<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/NCT03232008</url>
  </required_header>
  <id_info>
    <org_study_id>KCLMScNutr2017</org_study_id>
    <nct_id>NCT03232008</nct_id>
  </id_info>
  <brief_title>Canderel:Effects on Blood Glucose Concentration and Appetite Scores</brief_title>
  <official_title>The Effects of Canderel (Aspartame and Acesulfame-k Blend) on Blood Glucose Concentration and Appetite Scores in Humans: a Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King's College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King's College London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study investigates the effects of Canderel, an aspartame and acesulfame-k blend&#xD;
      artificial sweetener powder, on post-postprandial blood glucose levels and appetite scores.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is separated into two parts: A) investigating the effects of artificial sweeteners&#xD;
      in combination with complex carbohydrates; and B) investigating the effects of artificial&#xD;
      sweeteners in combination with simple sugars.&#xD;
&#xD;
      A) Participants will be randomly given either the placebo drink (3g of maltodextrin dissolved&#xD;
      in 250ml of water) or the Canderel drink (3g of Canderel dissolved in 250ml of water)&#xD;
      alongside an isocaloric high carbohydrate breakfast. Blood glucose measurements will be&#xD;
      obtained through finger pricking and appetite will be measured using self-reported visual&#xD;
      analog scores rating hunger, desire to eat, fullness and alertness for up to 3 hours after&#xD;
      breakfast.&#xD;
&#xD;
      B)Participants will be randomly given either the placebo drink (3g of Lyle's Golden syrup and&#xD;
      3g of maltodextrin dissolved in 250ml of water) or the Canderel+sugars drink (3g of Canderel&#xD;
      and 3g of Lyle's Golden syrup dissolved in 250ml of water) . Blood glucose measurements will&#xD;
      be obtained through finger pricking and appetite will be measured using self-reported visual&#xD;
      analog scores rating hunger, desire to eat, fullness and alertness for up to 3 hours after&#xD;
      drink&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">September 1, 2015</start_date>
  <completion_date type="Anticipated">March 28, 2021</completion_date>
  <primary_completion_date type="Actual">February 28, 2019</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>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Blood glucose</measure>
    <time_frame>0-180min (Measured from baseline to 90min every 15min; 90-180min every 30min)</time_frame>
    <description>Capillary blood obtained from fingerprick and measured using glucose monitor</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Appetite</measure>
    <time_frame>0-180min (Measured from baseline to 90min every 15min; 90-180min every 30min)</time_frame>
    <description>Feelings of hunger, desire to eat, fullness and alertness measured using Visual Analog Scale (VAS)</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Appetitive Behavior</condition>
  <condition>Glucose Metabolism Disorders</condition>
  <arm_group>
    <arm_group_label>Experiment A- experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3g Canderel in 250ml water</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experiment A- control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>3g of maltodextrin in 250 ml of water</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experiment B- experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3g Canderel + 35g Lyle's Golden Syrup in 250 ml water</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experiment B- control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>3g Lyle's Golden Syrup + 35g of maltodextrin in 250 ml of water</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Canderel drink</intervention_name>
    <description>1.4% aspartame and 0.95% acesulfame-k and 95% maltodextrin; 3g dissolved in 250ml of water</description>
    <arm_group_label>Experiment A- experimental</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Canderel+Lyle's Golden Syrup drink</intervention_name>
    <description>Canderel: 1.4% aspartame and 0.95% acesulfame-k and 95% maltodextrin; 3g dissolved in 250ml of water Lyle's Golden Syrup: 35 g (27g of glucose and fructose)</description>
    <arm_group_label>Experiment B- experimental</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male and female adults (18-64)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr. Christopher Corpe</last_name>
    <role>Principal Investigator</role>
    <affiliation>King's College London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>King's College London</name>
      <address>
        <city>London</city>
        <zip>SE1 9NH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>June 19, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>September 21, 2020</last_update_submitted>
  <last_update_submitted_qc>September 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>King's College London</investigator_affiliation>
    <investigator_full_name>Dr Christopher Corpe</investigator_full_name>
    <investigator_title>Nutrition Sciences Lecturer, Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Blood glucose</keyword>
  <keyword>Appetite</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Diseases</mesh_term>
    <mesh_term>Glucose Metabolism Disorders</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/NCT03232008
org study id: KCLMScNutr2017
nct id: NCT03232008
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study investigates the effects of Canderel, an aspartame and acesulfame-k blend
      artificial sweetener powder, on post-postprandial blood glucose levels and appetite scores.
The study is separated into two parts: A) investigating the effects of artificial sweeteners
      in combination with complex carbohydrates; and B) investigating the effects of artificial
      sweeteners in combination with simple sugars.

      A) Participants will be randomly given either the placebo drink (3g of maltodextrin dissolved
      in 250ml of water) or the Canderel drink (3g of Canderel dissolved in 250ml of water)
      alongside an isocaloric high carbohydrate breakfast. Blood glucose measurements will be
      obtained through finger pricking and appetite will be measured using self-reported visual
      analog scores rating hunger, desire to eat, fullness and alertness for up to 3 hours after
      breakfast.

      B)Participants will be randomly given either the placebo drink (3g of Lyle's Golden syrup and
      3g of maltodextrin dissolved in 250ml of water) or the Canderel+sugars drink (3g of Canderel
      and 3g of Lyle's Golden syrup dissolved in 250ml of water) . Blood glucose measurements will
      be obtained through finger pricking and appetite will be measured using self-reported visual
      analog scores rating hunger, desire to eat, fullness and alertness for up to 3 hours after
      drink
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in Blood glucose
time frame: 0-180min (Measured from baseline to 90min every 15min; 90-180min every 30min)
description: Capillary blood obtained from fingerprick and measured using glucose monitor
measure: Change in Appetite
time frame: 0-180min (Measured from baseline to 90min every 15min; 90-180min every 30min)
description: Feelings of hunger, desire to eat, fullness and alertness measured using Visual Analog Scale (VAS)
arm group label: Experiment A- experimental
arm group type: Experimental
description: 3g Canderel in 250ml water
arm group label: Experiment A- control
arm group type: No Intervention
description: 3g of maltodextrin in 250 ml of water
arm group label: Experiment B- experimental
arm group type: Experimental
description: 3g Canderel + 35g Lyle's Golden Syrup in 250 ml water
arm group label: Experiment B- control
arm group type: No Intervention
description: 3g Lyle's Golden Syrup + 35g of maltodextrin in 250 ml of water
intervention type: Dietary Supplement
intervention name: Canderel drink
description: 1.4% aspartame and 0.95% acesulfame-k and 95% maltodextrin; 3g dissolved in 250ml of water
arm group label: Experiment A- experimental
intervention type: Dietary Supplement
intervention name: Canderel+Lyle's Golden Syrup drink
description: Canderel: 1.4% aspartame and 0.95% acesulfame-k and 95% maltodextrin; 3g dissolved in 250ml of water Lyle's Golden Syrup: 35 g (27g of glucose and fructose)
arm group label: Experiment B- experimental
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
last name: Dr. Christopher Corpe
role: Principal Investigator
affiliation: King's College London
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: King's College London
investigator full name: Dr Christopher Corpe
investigator title: Nutrition Sciences Lecturer, Principal investigator
mesh term: Metabolic Diseases
mesh term: Glucose Metabolism Disorders
sharing ipd: No