<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/NCT03293693</url>
  </required_header>
  <id_info>
    <org_study_id>2016/648</org_study_id>
    <nct_id>NCT03293693</nct_id>
  </id_info>
  <brief_title>Intake of Beta-glucan and Postprandial Regulation of Blood Glucose Metabolism in Healthy Subjects</brief_title>
  <official_title>Beta-glucan and Blood Glucose</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo Metropolitan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mills DA</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nofima</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Oslo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oslo Metropolitan University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall aim is to investigate the intake of beta-glucan in relation to glucose metabolism&#xD;
      and satiety in a postprandial study with healthy subjects. The potential effects will be&#xD;
      related to changes in the gut microbiota, the circulating levels of short chain fatty acids,&#xD;
      inflammation and gene expression in peripheral mononuclear blood cells&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The intervention study will have a fixed order, cross-over design with three test meals&#xD;
      containing low (0.5 g / 100 g of product), medium (3.5 g / 100 g of product) and high (8 g /&#xD;
      100 g product) amount of beta -glucans, respectively. The test meals are in the form of&#xD;
      cereals. All participants will eat the three test meals three constitutive days with 2 weeks&#xD;
      apart. At day four, the participants will perform a postprandial glucose test (OGTT, 75 g&#xD;
      glucose in 150 ml water) at Oslo and Akershus University College. Blood samples will be taken&#xD;
      before and at different time points after glucose test.&#xD;
&#xD;
      At the screening visit the participants will be asked to limit the intake of dietary fiber&#xD;
      from grains two weeks prior to the baseline visit (0) and during the study. Otherwise,&#xD;
      participants will be asked not to change their diet and exercise habits during the study&#xD;
      period.&#xD;
&#xD;
      At the baseline visit (visit 0) an OGTT will be performed. OGTT will also be performed at&#xD;
      visit 1, 3 and 5 after intake of low, medium and high beta-glucan, respectively.&#xD;
&#xD;
      The participants will receive the test meals at visit 1, 2 and 4.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Intervention With cross-over design. Three test meals will be tested.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postprandial blood glucose response</measure>
    <time_frame>At day 4</time_frame>
    <description>Blood glucose response after OGTT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postprandial insulin response</measure>
    <time_frame>At day 4</time_frame>
    <description>insulin response after OGTT</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>H2 breath response</measure>
    <time_frame>At day 4</time_frame>
    <description>H2 breath response after OGTT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Free fatty acids</measure>
    <time_frame>At day 4</time_frame>
    <description>Plasma free fatty acids are measured after intake of test meals</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microbiota analyses in feces</measure>
    <time_frame>At day 4</time_frame>
    <description>Microbiota analyses in feces are measured before and after intake of test meals. Change in microbiota will be analysed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum triglyceride response</measure>
    <time_frame>At day 4</time_frame>
    <description>Triglyceride response are measured are measured after OGTT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum cholesterol</measure>
    <time_frame>At day 4</time_frame>
    <description>Serum cholesterol are measured fasting after intake of test meals</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hunger and satiety hormones (e.g. GLP1)</measure>
    <time_frame>At day 4</time_frame>
    <description>The response in hunger and satiety hormones after OGTT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory markers (e.g. CRP)</measure>
    <time_frame>At day 4</time_frame>
    <description>Response in Inflammatory markers are measured after OGTT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mRNA analyses in PBMC (RT-PCR)</measure>
    <time_frame>At day 4</time_frame>
    <description>PBMC are collected before and after OGTT. The change in mRNA level will be analyzed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantitative assessment of metabolites in urine</measure>
    <time_frame>At day 4</time_frame>
    <description>Morning urine are collected before and after intake of test meals. Metabolites in urine will be quantified using UHPLC-qTOF-MS. Change in metabolites before and after test meals will be analyzed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantitative assessment of metabolites in plasma</measure>
    <time_frame>At day 4</time_frame>
    <description>Plasma for metabolome analyses are collected after intake of test meals. Metabolites in plasma will be quantified using UHPLC-qTOF-MS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual analogue scale (VAS)</measure>
    <time_frame>At day 1</time_frame>
    <description>Subjective hunger and satiety will be estimated after intake of test meals for one day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual analogue scale (VAS)</measure>
    <time_frame>At day 3</time_frame>
    <description>Subjective hunger and satiety will be estimated after intake of test meals for three days</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Post Prandial Blood Glucose</condition>
  <condition>Gut Microbiota</condition>
  <condition>Satiety</condition>
  <arm_group>
    <arm_group_label>Test meal 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test meal with 0.5 g beta-glucan</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test meal 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test meal with 3.5 g beta-glucan</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test meal 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test meal with 8 g beta-glucan</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>0.5 g beta-glucan</intervention_name>
    <description>Dietary cross-over study with beta-glucan fiber</description>
    <arm_group_label>Test meal 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>3.5 g beta-glucan</intervention_name>
    <description>Dietary cross-over study with beta-glucan fiber</description>
    <arm_group_label>Test meal 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>8 g beta-glucan</intervention_name>
    <description>Dietary cross-over study with beta-glucan fiber</description>
    <arm_group_label>Test meal 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI between 18,5 and 27 kg/m2&#xD;
&#xD;
          -  Fasting plasma glucose ≤ 6.1 mmol/l&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic metabolic diseases such as diabetes type 1 and 2, coronary heart disease and&#xD;
             cancer the last 6 months.&#xD;
&#xD;
          -  Intestinal diseases such as chrons disease, ulcerative colitis and irritable bowel&#xD;
             syndrome.&#xD;
&#xD;
          -  Food allergy and intolerances towards grain and dairy products.&#xD;
&#xD;
          -  Pregnant and lactating&#xD;
&#xD;
          -  Smokers&#xD;
&#xD;
          -  Fasting blood glucose ≥ 6.1 mmol/L&#xD;
&#xD;
          -  CRP &gt; 10 mg/L, measured at baseline (visit 0)&#xD;
&#xD;
          -  BMI &lt;18,5 and &gt;27 kg/m2&#xD;
&#xD;
          -  Planned weight reduction and or ± 5% weight change over the past three months.&#xD;
&#xD;
          -  Use of antibiotics last 3 months before study entry and during the study period&#xD;
&#xD;
          -  Use of probiotics the last month before study entry and during the study period&#xD;
&#xD;
          -  Blood donor last 2 months before study entry and or during the study period&#xD;
&#xD;
          -  Not willing to end the use of dietary supplements four weeks prior to study entry and&#xD;
             throughout the study period&#xD;
&#xD;
          -  Alcohol consumption &gt; 40g / day&#xD;
&#xD;
          -  Hormone treatments (except contraceptives)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mari CW Myhrstad, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oslo and Akershus university College</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oslo and Akershus university College</name>
      <address>
        <city>Oslo</city>
        <zip>0130</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>March 10, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>September 25, 2017</last_update_submitted>
  <last_update_submitted_qc>September 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>beta-glucan</keyword>
  <keyword>Blood glucose</keyword>
  <keyword>Gut microbiota</keyword>
  <keyword>Satiety</keyword>
  <keyword>Dietary intervention</keyword>
  <!-- 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/NCT03293693
org study id: 2016/648
nct id: NCT03293693
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The overall aim is to investigate the intake of beta-glucan in relation to glucose metabolism
      and satiety in a postprandial study with healthy subjects. The potential effects will be
      related to changes in the gut microbiota, the circulating levels of short chain fatty acids,
      inflammation and gene expression in peripheral mononuclear blood cells
The intervention study will have a fixed order, cross-over design with three test meals
      containing low (0.5 g / 100 g of product), medium (3.5 g / 100 g of product) and high (8 g /
      100 g product) amount of beta -glucans, respectively. The test meals are in the form of
      cereals. All participants will eat the three test meals three constitutive days with 2 weeks
      apart. At day four, the participants will perform a postprandial glucose test (OGTT, 75 g
      glucose in 150 ml water) at Oslo and Akershus University College. Blood samples will be taken
      before and at different time points after glucose test.

      At the screening visit the participants will be asked to limit the intake of dietary fiber
      from grains two weeks prior to the baseline visit (0) and during the study. Otherwise,
      participants will be asked not to change their diet and exercise habits during the study
      period.

      At the baseline visit (visit 0) an OGTT will be performed. OGTT will also be performed at
      visit 1, 3 and 5 after intake of low, medium and high beta-glucan, respectively.

      The participants will receive the test meals at visit 1, 2 and 4.
allocation: Non-Randomized
intervention model: Crossover Assignment
intervention model description: Intervention With cross-over design. Three test meals will be tested.
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Postprandial blood glucose response
time frame: At day 4
description: Blood glucose response after OGTT
measure: Postprandial insulin response
time frame: At day 4
description: insulin response after OGTT
measure: H2 breath response
time frame: At day 4
description: H2 breath response after OGTT
measure: Free fatty acids
time frame: At day 4
description: Plasma free fatty acids are measured after intake of test meals
measure: Microbiota analyses in feces
time frame: At day 4
description: Microbiota analyses in feces are measured before and after intake of test meals. Change in microbiota will be analysed
measure: Serum triglyceride response
time frame: At day 4
description: Triglyceride response are measured are measured after OGTT
measure: Serum cholesterol
time frame: At day 4
description: Serum cholesterol are measured fasting after intake of test meals
measure: hunger and satiety hormones (e.g. GLP1)
time frame: At day 4
description: The response in hunger and satiety hormones after OGTT
measure: Inflammatory markers (e.g. CRP)
time frame: At day 4
description: Response in Inflammatory markers are measured after OGTT
measure: mRNA analyses in PBMC (RT-PCR)
time frame: At day 4
description: PBMC are collected before and after OGTT. The change in mRNA level will be analyzed
measure: Quantitative assessment of metabolites in urine
time frame: At day 4
description: Morning urine are collected before and after intake of test meals. Metabolites in urine will be quantified using UHPLC-qTOF-MS. Change in metabolites before and after test meals will be analyzed
measure: Quantitative assessment of metabolites in plasma
time frame: At day 4
description: Plasma for metabolome analyses are collected after intake of test meals. Metabolites in plasma will be quantified using UHPLC-qTOF-MS.
measure: Visual analogue scale (VAS)
time frame: At day 1
description: Subjective hunger and satiety will be estimated after intake of test meals for one day
measure: Visual analogue scale (VAS)
time frame: At day 3
description: Subjective hunger and satiety will be estimated after intake of test meals for three days
arm group label: Test meal 1
arm group type: Experimental
description: Test meal with 0.5 g beta-glucan
arm group label: Test meal 2
arm group type: Experimental
description: Test meal with 3.5 g beta-glucan
arm group label: Test meal 3
arm group type: Experimental
description: Test meal with 8 g beta-glucan
intervention type: Other
intervention name: 0.5 g beta-glucan
description: Dietary cross-over study with beta-glucan fiber
arm group label: Test meal 1
intervention type: Other
intervention name: 3.5 g beta-glucan
description: Dietary cross-over study with beta-glucan fiber
arm group label: Test meal 2
intervention type: Other
intervention name: 8 g beta-glucan
description: Dietary cross-over study with beta-glucan fiber
arm group label: Test meal 3
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mari CW Myhrstad, PhD
role: Principal Investigator
affiliation: Oslo and Akershus university College
facility: 
country: Norway
responsible party type: Sponsor