<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/NCT01720784</url>
  </required_header>
  <id_info>
    <org_study_id>H-3-2012-101</org_study_id>
    <secondary_id>B295</secondary_id>
    <nct_id>NCT01720784</nct_id>
  </id_info>
  <brief_title>Effect of Beverages Containing Different Doses of Alginate Fibers on Appetite, Energy Intake and Glycemia</brief_title>
  <acronym>ALSAT</acronym>
  <official_title>Effect of Beverages Containing Different Doses of Alginate Fibers on Appetite, Energy Intake and Glycemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Arne Astrup</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>S-Biotek Holding ApS</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Copenhagen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Studies report that dietary fiber intake is inversely correlated with body weight gain.&#xD;
      Previously, we have shown alginate fiber supplementation increases weight loss, which we&#xD;
      ascribe to its satiating effct.Alginate is a major plant dietary fiber in brown seaweed. One&#xD;
      property of importance to appetite is the ability of alginate to gel in the acidic&#xD;
      environment of the stomach. We hypothesize that the alginate will decrease the feeling of&#xD;
      hunger and lower food consumption compared to control.&#xD;
&#xD;
      Here we test three different beverages in a double-blinded crossover design, in which 24&#xD;
      participants will be randomly assigned to the sequence of the test days separated by at least&#xD;
      5 days.&#xD;
&#xD;
      On each test day appetite sensation as well as blood glucose and insulin will be measured&#xD;
      over 4h after intake of the test product. Hereafter, an ad libitum meal consisting of Pasta&#xD;
      Bolognese will be served, and energy intake calculated. The participants will also rate&#xD;
      gastrointestinal confort.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Three different iso-caloric beverages will be tested in a double-blinded crossover design, in&#xD;
      which 24 participants will be randomly assigned to the sequence of the test days separated by&#xD;
      at least 5 days. Prior to the test days, the participants will follow a standardized fasting&#xD;
      procedure: abstention from alcohol hard physical activity for 24 h; furthermore, consumption&#xD;
      of the same evening meal no later than 8 pm on the night before all meal tests, after which&#xD;
      time point they should be fasting. They are allowed 500 mL of water between 8 pm and the&#xD;
      morning of the test days.&#xD;
&#xD;
      On each test day, the participants will meet at the department in a fasting state. After&#xD;
      voiding they will be weighed, and a venflon catheter will be inserted in the antecubital&#xD;
      vein, allowing repeated blood sampling throughout the test day. Baseline measurements of&#xD;
      blood pressure, blood samples, and visual analogue scales (VAS) scores will be conducted at&#xD;
      time point of -15 min. A second baseline blood sample will be drawn at time point 0,&#xD;
      immediately after which the participants will consume the preload beverage (time point 0)&#xD;
      with a 10 min time limit for consumption. After consumption of the preload beverage, blood&#xD;
      samples will be taken and VAS scores completed at time points 15 and 30 min, and hereafter&#xD;
      the he standardized breakfast will be served for which 15 minutes is allowed (time point 30&#xD;
      min). After the participants have finished the breakfast, blood samples will be drawn and VAS&#xD;
      scores completed at time points 45, 60, 90, 120, 180, 210 and 240 min.&#xD;
&#xD;
      Hereafter, an ad libitum meal consisting of Pasta Bolognese will be served, and energy intake&#xD;
      calculated, and the final VAS score will be completed at time point 270 min after the&#xD;
      participants have finished their lunch. Before leaving, the participants will fill in a&#xD;
      questionnaire related to gastrointestinal adverse events (AE).&#xD;
&#xD;
      As a pilot study, the first 6 participants to finish the study will be invited to participate&#xD;
      in a fourth test day, on which capsules containing alginate fibers will be administered&#xD;
      together with the placebo beverage. This fourth test day is not included in the randomization&#xD;
      and will not be blinded for the participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Subjective appetite ratings including derivative measures</measure>
    <time_frame>Assessed 12 times over a 4hour period after each of three test meals served at least 5 days apart</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ad libitum food intake at the subsequent meal</measure>
    <time_frame>Assessed after 4 hours after each of three test meals served at least 5 days apart</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose and insulin response including derivative measures</measure>
    <time_frame>Assessed 12 times over a 4hour period after each of three test meals served at least 5 days apart</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Ratings of gastrointestinal discomfort during 24 hours following the test meals</measure>
    <time_frame>Assessed4 times over a 24 hour period after each of three test meals served at least 5 days apart</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Low dose (1.5 g DF)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>High dose (2.25 gDF)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Alginate dietary fiber</intervention_name>
    <arm_group_label>High dose (2.25 gDF)</arm_group_label>
    <arm_group_label>Low dose (1.5 g DF)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Overweight (BMI 25-35 kg/m2)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any food allergy, dislike or special diet of relevance to the study (e.g. vegetarian)&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Use of dietary supplements up to 1 month before the first meal test&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Daily use of prescription medication (except for oral contraceptives)&#xD;
&#xD;
          -  Any known chronic illnesses&#xD;
&#xD;
          -  Participation in other intervention studies&#xD;
&#xD;
          -  Non-adherence to the protocol or lack of cooperation&#xD;
&#xD;
          -  Blood donation within 3 months prior to the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Nutrition, Exercise and Sports, University of Copenhagen</name>
      <address>
        <city>Frederiksberg C</city>
        <zip>1958</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>November 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>September 1, 2014</last_update_submitted>
  <last_update_submitted_qc>September 1, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Copenhagen</investigator_affiliation>
    <investigator_full_name>Arne Astrup</investigator_full_name>
    <investigator_title>Head of Department</investigator_title>
  </responsible_party>
  <!-- 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/NCT01720784
org study id: H-3-2012-101
secondary id: B295
nct id: NCT01720784
lead sponsor: 
collaborator: 
has dmc: No
Studies report that dietary fiber intake is inversely correlated with body weight gain.
      Previously, we have shown alginate fiber supplementation increases weight loss, which we
      ascribe to its satiating effct.Alginate is a major plant dietary fiber in brown seaweed. One
      property of importance to appetite is the ability of alginate to gel in the acidic
      environment of the stomach. We hypothesize that the alginate will decrease the feeling of
      hunger and lower food consumption compared to control.

      Here we test three different beverages in a double-blinded crossover design, in which 24
      participants will be randomly assigned to the sequence of the test days separated by at least
      5 days.

      On each test day appetite sensation as well as blood glucose and insulin will be measured
      over 4h after intake of the test product. Hereafter, an ad libitum meal consisting of Pasta
      Bolognese will be served, and energy intake calculated. The participants will also rate
      gastrointestinal confort.
Three different iso-caloric beverages will be tested in a double-blinded crossover design, in
      which 24 participants will be randomly assigned to the sequence of the test days separated by
      at least 5 days. Prior to the test days, the participants will follow a standardized fasting
      procedure: abstention from alcohol hard physical activity for 24 h; furthermore, consumption
      of the same evening meal no later than 8 pm on the night before all meal tests, after which
      time point they should be fasting. They are allowed 500 mL of water between 8 pm and the
      morning of the test days.

      On each test day, the participants will meet at the department in a fasting state. After
      voiding they will be weighed, and a venflon catheter will be inserted in the antecubital
      vein, allowing repeated blood sampling throughout the test day. Baseline measurements of
      blood pressure, blood samples, and visual analogue scales (VAS) scores will be conducted at
      time point of -15 min. A second baseline blood sample will be drawn at time point 0,
      immediately after which the participants will consume the preload beverage (time point 0)
      with a 10 min time limit for consumption. After consumption of the preload beverage, blood
      samples will be taken and VAS scores completed at time points 15 and 30 min, and hereafter
      the he standardized breakfast will be served for which 15 minutes is allowed (time point 30
      min). After the participants have finished the breakfast, blood samples will be drawn and VAS
      scores completed at time points 45, 60, 90, 120, 180, 210 and 240 min.

      Hereafter, an ad libitum meal consisting of Pasta Bolognese will be served, and energy intake
      calculated, and the final VAS score will be completed at time point 270 min after the
      participants have finished their lunch. Before leaving, the participants will fill in a
      questionnaire related to gastrointestinal adverse events (AE).

      As a pilot study, the first 6 participants to finish the study will be invited to participate
      in a fourth test day, on which capsules containing alginate fibers will be administered
      together with the placebo beverage. This fourth test day is not included in the randomization
      and will not be blinded for the participants.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Subjective appetite ratings including derivative measures
time frame: Assessed 12 times over a 4hour period after each of three test meals served at least 5 days apart
measure: Ad libitum food intake at the subsequent meal
time frame: Assessed after 4 hours after each of three test meals served at least 5 days apart
measure: Glucose and insulin response including derivative measures
time frame: Assessed 12 times over a 4hour period after each of three test meals served at least 5 days apart
measure: Ratings of gastrointestinal discomfort during 24 hours following the test meals
time frame: Assessed4 times over a 24 hour period after each of three test meals served at least 5 days apart
arm group label: Placebo
arm group type: Placebo Comparator
arm group label: Low dose (1.5 g DF)
arm group type: Experimental
arm group label: High dose (2.25 gDF)
arm group type: Experimental
intervention type: Dietary Supplement
intervention name: Alginate dietary fiber
arm group label: High dose (2.25 gDF)
arm group label: Low dose (1.5 g DF)
intervention type: Dietary Supplement
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Denmark
responsible party type: Sponsor-Investigator
investigator affiliation: University of Copenhagen
investigator full name: Arne Astrup
investigator title: Head of Department