<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/NCT04483180</url>
  </required_header>
  <id_info>
    <org_study_id>774293-WP2-P1</org_study_id>
    <nct_id>NCT04483180</nct_id>
  </id_info>
  <brief_title>Work Package 2 Phase 1 - Beverages Study</brief_title>
  <acronym>SWEET-WP2-P1</acronym>
  <official_title>Sweeteners and Sweetness Enhancers: Short-term Impact on Food Behaviour, Physiology &amp; Health (Phase 1)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinica Universidad de Navarra, Universidad de Navarra</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Leeds</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Copenhagen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Liverpool</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Surrey</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bioiatriki HEALTHCARE GROUP</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Clinica Universidad de Navarra, Universidad de Navarra</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Within the SWEET project (EU funded), in Work Package 2 there are two phases, this study&#xD;
      refers to Phase 1 of the SWEET WP2 project, which will be a coordinated trial across 3&#xD;
      intervention centres, University of Navarra (UNAV), University of Liverpool (ULIV) and&#xD;
      University of Copenhagen (UCPH). It will involve an acute intervention in 120 individuals to&#xD;
      explore initial acceptance, safety and post-prandial effects of 3 S&amp;SE blends delivered in&#xD;
      beverage format.&#xD;
&#xD;
      The main endpoints of the SWEET WP2 Phase 1 study will be glycaemic and lipaemic responses;&#xD;
      eating behavior (subjective appetite, food preference, cravings, reward), and health effects&#xD;
      (rebound hunger, G.I. side effects and metabolic effects). This phase will be exploratory and&#xD;
      will not involve any specific primary hypotheses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This protocol has the overall objective to evaluate the acute (short-term, 1 day) and&#xD;
      repeated (medium-term, 2 week) effects of combinations of sweeteners and sweetness enhancers&#xD;
      (S&amp;SEs) on metabolic, sensory and neuro-behavioural processes involved in satiety, consumer&#xD;
      preference and health, and to explore mechanistic processes, genetic background, safety&#xD;
      issues and consumer perspectives.&#xD;
&#xD;
      There are 4 products being tested in 4 different formulations (sucrose-sweetened beverage&#xD;
      control vs. 3 reformulated beverages with S&amp;SE). Each product will be tested at 3&#xD;
      intervention sites in double-blind cross-over trials with 40 subjects per site, tested per&#xD;
      product. Therefore a total of 120 subjects will take part across the 3 intervention sites&#xD;
      (UNAV, ULIV, UCPH).&#xD;
&#xD;
      Using identical procedures each trial will consist of 4 Clinical Investigation Days (CIDs)&#xD;
      scheduled 7-11 days apart for each of the 3 product formulations.&#xD;
&#xD;
      The total duration of WP2 Phase 2 per site is 6 months, including a minimum of 22 days and a&#xD;
      maximum of 34 days for each participant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 14, 2020</start_date>
  <completion_date type="Actual">June 30, 2021</completion_date>
  <primary_completion_date type="Actual">June 30, 2021</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>Multi-centre crossover study with 4 conditions using balanced block randomisation. The three centres will follow different randomisation sequences but will all test the same 4 conditions (University of Navarra, University of Copenhagen, University of Liverpool).</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Double blind study. Neither the participant nor the investigator will be aware of the coding of beverages used in the study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Blood glucose area under the curve (AUC)</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Area Under the Curve (AUC) for blood glucose (120 min post-intake)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood Insulin AUC</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Area Under the Curve for blood Insulin (120 min post-intake)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hunger iAUC</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Incremental Area Under the Curve for hunger (120 min post-intake)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fasting Blood glucose</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Fasting blood glucose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>30 min Blood glucose</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Blood glucose at 30 min post-intake</description>
  </primary_outcome>
  <primary_outcome>
    <measure>60 min Blood glucose</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Blood glucose at 60 min post-intake</description>
  </primary_outcome>
  <primary_outcome>
    <measure>90 min Blood glucose</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Blood glucose at 90 min post-intake</description>
  </primary_outcome>
  <primary_outcome>
    <measure>120 min Blood glucose</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Blood glucose at 120 min post-intake</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fasting Blood insulin</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Fasting blood insulin</description>
  </primary_outcome>
  <primary_outcome>
    <measure>30 min Blood insulin</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Blood insulin at 30 min post-intake</description>
  </primary_outcome>
  <primary_outcome>
    <measure>60 min Blood insulin</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Blood insulin at 60 min post-intake</description>
  </primary_outcome>
  <primary_outcome>
    <measure>90 min Blood insulin</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Blood insulin at 90 min post-intake</description>
  </primary_outcome>
  <primary_outcome>
    <measure>120 min Blood insulin</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Blood insulin at 120 min post-intake</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fasting Hunger (VAS registered)</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Fasting subjective appetite questionnaire. Visual Analogue Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>5 min Hunger (VAS registered)</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Subjective appetite questionnaire. Visual Analogue Scale at 5 min post-intake</description>
  </primary_outcome>
  <primary_outcome>
    <measure>15 min Hunger (VAS registered)</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Subjective appetite questionnaire. Visual Analogue Scale at 15 min post-intake</description>
  </primary_outcome>
  <primary_outcome>
    <measure>30 min Hunger (VAS registered)</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Subjective appetite questionnaire. Visual Analogue Scale at 30 min post-intake</description>
  </primary_outcome>
  <primary_outcome>
    <measure>45 min Hunger (VAS registered)</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Subjective appetite questionnaire. Visual Analogue Scale at 45 min post-intake</description>
  </primary_outcome>
  <primary_outcome>
    <measure>60 min Hunger (VAS registered)</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Subjective appetite questionnaire. Visual Analogue Scale at 60 min post-intake</description>
  </primary_outcome>
  <primary_outcome>
    <measure>120 min Hunger (VAS registered)</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Subjective appetite questionnaire. Visual Analogue Scale at 120 min post-intake</description>
  </primary_outcome>
  <primary_outcome>
    <measure>180 min Hunger (VAS registered)</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Subjective appetite questionnaire. Visual Analogue Scale at 180 min post-intake</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fasting Blood cholesterol</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Fasting blood cholesterol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30 min Blood cholesterol</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Blood cholesterol at 30 min post-intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>60 min Blood cholesterol</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Blood cholesterol at 60 min post-intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>90 min Blood cholesterol</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Blood cholesterol at 90 min post-intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>120 min Blood cholesterol</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Blood cholesterol at 120 min post-intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting Triglycerides</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Fasting triglycerides in serum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30 min Triglycerides</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Triglycerides in serum at 30 min post-intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>60 min Triglycerides</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Triglycerides in serum at 60 min post-intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>90 min Triglycerides</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Triglycerides in serum at 90 min post-intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>120 min Triglycerides</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Triglycerides in serum at 120 in post-intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting HDL-cholesterol</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Fasting HDL-cholesterol in serum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30 min HDL-cholesterol</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>HDL-cholesterol in serum at 30 min post-intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>60 min HDL-cholesterol</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>HDL-cholesterol in serum at 60 min post-intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>90 min HDL-cholesterol</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>HDL-cholesterol in serum at 90 min post-intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>120 min HDL-cholesterol</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>HDL-cholesterol in serum at 120 min post-intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting LDL-cholesterol</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Fasting LDL-cholesterol in serum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30 min LDL-cholesterol</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>LDL-cholesterol in serum at 30 min post-intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>60 min LDL-cholesterol</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>LDL-cholesterol in serum at 60 min post-intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>90 min LDL-cholesterol</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>LDL-cholesterol in serum at 90 min post-intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>120 min LDL-cholesterol</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>LDL-cholesterol in serum at 120 min post-intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting Alanine aminotransferase (ALT)</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Fasting liver function marker ALT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>120 min Alanine aminotransferase (ALT)</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Liver function marker ALT at 120 min post-intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting Aspartate aminotransferase (AST)</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Fasting liver function marker AST</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>120 min Aspartate aminotransferase (AST)</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Liver function marker AST at 120 min post-intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>Visit 0 (screening), Clinical Investigation Day 4</time_frame>
    <description>Anthropometry marker</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>Visit 0 (screening)</time_frame>
    <description>Anthropometry marker</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index (BMI)</measure>
    <time_frame>Visit 0 (screening), Clinical Investigation Day 4</time_frame>
    <description>Anthropometry marker</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist Circumference (WC)</measure>
    <time_frame>Visit 0 (screening)</time_frame>
    <description>Anthropometry marker</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hip Circumference (HC)</measure>
    <time_frame>Visit 0 (screening)</time_frame>
    <description>Anthropometry marker</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist-to-hip ratio (WHR)</measure>
    <time_frame>Visit 0 (screening)</time_frame>
    <description>Anthropometry marker</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leeds Food Preference Questionnaire (LFPQ)</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Change in food preference and food reward at 15-20 min post-intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Liking (VAS registered)</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Liking and explicit wanting of the beverage at 5 min post-intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting FG21</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Fasting FG21 concentration in serum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30 min FG21</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>FG21 concentration in serum at 30 min post-intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>60 min FG21</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>FG21 concentration in serum at 60 min post-intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>90 min FG21</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>FG21 concentration in serum at 90 min post-intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>120 min FG21</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>FG21 concentration in serum at 120 min post-intake</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Consumers' Perspectives Questionnaire</measure>
    <time_frame>Visit 0 (screening)</time_frame>
    <description>Psychological health drivers (perceptions)</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood DNA Analysis</measure>
    <time_frame>Clinical Investigation Day 1</time_frame>
    <description>DNA analysis for genetic polymorphism presence</description>
  </other_outcome>
  <other_outcome>
    <measure>24 hour food recall</measure>
    <time_frame>Next day after each clinical investigation day (1, 2, 3, 4)</time_frame>
    <description>Interview to know what the volunteers ate during the 24h following the beverage intake</description>
  </other_outcome>
  <other_outcome>
    <measure>24 hour Gastro Intestinal side effects</measure>
    <time_frame>Next day after each clinical investigation day (1, 2, 3, 4)</time_frame>
    <description>Interview to know if the volunteers experienced side effects during the 24h following the beverage intake</description>
  </other_outcome>
  <other_outcome>
    <measure>End of day questionnaire (VAS registered)</measure>
    <time_frame>Clinical Investigation Day 1, 2, 3, 4</time_frame>
    <description>Food cravings during the 8 h following the beverage intake</description>
  </other_outcome>
  <other_outcome>
    <measure>Risk factors for chronic disease</measure>
    <time_frame>Visit 0 (screening)</time_frame>
    <description>Baseline weight, height, BMI, WC and WHR, physical activity</description>
  </other_outcome>
  <other_outcome>
    <measure>Socio-demographic questionnaire</measure>
    <time_frame>Visit 0 (screening)</time_frame>
    <description>Ethnicity, household and employment</description>
  </other_outcome>
  <other_outcome>
    <measure>Eating Attitudes Test-26 (EAT-26)</measure>
    <time_frame>Visit 0 (screening)</time_frame>
    <description>Eating behaviour traits</description>
  </other_outcome>
  <other_outcome>
    <measure>Short sugar Food Frequency Questionnaire (short sFFQ)</measure>
    <time_frame>Visit 0 (screening)</time_frame>
    <description>Habitual intake of sweet foods</description>
  </other_outcome>
  <other_outcome>
    <measure>End of study survey</measure>
    <time_frame>Clinical Investigation Day 4</time_frame>
    <description>Perception and evaluation of the clinical trial</description>
  </other_outcome>
  <other_outcome>
    <measure>Taste test (VAS registered)</measure>
    <time_frame>Visit 0 (screening)</time_frame>
    <description>Liking of the study beverage</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">69</enrollment>
  <condition>Glycemic Index</condition>
  <condition>Overweight and Obesity</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Beverage containing a sucrose solution. Same aspect and flavor than the experimental beverages. About 1/4 of participants will start with this beverage first.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sucralose / acesulfame K</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Beverage containing a blend of sweeteners based on sucralose and acesulfame K. Same aspect and flavour than the control beverage. About 1/4 of participants will start with this beverage first.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stevia rebaudioside A / thaumatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Beverage containing a blend of sweeteners based on stevia rebaudioside A and thaumatin. Same aspect and flavour than the control beverage. About 1/4 of participants will start with this beverage first.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mogroside V / stevia rebaudioside M</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Beverage containing a blend of sweeteners based on mogroside V and stevia rebaudioside M. Same aspect and flavour than the control beverage. About 1/4 of participants will start with this beverage first.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Comparison of sweetener blends in liquid form (cross-over study)</intervention_name>
    <description>The aim is to compare the effects of different sweetener blends on glycemia, subjective appetite parameters and safety parameters when consumed in a beverage as part of a breakfast</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Mogroside V / stevia rebaudioside M</arm_group_label>
    <arm_group_label>Stevia rebaudioside A / thaumatin</arm_group_label>
    <arm_group_label>Sucralose / acesulfame K</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 18-60 years.&#xD;
&#xD;
          -  BMI: 25 to 35 kg/m2.&#xD;
&#xD;
          -  For women: Use of contraceptive methods or not planning to become pregnant for the&#xD;
             duration of the study.&#xD;
&#xD;
          -  Regular consumption of sugar-containing foods and willing to consume&#xD;
             artificially-sweetened beverages (a score of ≥ 5 on the short sFFQ Part 1a and answer&#xD;
             Yes to all questions in Part 2).&#xD;
&#xD;
          -  Able to participate on the visit days/CIDs during normal working hours.&#xD;
&#xD;
          -  Healthy as determined from the self-reported medical history or when a clinical&#xD;
             condition exists, when this is considered to be irrelevant (i.e. not influencing study&#xD;
             outcomes) for the study by the study medical doctor.&#xD;
&#xD;
          -  Consuming breakfast regularly (at least 5 days per week).&#xD;
&#xD;
          -  Liking of the study foods defined by a response of Yes for each of the breakfast foods&#xD;
             during the pre-screening interview and a score of 40 % or above on the Liking VAS for&#xD;
             the control beverage.&#xD;
&#xD;
          -  Able to understand and be willing to sign the informed consent form, and to follow all&#xD;
             the study procedures and requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Blood donation &lt; 3 month prior to study.&#xD;
&#xD;
          -  Deficient nutrition or hydration status as identified from the pre-screening/screening&#xD;
             session (i.e. absence of disease including anaemia, BMI &gt;18 kg/m2, or other criteria&#xD;
             as determined by the study doctor).&#xD;
&#xD;
          -  Food allergy, intolerance, restriction or avoidance of any of the study foods (e.g.&#xD;
             veganism) or history of anaphylactic reaction to any food.&#xD;
&#xD;
          -  Likelihood for disordered eating defined as a score of 20 or more on the EAT-26 test.&#xD;
&#xD;
          -  Currently dieting to lose weight or having been on weight cycles (i.e. repeatedly lost&#xD;
             and re-gained weight) in the last 3 months.&#xD;
&#xD;
          -  Smoking.&#xD;
&#xD;
          -  Binge drinking i.e. consuming &gt;14 units of alcohol per week in women or &gt;21 units/week&#xD;
             in men less than 4 days apart.&#xD;
&#xD;
          -  Performing &gt;10 h of intense physical activity per week.&#xD;
&#xD;
          -  Continuous night or late shift work (ending later than 11 pm on a permanent basis).&#xD;
             Rotational shift work allowed if can attend on days that do not follow a late/night&#xD;
             shift.&#xD;
&#xD;
          -  Self-reported use of drugs of abuse within the previous 12 months.&#xD;
&#xD;
          -  For women: Pregnancy, lactation.&#xD;
&#xD;
          -  Persons who do not have access to either (mobile) phone or internet (this is necessary&#xD;
             when being contacted by the study personnel during the study).&#xD;
&#xD;
          -  Insufficient communication in the national language.&#xD;
&#xD;
          -  Proven or suspected inability, physically or mentally, to comply with the procedures&#xD;
             required by the study protocol as evaluated by the daily study manager, site-PI, PI or&#xD;
             clinical responsible. This includes volunteers for which insufficient collaboration&#xD;
             may be foreseen.&#xD;
&#xD;
          -  Subject's general condition contraindicates continuing in the study as evaluated by&#xD;
             the daily study manager, site-PI, PI or clinical responsible.&#xD;
&#xD;
          -  Simultaneous participation in other relevant clinical intervention studies.&#xD;
&#xD;
          -  Previous university or college training related to eating behaviour research.&#xD;
&#xD;
          -  Medical conditions as known by the person:&#xD;
&#xD;
               -  Self-reported eating disorders.&#xD;
&#xD;
               -  Diagnosed anaemia.&#xD;
&#xD;
               -  Diagnosed diabetes mellitus.&#xD;
&#xD;
               -  Abnormal gastro-intestinal (G.I) function or structure such as malformation,&#xD;
                  angiodysplasia, active peptic ulcer.&#xD;
&#xD;
               -  Active inflammatory bowel disease, celiac disease, chronic pancreatitis or other&#xD;
                  disorder potentially causing malabsorption.&#xD;
&#xD;
               -  History of G.I. surgery with permanent effect (i.e. surgical treatment of&#xD;
                  obesity).&#xD;
&#xD;
               -  Medical history of cardio-vascular disease (e.g. current angina; myocardial&#xD;
                  infarction or stroke within the past 6 months; heart failure; symptomatic&#xD;
                  peripheral vascular disease).&#xD;
&#xD;
               -  Significant liver disease, e.g. cirrhosis (fatty liver disease allowed).&#xD;
&#xD;
               -  Malignancy which is currently active or in remission for less than five years&#xD;
                  after last treatment (local basal and squamous cell skin cancer allowed).&#xD;
&#xD;
               -  Thyroid diseases, except those on Levothyroxine treatment of hypothyroidism if&#xD;
                  the person has been on a stable dose for at least 3 months.&#xD;
&#xD;
               -  Psychiatric illness (e.g. major depression, bipolar disorders).&#xD;
&#xD;
          -  Medication:&#xD;
&#xD;
               -  Use currently or within the previous 3 months of prescription or over the counter&#xD;
                  medication that has the potential of affecting appetite, satiety or body weight&#xD;
                  incl. food supplements.&#xD;
&#xD;
        Except: low dose antidepressants if they, in the judgement of the daily study manager,&#xD;
        site-PI, PI or clinical responsible, do not affect weight or following the study protocol.&#xD;
        Levothyroxine for treatment of hypothyroidism is allowed if the person has been on a stable&#xD;
        dose for at least 3 months.&#xD;
&#xD;
        • Cholesterol lowering medication, if the dose has changed during the last 3 months (i.e.&#xD;
        the medication is allowed if the participant has been on a stable dose for at least 3&#xD;
        months).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Copenhagen</name>
      <address>
        <city>Frederiksberg</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre for Nutrition Research, University of Navarra</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Liverpool</name>
      <address>
        <city>Liverpool</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
    <country>Spain</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>August 17, 2022</last_update_submitted>
  <last_update_submitted_qc>August 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_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/NCT04483180
org study id: 774293-WP2-P1
nct id: NCT04483180
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Within the SWEET project (EU funded), in Work Package 2 there are two phases, this study
      refers to Phase 1 of the SWEET WP2 project, which will be a coordinated trial across 3
      intervention centres, University of Navarra (UNAV), University of Liverpool (ULIV) and
      University of Copenhagen (UCPH). It will involve an acute intervention in 120 individuals to
      explore initial acceptance, safety and post-prandial effects of 3 S&SE blends delivered in
      beverage format.

      The main endpoints of the SWEET WP2 Phase 1 study will be glycaemic and lipaemic responses;
      eating behavior (subjective appetite, food preference, cravings, reward), and health effects
      (rebound hunger, G.I. side effects and metabolic effects). This phase will be exploratory and
      will not involve any specific primary hypotheses.
This protocol has the overall objective to evaluate the acute (short-term, 1 day) and
      repeated (medium-term, 2 week) effects of combinations of sweeteners and sweetness enhancers
      (S&SEs) on metabolic, sensory and neuro-behavioural processes involved in satiety, consumer
      preference and health, and to explore mechanistic processes, genetic background, safety
      issues and consumer perspectives.

      There are 4 products being tested in 4 different formulations (sucrose-sweetened beverage
      control vs. 3 reformulated beverages with S&SE). Each product will be tested at 3
      intervention sites in double-blind cross-over trials with 40 subjects per site, tested per
      product. Therefore a total of 120 subjects will take part across the 3 intervention sites
      (UNAV, ULIV, UCPH).

      Using identical procedures each trial will consist of 4 Clinical Investigation Days (CIDs)
      scheduled 7-11 days apart for each of the 3 product formulations.

      The total duration of WP2 Phase 2 per site is 6 months, including a minimum of 22 days and a
      maximum of 34 days for each participant.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Multi-centre crossover study with 4 conditions using balanced block randomisation. The three centres will follow different randomisation sequences but will all test the same 4 conditions (University of Navarra, University of Copenhagen, University of Liverpool).
primary purpose: Screening
masking: Double (Participant, Investigator)
masking description: Double blind study. Neither the participant nor the investigator will be aware of the coding of beverages used in the study.
measure: Blood glucose area under the curve (AUC)
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Area Under the Curve (AUC) for blood glucose (120 min post-intake)
measure: Blood Insulin AUC
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Area Under the Curve for blood Insulin (120 min post-intake)
measure: Hunger iAUC
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Incremental Area Under the Curve for hunger (120 min post-intake)
measure: Fasting Blood glucose
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Fasting blood glucose
measure: 30 min Blood glucose
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Blood glucose at 30 min post-intake
measure: 60 min Blood glucose
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Blood glucose at 60 min post-intake
measure: 90 min Blood glucose
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Blood glucose at 90 min post-intake
measure: 120 min Blood glucose
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Blood glucose at 120 min post-intake
measure: Fasting Blood insulin
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Fasting blood insulin
measure: 30 min Blood insulin
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Blood insulin at 30 min post-intake
measure: 60 min Blood insulin
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Blood insulin at 60 min post-intake
measure: 90 min Blood insulin
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Blood insulin at 90 min post-intake
measure: 120 min Blood insulin
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Blood insulin at 120 min post-intake
measure: Fasting Hunger (VAS registered)
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Fasting subjective appetite questionnaire. Visual Analogue Scale
measure: 5 min Hunger (VAS registered)
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Subjective appetite questionnaire. Visual Analogue Scale at 5 min post-intake
measure: 15 min Hunger (VAS registered)
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Subjective appetite questionnaire. Visual Analogue Scale at 15 min post-intake
measure: 30 min Hunger (VAS registered)
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Subjective appetite questionnaire. Visual Analogue Scale at 30 min post-intake
measure: 45 min Hunger (VAS registered)
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Subjective appetite questionnaire. Visual Analogue Scale at 45 min post-intake
measure: 60 min Hunger (VAS registered)
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Subjective appetite questionnaire. Visual Analogue Scale at 60 min post-intake
measure: 120 min Hunger (VAS registered)
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Subjective appetite questionnaire. Visual Analogue Scale at 120 min post-intake
measure: 180 min Hunger (VAS registered)
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Subjective appetite questionnaire. Visual Analogue Scale at 180 min post-intake
measure: Fasting Blood cholesterol
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Fasting blood cholesterol
measure: 30 min Blood cholesterol
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Blood cholesterol at 30 min post-intake
measure: 60 min Blood cholesterol
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Blood cholesterol at 60 min post-intake
measure: 90 min Blood cholesterol
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Blood cholesterol at 90 min post-intake
measure: 120 min Blood cholesterol
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Blood cholesterol at 120 min post-intake
measure: Fasting Triglycerides
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Fasting triglycerides in serum
measure: 30 min Triglycerides
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Triglycerides in serum at 30 min post-intake
measure: 60 min Triglycerides
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Triglycerides in serum at 60 min post-intake
measure: 90 min Triglycerides
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Triglycerides in serum at 90 min post-intake
measure: 120 min Triglycerides
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Triglycerides in serum at 120 in post-intake
measure: Fasting HDL-cholesterol
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Fasting HDL-cholesterol in serum
measure: 30 min HDL-cholesterol
time frame: Clinical Investigation Day 1, 2, 3, 4
description: HDL-cholesterol in serum at 30 min post-intake
measure: 60 min HDL-cholesterol
time frame: Clinical Investigation Day 1, 2, 3, 4
description: HDL-cholesterol in serum at 60 min post-intake
measure: 90 min HDL-cholesterol
time frame: Clinical Investigation Day 1, 2, 3, 4
description: HDL-cholesterol in serum at 90 min post-intake
measure: 120 min HDL-cholesterol
time frame: Clinical Investigation Day 1, 2, 3, 4
description: HDL-cholesterol in serum at 120 min post-intake
measure: Fasting LDL-cholesterol
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Fasting LDL-cholesterol in serum
measure: 30 min LDL-cholesterol
time frame: Clinical Investigation Day 1, 2, 3, 4
description: LDL-cholesterol in serum at 30 min post-intake
measure: 60 min LDL-cholesterol
time frame: Clinical Investigation Day 1, 2, 3, 4
description: LDL-cholesterol in serum at 60 min post-intake
measure: 90 min LDL-cholesterol
time frame: Clinical Investigation Day 1, 2, 3, 4
description: LDL-cholesterol in serum at 90 min post-intake
measure: 120 min LDL-cholesterol
time frame: Clinical Investigation Day 1, 2, 3, 4
description: LDL-cholesterol in serum at 120 min post-intake
measure: Fasting Alanine aminotransferase (ALT)
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Fasting liver function marker ALT
measure: 120 min Alanine aminotransferase (ALT)
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Liver function marker ALT at 120 min post-intake
measure: Fasting Aspartate aminotransferase (AST)
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Fasting liver function marker AST
measure: 120 min Aspartate aminotransferase (AST)
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Liver function marker AST at 120 min post-intake
measure: Weight
time frame: Visit 0 (screening), Clinical Investigation Day 4
description: Anthropometry marker
measure: Height
time frame: Visit 0 (screening)
description: Anthropometry marker
measure: Body Mass Index (BMI)
time frame: Visit 0 (screening), Clinical Investigation Day 4
description: Anthropometry marker
measure: Waist Circumference (WC)
time frame: Visit 0 (screening)
description: Anthropometry marker
measure: Hip Circumference (HC)
time frame: Visit 0 (screening)
description: Anthropometry marker
measure: Waist-to-hip ratio (WHR)
time frame: Visit 0 (screening)
description: Anthropometry marker
measure: Leeds Food Preference Questionnaire (LFPQ)
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Change in food preference and food reward at 15-20 min post-intake
measure: Liking (VAS registered)
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Liking and explicit wanting of the beverage at 5 min post-intake
measure: Fasting FG21
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Fasting FG21 concentration in serum
measure: 30 min FG21
time frame: Clinical Investigation Day 1, 2, 3, 4
description: FG21 concentration in serum at 30 min post-intake
measure: 60 min FG21
time frame: Clinical Investigation Day 1, 2, 3, 4
description: FG21 concentration in serum at 60 min post-intake
measure: 90 min FG21
time frame: Clinical Investigation Day 1, 2, 3, 4
description: FG21 concentration in serum at 90 min post-intake
measure: 120 min FG21
time frame: Clinical Investigation Day 1, 2, 3, 4
description: FG21 concentration in serum at 120 min post-intake
measure: Consumers' Perspectives Questionnaire
time frame: Visit 0 (screening)
description: Psychological health drivers (perceptions)
measure: Blood DNA Analysis
time frame: Clinical Investigation Day 1
description: DNA analysis for genetic polymorphism presence
measure: 24 hour food recall
time frame: Next day after each clinical investigation day (1, 2, 3, 4)
description: Interview to know what the volunteers ate during the 24h following the beverage intake
measure: 24 hour Gastro Intestinal side effects
time frame: Next day after each clinical investigation day (1, 2, 3, 4)
description: Interview to know if the volunteers experienced side effects during the 24h following the beverage intake
measure: End of day questionnaire (VAS registered)
time frame: Clinical Investigation Day 1, 2, 3, 4
description: Food cravings during the 8 h following the beverage intake
measure: Risk factors for chronic disease
time frame: Visit 0 (screening)
description: Baseline weight, height, BMI, WC and WHR, physical activity
measure: Socio-demographic questionnaire
time frame: Visit 0 (screening)
description: Ethnicity, household and employment
measure: Eating Attitudes Test-26 (EAT-26)
time frame: Visit 0 (screening)
description: Eating behaviour traits
measure: Short sugar Food Frequency Questionnaire (short sFFQ)
time frame: Visit 0 (screening)
description: Habitual intake of sweet foods
measure: End of study survey
time frame: Clinical Investigation Day 4
description: Perception and evaluation of the clinical trial
measure: Taste test (VAS registered)
time frame: Visit 0 (screening)
description: Liking of the study beverage
arm group label: Control
arm group type: Placebo Comparator
description: Beverage containing a sucrose solution. Same aspect and flavor than the experimental beverages. About 1/4 of participants will start with this beverage first.
arm group label: Sucralose / acesulfame K
arm group type: Experimental
description: Beverage containing a blend of sweeteners based on sucralose and acesulfame K. Same aspect and flavour than the control beverage. About 1/4 of participants will start with this beverage first.
arm group label: Stevia rebaudioside A / thaumatin
arm group type: Experimental
description: Beverage containing a blend of sweeteners based on stevia rebaudioside A and thaumatin. Same aspect and flavour than the control beverage. About 1/4 of participants will start with this beverage first.
arm group label: Mogroside V / stevia rebaudioside M
arm group type: Experimental
description: Beverage containing a blend of sweeteners based on mogroside V and stevia rebaudioside M. Same aspect and flavour than the control beverage. About 1/4 of participants will start with this beverage first.
intervention type: Other
intervention name: Comparison of sweetener blends in liquid form (cross-over study)
description: The aim is to compare the effects of different sweetener blends on glycemia, subjective appetite parameters and safety parameters when consumed in a beverage as part of a breakfast
arm group label: Control
arm group label: Mogroside V / stevia rebaudioside M
arm group label: Stevia rebaudioside A / thaumatin
arm group label: Sucralose / acesulfame K
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
country: Denmark
country: Spain
country: United Kingdom
responsible party type: Sponsor
mesh term: Overweight
sharing ipd: Undecided