<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/NCT03830736</url>
  </required_header>
  <id_info>
    <org_study_id>Protokoll 2018/8</org_study_id>
    <nct_id>NCT03830736</nct_id>
  </id_info>
  <brief_title>Health Effects of Oats and Oat Bioactive in Human</brief_title>
  <official_title>Effects of Oat and Oat Components on Cardiometabolic- and Cognitive Test Variables</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lund University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Swedish Foundation for Strategic Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Lund University</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>
      Aim of the study is to investigate health effects of oats and oat derived components, in&#xD;
      human intervention studies, with the purpose to build new knowledge for development of&#xD;
      cardiometabolic protective foods.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall goal is to increase the knowledge which can be used for the development of food&#xD;
      products with anti-diabetic properties, with the purpose to facilitate healthier food choices&#xD;
      for people. More specifically the primary purpose of this project is to evaluate effects in&#xD;
      healthy humans on cardiometabolic test markers of oat and oat based product. The new&#xD;
      knowledge will form a base for the development of oat based food products with added health&#xD;
      values.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 18, 2019</start_date>
  <completion_date type="Actual">December 30, 2019</completion_date>
  <primary_completion_date type="Actual">May 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>a randomized blinded cross-over study</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood glucose regulation</measure>
    <time_frame>0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)</time_frame>
    <description>Postprandial blood glucose regulation (incremental area under the curve) acute after intake of the test products and at forthcoming meals within 5.5 hours after consumption of test products.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum insulin</measure>
    <time_frame>0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)</time_frame>
    <description>Acute effects of postprandial serum insulin concentrations (incremental area under the curve) after intake of the test products.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plasma GLP-1 (glucagon-like peptide-1 )</measure>
    <time_frame>0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)</time_frame>
    <description>Gastro-intestinale hormones involved in appetite and metabolic regulation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IL (interleukin)-6</measure>
    <time_frame>0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)</time_frame>
    <description>Inflammatory markers in blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma PYY (peptide tyrosine tyrosine)</measure>
    <time_frame>0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)</time_frame>
    <description>Gastro-intestinale hormones involved in appetite and metabolic regulation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IL- 1beta</measure>
    <time_frame>0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)</time_frame>
    <description>Inflammatory markers in blood</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Subjective appetite sensations</measure>
    <time_frame>0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)</time_frame>
    <description>Determined with VAS (visual analogue scale) scales (0-100 mm) as a range of subjective sensations related to appetite (such as hunger, desire to eat or fullness)</description>
  </other_outcome>
  <other_outcome>
    <measure>Breath hydrogen concentrations</measure>
    <time_frame>0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)</time_frame>
    <description>Indicator of gut fermentation</description>
  </other_outcome>
  <other_outcome>
    <measure>Mood (valence and activity)</measure>
    <time_frame>0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)</time_frame>
    <description>Determined with VAS (visual analogue scale) scales 0-100 mm</description>
  </other_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Postprandial Glucose Regulation</condition>
  <arm_group>
    <arm_group_label>Control product</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A glucose solution (glucose and water) based on 42 gram carbohydrates.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oat Beverage 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The test product is an oat based beverage with added vegetable oil. The test portion is based on 42 gram available carbohydrates and consumed as a breakfast meal prior to determinations of test variables in the morning.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oat Beverage 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The test product is an oat based beverage with added vegetable oil. The test portion is based on 42 gram available carbohydrates and consumed as a breakfast meal prior to determinations of test variables in the morning.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oat Beverage 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The test product is an oat based beverage with added vegetable oil. The test portion is based on 42 gram available carbohydrates and consumed as a breakfast meal prior to determinations of test variables in the morning.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oat Beverage 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The test product is an oat based beverage. The test portion is based on 42 gram available carbohydrates and consumed as a breakfast meal prior to determinations of test variables in the morning.</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Oat Beverage 1</intervention_name>
    <description>Oat based beverage with added different concentration of extracted oat component.</description>
    <arm_group_label>Oat Beverage 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Oat Beverage 2</intervention_name>
    <description>Oat based beverage with added different concentration of extracted oat component.</description>
    <arm_group_label>Oat Beverage 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Oat Beverage 3</intervention_name>
    <description>Oat based beverage with added different concentration of extracted oat component.</description>
    <arm_group_label>Oat Beverage 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Oat Beverage 4</intervention_name>
    <description>Oat based beverage with added different concentration of extracted oat component.</description>
    <arm_group_label>Oat Beverage 4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Control product</intervention_name>
    <description>Glucose based beverage without added test components is used as control product</description>
    <arm_group_label>Control product</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy adults&#xD;
&#xD;
          -  BMI 18,5 - 25&#xD;
&#xD;
          -  non smokers&#xD;
&#xD;
          -  consuming a non-vegetarian diet that follows the Nordic guidances&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Fasting blood glucose concentration &gt;6.1 mmol/l&#xD;
&#xD;
          -  known cardio-metabolic disease (e.g. diabetes, hypertension, metabolic syndrome),&#xD;
             gastro-intestinal disorders such as IBS (irritable bowel syndrome) that can interfere&#xD;
             with the study results, food allergies. Further no antibiotics or probiotics should&#xD;
             have been consumed within 4 weeks prior to and during the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anne Nilsson</last_name>
    <role>Study Chair</role>
    <affiliation>Lund University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Food Technology, engineering and Nutrition, LTH, Lund University</name>
      <address>
        <city>Lund</city>
        <zip>22100</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>April 30, 2020</last_update_submitted>
  <last_update_submitted_qc>April 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lund University</investigator_affiliation>
    <investigator_full_name>Anne Nilsson</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03830736
org study id: Protokoll 2018/8
nct id: NCT03830736
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Aim of the study is to investigate health effects of oats and oat derived components, in
      human intervention studies, with the purpose to build new knowledge for development of
      cardiometabolic protective foods.
The overall goal is to increase the knowledge which can be used for the development of food
      products with anti-diabetic properties, with the purpose to facilitate healthier food choices
      for people. More specifically the primary purpose of this project is to evaluate effects in
      healthy humans on cardiometabolic test markers of oat and oat based product. The new
      knowledge will form a base for the development of oat based food products with added health
      values.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: a randomized blinded cross-over study
primary purpose: Prevention
masking: Single (Participant)
measure: Blood glucose regulation
time frame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
description: Postprandial blood glucose regulation (incremental area under the curve) acute after intake of the test products and at forthcoming meals within 5.5 hours after consumption of test products.
measure: Serum insulin
time frame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
description: Acute effects of postprandial serum insulin concentrations (incremental area under the curve) after intake of the test products.
measure: plasma GLP-1 (glucagon-like peptide-1 )
time frame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
description: Gastro-intestinale hormones involved in appetite and metabolic regulation
measure: IL (interleukin)-6
time frame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
description: Inflammatory markers in blood
measure: Plasma PYY (peptide tyrosine tyrosine)
time frame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
description: Gastro-intestinale hormones involved in appetite and metabolic regulation
measure: IL- 1beta
time frame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
description: Inflammatory markers in blood
measure: Subjective appetite sensations
time frame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
description: Determined with VAS (visual analogue scale) scales (0-100 mm) as a range of subjective sensations related to appetite (such as hunger, desire to eat or fullness)
measure: Breath hydrogen concentrations
time frame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
description: Indicator of gut fermentation
measure: Mood (valence and activity)
time frame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
description: Determined with VAS (visual analogue scale) scales 0-100 mm
arm group label: Control product
arm group type: Placebo Comparator
description: A glucose solution (glucose and water) based on 42 gram carbohydrates.
arm group label: Oat Beverage 1
arm group type: Experimental
description: The test product is an oat based beverage with added vegetable oil. The test portion is based on 42 gram available carbohydrates and consumed as a breakfast meal prior to determinations of test variables in the morning.
arm group label: Oat Beverage 2
arm group type: Experimental
description: The test product is an oat based beverage with added vegetable oil. The test portion is based on 42 gram available carbohydrates and consumed as a breakfast meal prior to determinations of test variables in the morning.
arm group label: Oat Beverage 3
arm group type: Experimental
description: The test product is an oat based beverage with added vegetable oil. The test portion is based on 42 gram available carbohydrates and consumed as a breakfast meal prior to determinations of test variables in the morning.
arm group label: Oat Beverage 4
arm group type: Experimental
description: The test product is an oat based beverage. The test portion is based on 42 gram available carbohydrates and consumed as a breakfast meal prior to determinations of test variables in the morning.
intervention type: Combination Product
intervention name: Oat Beverage 1
description: Oat based beverage with added different concentration of extracted oat component.
arm group label: Oat Beverage 1
intervention type: Combination Product
intervention name: Oat Beverage 2
description: Oat based beverage with added different concentration of extracted oat component.
arm group label: Oat Beverage 2
intervention type: Combination Product
intervention name: Oat Beverage 3
description: Oat based beverage with added different concentration of extracted oat component.
arm group label: Oat Beverage 3
intervention type: Combination Product
intervention name: Oat Beverage 4
description: Oat based beverage with added different concentration of extracted oat component.
arm group label: Oat Beverage 4
intervention type: Combination Product
intervention name: Control product
description: Glucose based beverage without added test components is used as control product
arm group label: Control product
criteria: 
gender: All
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anne Nilsson
role: Study Chair
affiliation: Lund University
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Lund University
investigator full name: Anne Nilsson
investigator title: Associate professor
sharing ipd: No