous blood samples will allow to assess metabolic stress
      responses.

      Each condition (water, artificial sweeteners and sugar) will be preceded by a 2-day run-in
      period.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Triple (Participant, Care Provider, Investigator)
measure: Hemodynamic changes
time frame: Differences observed between 90-min baseline and stress (30-min mental stress and 3-min cold pressure test)
description: Hemodynamic changes elicited by stress will be assessed by means of systemic vascular resistance calculated as (blood flow):(mean arterial pressure, and expressed in arbitrary units
measure: Changes in concentration of blood glucose
time frame: Blood samples will be collected 30, 60, 75, 85, 95, 100, 110, 120, 125, 135, 145, 153, 158, and 163 minutes after the beginning of the test
description: Blood glucose concentration will be measured in fasting conditions and during stress tests with the glucose oxidase method and expressed in mg/dl
measure: Changes in concentration of blood insulin
time frame: Blood samples will be collected 30, 60, 75, 85, 95, 100, 110, 120, 125, 135, 145, 153, 158, and 163 minutes after the beginning of the test
description: Blood insulin concentration will be measured by ELISA and expressed in mU/L
measure: Changes in blood non-esterified fatty acid concentration
time frame: Blood samples will be collected 30, 60, 75, 85, 95, 100, 110, 120, 125, 135, 145, 153, 158, and 163 minutes after the beginning of the tes
description: Blood non-esterified fatty acid concentration will be measured by a colorimetric method and expressed in mmol/L
measure: Metabolic changes
time frame: Differences observed between 90-min baseline and stress (30-min mental stress and 3-min cold pressure test)
description: Metabolic changes elicited by stress will be continually monitored from respiratory gas exchanges by indirect calorimetry.
arm group label: Sugar
arm group type: Experimental
description: Effects of ingestion of sugar-sweetened beverages on acute stress response
arm group label: Artificial sweetener
arm group type: Experimental
description: Effects of ingestion of artificially-sweetened beverages on acute stress response
arm group label: Water
arm group type: Active Comparator
description: Effects of ingestion of water on acute stress response
intervention type: Other
intervention name: Ingestion of artificially-sweetened beverages
description: From t=60 to the end of the metabolic test, volunteers will ingest 7 beverages containing non nutritive sweeteners (25 mL / beverage) every 15 minutes after 10-sec mouth rinsing.
arm group label: Artificial sweetener
intervention type: Other
intervention name: Ingestion of sugar-sweetened beverages
description: From t=60 to the end of the metabolic test, volunteers will ingest 7 beverages containing sugar (25 mL / beverage) every 15 minutes after 10-sec mouth rinsing.
arm group label: Sugar
intervention type: Other
intervention name: Ingestion of water
description: From t=60 to the end of the metabolic test, volunteers will ingest 7 water beverages (25 mL / beverage) every 15 minutes after 10-sec mouth rinsing.
arm group label: Water
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Luc TAPPY, Professor
role: Principal Investigator
affiliation: Department of Physiology, University of Lausanne, Switzerland
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: University of Lausanne
investigator full name: Luc Tappy, MD
investigator title: Full Professor
sharing ipd: No