<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/NCT03806920</url>
  </required_header>
  <id_info>
    <org_study_id>PALA</org_study_id>
    <nct_id>NCT03806920</nct_id>
  </id_info>
  <brief_title>Isomaltulose VS Sucrose - Postprandial Effect on Incretin Profile and Second Meal Effect</brief_title>
  <official_title>Isomaltulose VS Sucrose - Different Postprandial Effect on Incretin Profile and Determinants of the Second Meal Effect</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>German Institute of Human Nutrition</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beneo GmbH</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>German Institute of Human Nutrition</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>
      This study evaluates the different postprandial effect of isomaltulose and sucrose on the&#xD;
      incretin profile and as an determinant for the second meal effect.&#xD;
&#xD;
      In this nutritional intervention study, healthy participants and T2DM patients ingest 2&#xD;
      standardized meals for breakfast and lunch in combination with either sucrose or palatinose&#xD;
      on 2 separate days. In addition, blood samples are taken to analyze markers of the&#xD;
      carbohydrate metabolism, incretins and specific inflammation markers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Isomaltulose is a natural occurring disaccharide with a similar structure to sucrose. It is&#xD;
      composed of glucose and fructose, but is linked by an α-1,6-glycosidic bond instead of α-1,2.&#xD;
      Due to its binding, isomaltulose is slowly hydrolysed, which results in a rather weak&#xD;
      postprandial glycemic-insulinemic response, accompanied by a minimal GIP secretion and a&#xD;
      stimulated secretion of GLP-1. In addition, several studies have shown that the intake of&#xD;
      foods with a low glycemic index, such as isomaltulose, tend to improve the metabolic reaction&#xD;
      to a subsequent meal. As the exact mechanism of this &quot;second meal effect&quot; is still unknown,&#xD;
      the investigators hypothesize that the modified release and action of GIP and GLP-1 are key&#xD;
      players in regard to the described effects.Therefore, isomaltulose could be a suitable tool&#xD;
      for reducing the risk of developing diabetes, obesity and CVD as well as improve blood&#xD;
      glucose control in people with diabetes.&#xD;
&#xD;
      In summary, this study evaluates the different postprandial effect of isomaltulose and&#xD;
      sucrose on the incretin profile and as a determinant for the second meal effect.&#xD;
&#xD;
      In this nutritional intervention study, healthy participants and T2DM patients ingest 2&#xD;
      standardized meals for breakfast and lunch in combination with either sucrose or palatinose&#xD;
      on 2 separated days. In addition, blood samples are taken to analyze markers of the&#xD;
      carbohydrate metabolism, incretins and specific inflammation markers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 5, 2016</start_date>
  <completion_date type="Actual">July 30, 2019</completion_date>
  <primary_completion_date type="Actual">September 30, 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>Comparison of sucrose vs. palatinose (isomaltulose) on second meal effect (high-GI meal vs. high-protein meal) in subjects with T2DM or metabolic Syndrome without T2DM</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>participants were unaware of selected sugar intake prior to second meal</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>disposition index</measure>
    <time_frame>4 visits, separated by 1 week each</time_frame>
    <description>Alteration of the Insulin secretion due to the intake of isomaltulose or sucrose in combination with different times and meal compositions. This should lead to an improved beta-cell response (Insulin secretion)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>insulinogenic index</measure>
    <time_frame>4 visits, separated by 1 week each</time_frame>
    <description>Alteration of the incretin profile due to the intake of isomaltulose or sucrose in combination with different times and meal compositions. This should lead to an improved second meal effect (Insulin sensitivity).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>hepatic insulin extraction</measure>
    <time_frame>4 visits, separated by 1 week each</time_frame>
    <description>Alteration of the incretin profile due to the intake of isomaltulose or sucrose in combination with different times and meal compositions. This should lead to an improved hepatic insulin extraction (secondary effect of improved Insulin sensitivity).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>incretin response</measure>
    <time_frame>4 visits, separated by 1 week each</time_frame>
    <description>Parameters: GIP, GLP-1, gastric emptying, Glucagon</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inflammatory reaction</measure>
    <time_frame>4 visits, separated by 1 week each</time_frame>
    <description>Parameters: IL8, IL-18</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipid status</measure>
    <time_frame>4 visits, separated by 1 week each</time_frame>
    <description>Parameters: NEFA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>additional endocrine parameters</measure>
    <time_frame>4 visits, separated by 1 week each</time_frame>
    <description>Parameters: FGF21</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>Intervention A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nutritional intervention in healthy subjects and T2DM subjects:&#xD;
Accompanying a carbohydrate based breakfast, participants ingest either 50 g sucrose followed by a standardized lunch on 1 single day. In addition, blood samples are taken over 8 hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nutritional intervention in healthy subjects and T2DM subjects:&#xD;
Accompanying a carbohydrate based breakfast, participants ingest either 50 g palatinose followed by a standardized lunch on 1 single day. In addition, blood samples are taken over 8 hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention C</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nutritional intervention in healthy subjects:&#xD;
Accompanying a protein-based breakfast, participants ingest either 50 g sucrose followed by a standardized lunch on 1 single day. In addition, blood samples are taken over 8 hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention D</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nutritional intervention in healthy subjects:&#xD;
Accompanying a protein-based breakfast, participants ingest either 50 g isomaltulose followed by a standardized lunch on 1 single day. In addition, blood samples are taken over 8 hours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Intervention A</intervention_name>
    <arm_group_label>Intervention A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Intervention B</intervention_name>
    <arm_group_label>Intervention B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Intervention C</intervention_name>
    <arm_group_label>Intervention C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Intervention D</intervention_name>
    <arm_group_label>Intervention D</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  for T2DM patients: insulin-independent&#xD;
&#xD;
          -  for healthy subjects: at least 1 component of the metabolic syndrom:&#xD;
&#xD;
               -  Body mass index (BMI) ≥ 30 kg/m²&#xD;
&#xD;
               -  Waist-hip ratio (WHR) ≥ 85 for women and ≥ 90 for men&#xD;
&#xD;
               -  hypertension&#xD;
&#xD;
               -  dyslipidemia&#xD;
&#xD;
               -  glucose / insulin intolerance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  medications: intake of medications which influence glucose metabolism&#xD;
&#xD;
          -  alcohol / drug abuse&#xD;
&#xD;
          -  physical diseases: endocrinological, malign, serious cardiovascular diseases&#xD;
&#xD;
          -  acute / chronic communicable disease&#xD;
&#xD;
          -  psychic diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>German Institute of Human Nutrition</name>
      <address>
        <city>Potsdam</city>
        <state>Brandenburg</state>
        <zip>14458</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>November 8, 2017</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>June 23, 2020</last_update_submitted>
  <last_update_submitted_qc>June 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>German Institute of Human Nutrition</investigator_affiliation>
    <investigator_full_name>Prof. Dr. med. Andreas F. H. Pfeiffer</investigator_full_name>
    <investigator_title>Director (Dpt. Clinical Nutrition)</investigator_title>
  </responsible_party>
  <keyword>Isomaltulose</keyword>
  <keyword>Palatinose</keyword>
  <keyword>second meal effect</keyword>
  <keyword>incretin</keyword>
  <keyword>GIP</keyword>
  <keyword>GLP-1</keyword>
  <keyword>postprandial inflammation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <!-- 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/NCT03806920
org study id: PALA
nct id: NCT03806920
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the different postprandial effect of isomaltulose and sucrose on the
      incretin profile and as an determinant for the second meal effect.

      In this nutritional intervention study, healthy participants and T2DM patients ingest 2
      standardized meals for breakfast and lunch in combination with either sucrose or palatinose
      on 2 separate days. In addition, blood samples are taken to analyze markers of the
      carbohydrate metabolism, incretins and specific inflammation markers.
Isomaltulose is a natural occurring disaccharide with a similar structure to sucrose. It is
      composed of glucose and fructose, but is linked by an α-1,6-glycosidic bond instead of α-1,2.
      Due to its binding, isomaltulose is slowly hydrolysed, which results in a rather weak
      postprandial glycemic-insulinemic response, accompanied by a minimal GIP secretion and a
      stimulated secretion of GLP-1. In addition, several studies have shown that the intake of
      foods with a low glycemic index, such as isomaltulose, tend to improve the metabolic reaction
      to a subsequent meal. As the exact mechanism of this "second meal effect" is still unknown,
      the investigators hypothesize that the modified release and action of GIP and GLP-1 are key
      players in regard to the described effects.Therefore, isomaltulose could be a suitable tool
      for reducing the risk of developing diabetes, obesity and CVD as well as improve blood
      glucose control in people with diabetes.

      In summary, this study evaluates the different postprandial effect of isomaltulose and
      sucrose on the incretin profile and as a determinant for the second meal effect.

      In this nutritional intervention study, healthy participants and T2DM patients ingest 2
      standardized meals for breakfast and lunch in combination with either sucrose or palatinose
      on 2 separated days. In addition, blood samples are taken to analyze markers of the
      carbohydrate metabolism, incretins and specific inflammation markers.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Comparison of sucrose vs. palatinose (isomaltulose) on second meal effect (high-GI meal vs. high-protein meal) in subjects with T2DM or metabolic Syndrome without T2DM
primary purpose: Prevention
masking: Single (Participant)
masking description: participants were unaware of selected sugar intake prior to second meal
measure: disposition index
time frame: 4 visits, separated by 1 week each
description: Alteration of the Insulin secretion due to the intake of isomaltulose or sucrose in combination with different times and meal compositions. This should lead to an improved beta-cell response (Insulin secretion)
measure: insulinogenic index
time frame: 4 visits, separated by 1 week each
description: Alteration of the incretin profile due to the intake of isomaltulose or sucrose in combination with different times and meal compositions. This should lead to an improved second meal effect (Insulin sensitivity).
measure: hepatic insulin extraction
time frame: 4 visits, separated by 1 week each
description: Alteration of the incretin profile due to the intake of isomaltulose or sucrose in combination with different times and meal compositions. This should lead to an improved hepatic insulin extraction (secondary effect of improved Insulin sensitivity).
measure: incretin response
time frame: 4 visits, separated by 1 week each
description: Parameters: GIP, GLP-1, gastric emptying, Glucagon
measure: inflammatory reaction
time frame: 4 visits, separated by 1 week each
description: Parameters: IL8, IL-18
measure: Lipid status
time frame: 4 visits, separated by 1 week each
description: Parameters: NEFA
measure: additional endocrine parameters
time frame: 4 visits, separated by 1 week each
description: Parameters: FGF21
arm group label: Intervention A
arm group type: Active Comparator
description: Nutritional intervention in healthy subjects and T2DM subjects:
Accompanying a carbohydrate based breakfast, participants ingest either 50 g sucrose followed by a standardized lunch on 1 single day. In addition, blood samples are taken over 8 hours.
arm group label: Intervention B
arm group type: Active Comparator
description: Nutritional intervention in healthy subjects and T2DM subjects:
Accompanying a carbohydrate based breakfast, participants ingest either 50 g palatinose followed by a standardized lunch on 1 single day. In addition, blood samples are taken over 8 hours.
arm group label: Intervention C
arm group type: Active Comparator
description: Nutritional intervention in healthy subjects:
Accompanying a protein-based breakfast, participants ingest either 50 g sucrose followed by a standardized lunch on 1 single day. In addition, blood samples are taken over 8 hours.
arm group label: Intervention D
arm group type: Active Comparator
description: Nutritional intervention in healthy subjects:
Accompanying a protein-based breakfast, participants ingest either 50 g isomaltulose followed by a standardized lunch on 1 single day. In addition, blood samples are taken over 8 hours.
intervention type: Dietary Supplement
intervention name: Intervention A
arm group label: Intervention A
intervention type: Dietary Supplement
intervention name: Intervention B
arm group label: Intervention B
intervention type: Dietary Supplement
intervention name: Intervention C
arm group label: Intervention C
intervention type: Dietary Supplement
intervention name: Intervention D
arm group label: Intervention D
criteria: 
gender: All
minimum age: 45 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: German Institute of Human Nutrition
investigator full name: Prof. Dr. med. Andreas F. H. Pfeiffer
investigator title: Director (Dpt. Clinical Nutrition)
mesh term: Metabolic Syndrome
mesh term: Diabetes Mellitus, Type 2