<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/NCT03805802</url>
  </required_header>
  <id_info>
    <org_study_id>012019</org_study_id>
    <nct_id>NCT03805802</nct_id>
  </id_info>
  <brief_title>Influence of a Liquid Oat Bran Product on Blood Glucose in Patients With Poorly Controlled Type 2 Diabetes</brief_title>
  <official_title>Influence of a Liquid Oat Bran Product on Blood Glucose in Patients With Poorly Controlled Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stoffwechselzentrum Rhein - Pfalz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Glucanova AB</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Stoffwechselzentrum Rhein - Pfalz</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 effects of an ad libitum addition of a high fiber product to the&#xD;
      regular diet of type 2 diabetes patients on body weight and blood sugar control. In the first&#xD;
      6 weeks half of the participants will receive the high fiber test product and half a&#xD;
      reference product without fiber. After the first 6 weeks both groups will be switched to the&#xD;
      high fiber product.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It has previously been shown that an increase in the consumption of fiber improves glucose&#xD;
      control in type 2 diabetes. In addition, previous pilot studies have shown that a diet solely&#xD;
      based on oat flakes can improve insulin sensitivity and glucose control in poorly controlled&#xD;
      type 2 diabetes. Recent clinical data indicates, that early hyperglycemia can be normalized&#xD;
      by a diet high in fiber. In this controlled pilot study, a food containing liquid oat bran&#xD;
      high in fiber will be studied in type 2 diabetes patients with inadequate glucose control&#xD;
      that are treated with oral medication or with additional once-daily insulin only against a&#xD;
      reference product. 30 patients will be treated with the oat bran product or reference product&#xD;
      over a period of 6 weeks in a double blinded approach, hereafter all participants will be&#xD;
      switched to the oat bran product. The primary endpoint will be fasting glucose after 6 weeks.&#xD;
      Secondary endpoints will be long-term glucose control as measured by HbA1c, self-documented&#xD;
      glucose as well as the body weight and body mass index.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 4, 2019</start_date>
  <completion_date type="Actual">April 1, 2020</completion_date>
  <primary_completion_date type="Actual">April 1, 2020</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>Parallel Assignment</intervention_model>
    <intervention_model_description>First 6 weeks double blinded vs. a reference product and second 6 weeks open label both groups receive the test product in the second 6 weeks.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>The investigator receives reference product and the test product in boxes labelled &quot;stratus&quot; &quot;nimbus&quot; and &quot;cumulus&quot;. first 6 weeks participants are randomly assigned to &quot;stratus&quot; or &quot;nimbus&quot; and the second 6 weeks participants all receive &quot;cumulus&quot;.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Fasting glucose</measure>
    <time_frame>6 weeks</time_frame>
    <description>Change in the concentratino of fasting venous glucose of daily LOB consumption in mg/dl as compared to the change in fasting glucose for the placebo group at 6 weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fasting glucose</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change in the concentratino of fasting venous glucose of daily LOB consumption in mg/dl as compared to the change in fasting glucose for the placebo group at 12 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HBA1c</measure>
    <time_frame>6 weeks</time_frame>
    <description>long-term glucose control as measured by the concentratino of HbA1c concentration in %</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HBA1c</measure>
    <time_frame>12 weeks</time_frame>
    <description>long-term glucose control as measured by the concentratino of HbA1c concentration in %</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-documented glucose</measure>
    <time_frame>6 weeks</time_frame>
    <description>Self-monitored glucose levels extracted from glucometers as a mean of the previous two weeks before study visits in mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-documented glucose</measure>
    <time_frame>12 weeks</time_frame>
    <description>Self-monitored glucose levels extracted from glucometers as a mean of the previous two weeks before study visits in mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>6 weeks</time_frame>
    <description>Chenge in body Weight in kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>12 weeks</time_frame>
    <description>Chenge in body Weight in kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI</measure>
    <time_frame>6 weeks</time_frame>
    <description>Body Mass Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI</measure>
    <time_frame>12 weeks</time_frame>
    <description>Body Mass Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipid metabolism: Serum triglycerides</measure>
    <time_frame>6 weeks</time_frame>
    <description>Markers of lipid metabolism at 6 weeks: triglycerides (mg/dl)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipid metabolism: Serum triglycerides</measure>
    <time_frame>12 weeks</time_frame>
    <description>Markers of lipid metabolism at 12 weeks: triglycerides (mg/dl)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipid metabolism: apolipoprotein A (mg/dl)</measure>
    <time_frame>6 weeks</time_frame>
    <description>Markers of lipid metabolism at 6 weeks: apolipoprotein A (mg/dl)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipid metabolism: apolipoprotein A (mg/dl)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Markers of lipid metabolism at 12 weeks: apolipoprotein A (mg/dl)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipid metabolism: Apolipoprotein B mg/dl</measure>
    <time_frame>6 weeks</time_frame>
    <description>Markers of lipid metabolism at 6 weeks: Apolipoprotein B mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipid metabolism: Apolipoprotein B mg/dl</measure>
    <time_frame>12 weeks</time_frame>
    <description>Markers of lipid metabolism at 12 weeks: Apolipoprotein B mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipid metabolism: Apolipoprotein B / Apolipoprotein A ratio</measure>
    <time_frame>6 weeks</time_frame>
    <description>Metabolism at 6 weeks: Apolipoprotein B mg/dl / Apolipoprotein A mg/dl ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipid metabolism: Apolipoprotein B / Apolipoprotein A ratio</measure>
    <time_frame>12 weeks</time_frame>
    <description>Markers of lipid metabolism at 12 weeks: Apolipoprotein B mg/dl / Apolipoprotein A mg/dl ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipid metabolism: HDL-cholesterol</measure>
    <time_frame>6 weeks</time_frame>
    <description>Markers of lipid metabolism at 6 weeks: HDL-cholesterol mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipid metabolism: HDL-cholesterol</measure>
    <time_frame>12 weeks</time_frame>
    <description>Markers of lipid metabolism at 12 weeks: HDL-cholesterol mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipid metabolism: LDL- cholesterol mg/dl</measure>
    <time_frame>6 weeks</time_frame>
    <description>Markers of lipid metabolism at 6 weeks: LDL- cholesterol mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipid metabolism: LDL- cholesterol mg/dl</measure>
    <time_frame>12 weeks</time_frame>
    <description>Markers of lipid metabolism at 12 weeks: LDL- cholesterol mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microbiome</measure>
    <time_frame>6 weeks</time_frame>
    <description>Microbiome in faeces samples at 6 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microbiome</measure>
    <time_frame>12 weeks</time_frame>
    <description>Microbiome in faeces samples at 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation: Il-6</measure>
    <time_frame>6 weeks</time_frame>
    <description>Markers of inflammation at 6 weeks IL-6 in ng/ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation: hsCRP</measure>
    <time_frame>6 weeks</time_frame>
    <description>Markers of inflammation at 6 weeks hsCRP mg/l</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation: Il-6</measure>
    <time_frame>12 weeks</time_frame>
    <description>Markers of inflammation at 12 weeks IL-6 in ng/ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation: hsCRP</measure>
    <time_frame>12 weeks</time_frame>
    <description>Markers of inflammation at 12 weeks hsCRP mg/l</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Systolic lood pressure</measure>
    <time_frame>6 weeks</time_frame>
    <description>Systolic blood pressure left arm 6 weeks in mm/Hg</description>
  </other_outcome>
  <other_outcome>
    <measure>Diastolic blood pressure</measure>
    <time_frame>6 weeks</time_frame>
    <description>Diastolic blood pressure left arm 6 weeks in mm/Hg</description>
  </other_outcome>
  <other_outcome>
    <measure>Systolic blood pressure</measure>
    <time_frame>12 weeks</time_frame>
    <description>Systolic blood pressure left arm 12 weeks in mm/Hg</description>
  </other_outcome>
  <other_outcome>
    <measure>Diastolic blood pressure</measure>
    <time_frame>12 weeks</time_frame>
    <description>Diastolic blood pressure left arm 12 weeks in mm/Hg</description>
  </other_outcome>
  <other_outcome>
    <measure>Waist circumference</measure>
    <time_frame>6 weeks</time_frame>
    <description>Waist circumference at 6 weeks in cm</description>
  </other_outcome>
  <other_outcome>
    <measure>Waist circumference</measure>
    <time_frame>12 weeks</time_frame>
    <description>Waist circumference at 12 weeks in cm</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>Obesity</condition>
  <condition>Overweight</condition>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>active product</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Once daily ad libitum consumption of one package of the fiber product 6 weeks (blinded phase). Once daily ad libitum consumption of one package of the fiber product 6 weeks (open phase).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>reference product</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Once daily ad libitum consumption of one package of placebo during 6 weeks (blinded phase). Once daily ad libitum consumption of one package of the fiber product 6 weeks (open phase).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>active product</intervention_name>
    <description>Once daily consumption over the period of the study</description>
    <arm_group_label>active product</arm_group_label>
    <arm_group_label>reference product</arm_group_label>
    <other_name>LOB</other_name>
    <other_name>Liquid Oat Bran</other_name>
    <other_name>High fiber product</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>reference product</intervention_name>
    <description>Once daily consumption over the period of the study</description>
    <arm_group_label>reference product</arm_group_label>
    <other_name>placebo food product</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 2 Diabetes with inadequate glucose control and a HbA1c &gt;7,5 and &lt; 9%&#xD;
&#xD;
          -  Treatment with all oral antidiabetic medication or injectable GLP-1 analogues&#xD;
&#xD;
          -  BMI 28,0-39,9 kg/m²&#xD;
&#xD;
          -  Age 30-70 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  insulin treatment&#xD;
&#xD;
          -  Psychiatric Disease&#xD;
&#xD;
          -  Acute Infections&#xD;
&#xD;
          -  Alcohol or drug abuse&#xD;
&#xD;
          -  Acute diverticulitis&#xD;
&#xD;
          -  Malignant tumors or hematologic disorders&#xD;
&#xD;
          -  Heart failure NYHA III-IV&#xD;
&#xD;
          -  Acute coronary syndrome&#xD;
&#xD;
          -  Chronic kidney disease &gt; Stage 3 (KDOQI)&#xD;
&#xD;
          -  Pregnancy or Lactation&#xD;
&#xD;
          -  Previous bariatric interventions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Per M Humpert, M. D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Director of Stoffwechselzentrum Rhein-Pfalz</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stoffwechselzentrum Rhein-Pfalz</name>
      <address>
        <city>Mannheim</city>
        <state>Baden-Württemberg</state>
        <zip>68163</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>January 13, 2019</study_first_submitted>
  <study_first_submitted_qc>January 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>October 20, 2020</last_update_submitted>
  <last_update_submitted_qc>October 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stoffwechselzentrum Rhein - Pfalz</investigator_affiliation>
    <investigator_full_name>Dr. Per Humpert</investigator_full_name>
    <investigator_title>Director of Stoffwechselzentrum Rhein - Pfalz</investigator_title>
  </responsible_party>
  <keyword>fiber</keyword>
  <keyword>type 2 diabetes</keyword>
  <keyword>dietary intervention</keyword>
  <keyword>weight loss</keyword>
  <keyword>glucose control</keyword>
  <keyword>obesity</keyword>
  <keyword>overweight</keyword>
  <keyword>metabolic syndrome</keyword>
  <keyword>oats</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Metabolic Syndrome</mesh_term>
  </condition_browse>
  <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/NCT03805802
org study id: 012019
nct id: NCT03805802
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the effects of an ad libitum addition of a high fiber product to the
      regular diet of type 2 diabetes patients on body weight and blood sugar control. In the first
      6 weeks half of the participants will receive the high fiber test product and half a
      reference product without fiber. After the first 6 weeks both groups will be switched to the
      high fiber product.
It has previously been shown that an increase in the consumption of fiber improves glucose
      control in type 2 diabetes. In addition, previous pilot studies have shown that a diet solely
      based on oat flakes can improve insulin sensitivity and glucose control in poorly controlled
      type 2 diabetes. Recent clinical data indicates, that early hyperglycemia can be normalized
      by a diet high in fiber. In this controlled pilot study, a food containing liquid oat bran
      high in fiber will be studied in type 2 diabetes patients with inadequate glucose control
      that are treated with oral medication or with additional once-daily insulin only against a
      reference product. 30 patients will be treated with the oat bran product or reference product
      over a period of 6 weeks in a double blinded approach, hereafter all participants will be
      switched to the oat bran product. The primary endpoint will be fasting glucose after 6 weeks.
      Secondary endpoints will be long-term glucose control as measured by HbA1c, self-documented
      glucose as well as the body weight and body mass index.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: First 6 weeks double blinded vs. a reference product and second 6 weeks open label both groups receive the test product in the second 6 weeks.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: The investigator receives reference product and the test product in boxes labelled "stratus" "nimbus" and "cumulus". first 6 weeks participants are randomly assigned to "stratus" or "nimbus" and the second 6 weeks participants all receive "cumulus".
measure: Fasting glucose
time frame: 6 weeks
description: Change in the concentratino of fasting venous glucose of daily LOB consumption in mg/dl as compared to the change in fasting glucose for the placebo group at 6 weeks.
measure: Fasting glucose
time frame: 12 weeks
description: Change in the concentratino of fasting venous glucose of daily LOB consumption in mg/dl as compared to the change in fasting glucose for the placebo group at 12 weeks.
measure: HBA1c
time frame: 6 weeks
description: long-term glucose control as measured by the concentratino of HbA1c concentration in %
measure: HBA1c
time frame: 12 weeks
description: long-term glucose control as measured by the concentratino of HbA1c concentration in %
measure: Self-documented glucose
time frame: 6 weeks
description: Self-monitored glucose levels extracted from glucometers as a mean of the previous two weeks before study visits in mg/dl
measure: Self-documented glucose
time frame: 12 weeks
description: Self-monitored glucose levels extracted from glucometers as a mean of the previous two weeks before study visits in mg/dl
measure: Weight
time frame: 6 weeks
description: Chenge in body Weight in kg
measure: Weight
time frame: 12 weeks
description: Chenge in body Weight in kg
measure: BMI
time frame: 6 weeks
description: Body Mass Index
measure: BMI
time frame: 12 weeks
description: Body Mass Index
measure: Lipid metabolism: Serum triglycerides
time frame: 6 weeks
description: Markers of lipid metabolism at 6 weeks: triglycerides (mg/dl)
measure: Lipid metabolism: Serum triglycerides
time frame: 12 weeks
description: Markers of lipid metabolism at 12 weeks: triglycerides (mg/dl)
measure: Lipid metabolism: apolipoprotein A (mg/dl)
time frame: 6 weeks
description: Markers of lipid metabolism at 6 weeks: apolipoprotein A (mg/dl)
measure: Lipid metabolism: apolipoprotein A (mg/dl)
time frame: 12 weeks
description: Markers of lipid metabolism at 12 weeks: apolipoprotein A (mg/dl)
measure: Lipid metabolism: Apolipoprotein B mg/dl
time frame: 6 weeks
description: Markers of lipid metabolism at 6 weeks: Apolipoprotein B mg/dl
measure: Lipid metabolism: Apolipoprotein B mg/dl
time frame: 12 weeks
description: Markers of lipid metabolism at 12 weeks: Apolipoprotein B mg/dl
measure: Lipid metabolism: Apolipoprotein B / Apolipoprotein A ratio
time frame: 6 weeks
description: Metabolism at 6 weeks: Apolipoprotein B mg/dl / Apolipoprotein A mg/dl ratio
measure: Lipid metabolism: Apolipoprotein B / Apolipoprotein A ratio
time frame: 12 weeks
description: Markers of lipid metabolism at 12 weeks: Apolipoprotein B mg/dl / Apolipoprotein A mg/dl ratio
measure: Lipid metabolism: HDL-cholesterol
time frame: 6 weeks
description: Markers of lipid metabolism at 6 weeks: HDL-cholesterol mg/dl
measure: Lipid metabolism: HDL-cholesterol
time frame: 12 weeks
description: Markers of lipid metabolism at 12 weeks: HDL-cholesterol mg/dl
measure: Lipid metabolism: LDL- cholesterol mg/dl
time frame: 6 weeks
description: Markers of lipid metabolism at 6 weeks: LDL- cholesterol mg/dl
measure: Lipid metabolism: LDL- cholesterol mg/dl
time frame: 12 weeks
description: Markers of lipid metabolism at 12 weeks: LDL- cholesterol mg/dl
measure: Microbiome
time frame: 6 weeks
description: Microbiome in faeces samples at 6 weeks
measure: Microbiome
time frame: 12 weeks
description: Microbiome in faeces samples at 12 weeks
measure: Inflammation: Il-6
time frame: 6 weeks
description: Markers of inflammation at 6 weeks IL-6 in ng/ml
measure: Inflammation: hsCRP
time frame: 6 weeks
description: Markers of inflammation at 6 weeks hsCRP mg/l
measure: Inflammation: Il-6
time frame: 12 weeks
description: Markers of inflammation at 12 weeks IL-6 in ng/ml
measure: Inflammation: hsCRP
time frame: 12 weeks
description: Markers of inflammation at 12 weeks hsCRP mg/l
measure: Systolic lood pressure
time frame: 6 weeks
description: Systolic blood pressure left arm 6 weeks in mm/Hg
measure: Diastolic blood pressure
time frame: 6 weeks
description: Diastolic blood pressure left arm 6 weeks in mm/Hg
measure: Systolic blood pressure
time frame: 12 weeks
description: Systolic blood pressure left arm 12 weeks in mm/Hg
measure: Diastolic blood pressure
time frame: 12 weeks
description: Diastolic blood pressure left arm 12 weeks in mm/Hg
measure: Waist circumference
time frame: 6 weeks
description: Waist circumference at 6 weeks in cm
measure: Waist circumference
time frame: 12 weeks
description: Waist circumference at 12 weeks in cm
arm group label: active product
arm group type: Experimental
description: Once daily ad libitum consumption of one package of the fiber product 6 weeks (blinded phase). Once daily ad libitum consumption of one package of the fiber product 6 weeks (open phase).
arm group label: reference product
arm group type: Placebo Comparator
description: Once daily ad libitum consumption of one package of placebo during 6 weeks (blinded phase). Once daily ad libitum consumption of one package of the fiber product 6 weeks (open phase).
intervention type: Other
intervention name: active product
description: Once daily consumption over the period of the study
arm group label: active product
arm group label: reference product
other name: LOB
other name: Liquid Oat Bran
other name: High fiber product
intervention type: Other
intervention name: reference product
description: Once daily consumption over the period of the study
arm group label: reference product
other name: placebo food product
criteria: 
gender: All
minimum age: 30 Years
maximum age: 70 Years
healthy volunteers: No
last name: Per M Humpert, M. D.
role: Principal Investigator
affiliation: Director of Stoffwechselzentrum Rhein-Pfalz
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Stoffwechselzentrum Rhein - Pfalz
investigator full name: Dr. Per Humpert
investigator title: Director of Stoffwechselzentrum Rhein - Pfalz
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Overweight
mesh term: Metabolic Syndrome
sharing ipd: No