<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/NCT01681173</url>
  </required_header>
  <id_info>
    <org_study_id>DDS-FKZ 232/11/08</org_study_id>
    <nct_id>NCT01681173</nct_id>
  </id_info>
  <brief_title>OPTIFIT-Optimal Fiber Trial for Diabetes Prevention</brief_title>
  <official_title>Investigation of the Effect of Insoluble Dietary Fiber on Carbohydrate and Lipid Metabolism and the Prevention of Diabetes Mellitus Type 2 in Subjects With Impaired Glucose Tolerance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>German Institute of Human Nutrition</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>German Diabetes Foundation, Munich, Germany</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ernst von Bergmann Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital Tuebingen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>German Institute of Human Nutrition</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      High intake of insoluble fiber is strongly associated with a reduced incidence of diabetes&#xD;
      and cardiovascular events in prospective observation studies. Our primary objective is to&#xD;
      compare a life style diabetes prevention program(PRAEDIAS) with and without added insoluble&#xD;
      fibers in its effectiveness to prevent incident diabetes type 2 in high risk individuals with&#xD;
      impaired glucose tolerance. Subjects with IGT not willing to participate in the intervention&#xD;
      will be used as independent controls. Secondary aims are to identify mechanisms of action&#xD;
      with regard to body composition, anti-inflammatory and metabolic effects of fibers. We&#xD;
      propose a randomized, prospective intervention study. The results will be of general&#xD;
      relevance for guidance of fiber intake in the population and will help the food industry to&#xD;
      design healthy high fiber foods. Fiber can be added at low cost to numerous foods. Increased&#xD;
      fiber intake may therefore provide a simple non-cognitive prevention strategy effective at&#xD;
      the population level.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall objective is to investigate whether insoluble fibers added to standard nutrition&#xD;
      can reduce the progression of impairment of glucose metabolism in a high risk population with&#xD;
      impaired glucose metabolism. Large prospective cohort studies clearly show that mainly&#xD;
      insoluble cereal fiber from whole grains is associated with reduced risk of type 2 diabetes&#xD;
      and cardiovascular disease. However, there is a lack of evidence from prospective&#xD;
      intervention studies targeted to evaluate the potential of dietary fibers to reduce diabetes&#xD;
      and cardiovascular disease as recently stated by the Cochrane Foundation. Dietary fiber&#xD;
      intake is generally much lower than currently recommended, which may in part be related to&#xD;
      side effects of whole grain nutrients and their gustatory properties. Intestinally&#xD;
      uncomfortable effects are at least partly related to fermentation which is much less induced&#xD;
      by insoluble non-fermentable fibers than by soluble fermentable fibers. The prospective&#xD;
      demonstration of beneficial effects of insoluble fibers in preventing diabetes type 2 will&#xD;
      allow detailed nutritional recommendations. This may serve to support the consumption of&#xD;
      metabolically beneficial constituents of fiber-rich diets and help to increase fiber intake&#xD;
      by high fiber natural nutrients or everyday nutrients enriched in insoluble natural fibers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2010</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of 2h-postprandial blood glucose from IGT to diabetes mellitus type 2 or normal glucose tolerance (NGT)</measure>
    <time_frame>0, 12, 24 months</time_frame>
    <description>Change of the glucose metabolism (OGTT)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of insulin sensitivity</measure>
    <time_frame>0, 12, 24 months</time_frame>
    <description>Measurement by HOMA and OGIS from the OGTT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of insulin secretion</measure>
    <time_frame>0, 12, 24 months</time_frame>
    <description>Measurement by the OGTT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expression of inflammatory markers in blood</measure>
    <time_frame>0, 6, 12, 18, 24 months</time_frame>
    <description>CRP, leukocytes, adipocytokines</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biometric data</measure>
    <time_frame>0, 6, 12, 18, 24 months</time_frame>
    <description>Nutritional impact of blood pressure, anthropometry (body weight and body composition)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of cognitive performance</measure>
    <time_frame>0, 12, 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Development of indices for the prediction of fat mass</measure>
    <time_frame>0, 12, 24 months</time_frame>
    <description>Change of fat fraction in liver, abdominal and in the total body fat measuring by MRI/H1-spectroscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determination of gene expression in adipose tissue</measure>
    <time_frame>0, 12, 24 month</time_frame>
    <description>Determination of inflammatory and other transcripts in sc adipose tissue in a fat biopsy.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Diabetes</condition>
  <condition>Nutrition Disorders</condition>
  <condition>Obesity</condition>
  <condition>Overweight</condition>
  <condition>Metabolic Syndrome x</condition>
  <condition>Body Weight</condition>
  <condition>Glucose Metabolism Disorders</condition>
  <condition>Metabolic Diseases</condition>
  <arm_group>
    <arm_group_label>Drink enriched in fibers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>7,5g enriched fiber drinks, BID</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo drink</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Placebo drink, BID</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Fiber</intervention_name>
    <description>200ml drinks enriched with 7,5g of fiber (90% insoluble fiber, 10% soluble fiber), BID, over 24 months</description>
    <arm_group_label>Drink enriched in fibers</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>200ml Placebo, BID, over 24 months</description>
    <arm_group_label>Placebo drink</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Impaired glucose tolerance&#xD;
&#xD;
          -  Age&gt;18years old&#xD;
&#xD;
          -  both gender&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetes type 1 and type 2&#xD;
&#xD;
          -  chronic or malignant disease&#xD;
&#xD;
          -  Intake of metabolic influence drugs&#xD;
&#xD;
          -  Food allergies, fiber intolerance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andreas FH Pfeiffer, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>German Institute of Human Nutrition Potsdam-Rehbruecke</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>German Instiute of Human Nutrition</name>
      <address>
        <city>Potsdam-Rehbruecke</city>
        <state>Nuthetal</state>
        <zip>14558</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charite University</name>
      <address>
        <city>Berlin</city>
        <zip>12200</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>February 4, 2015</last_update_submitted>
  <last_update_submitted_qc>February 4, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 5, 2015</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>Chief, Department of Clinical Nutrition</investigator_title>
  </responsible_party>
  <keyword>Nutritional support</keyword>
  <keyword>Diet therapy</keyword>
  <keyword>Diabetes prevention</keyword>
  <keyword>Insoluble fiber</keyword>
  <keyword>Healthy life style</keyword>
  <keyword>Weight loss</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Metabolic Diseases</mesh_term>
    <mesh_term>Glucose Metabolism Disorders</mesh_term>
    <mesh_term>Nutrition Disorders</mesh_term>
    <mesh_term>Body Weight</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/NCT01681173
org study id: DDS-FKZ 232/11/08
nct id: NCT01681173
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
High intake of insoluble fiber is strongly associated with a reduced incidence of diabetes
      and cardiovascular events in prospective observation studies. Our primary objective is to
      compare a life style diabetes prevention program(PRAEDIAS) with and without added insoluble
      fibers in its effectiveness to prevent incident diabetes type 2 in high risk individuals with
      impaired glucose tolerance. Subjects with IGT not willing to participate in the intervention
      will be used as independent controls. Secondary aims are to identify mechanisms of action
      with regard to body composition, anti-inflammatory and metabolic effects of fibers. We
      propose a randomized, prospective intervention study. The results will be of general
      relevance for guidance of fiber intake in the population and will help the food industry to
      design healthy high fiber foods. Fiber can be added at low cost to numerous foods. Increased
      fiber intake may therefore provide a simple non-cognitive prevention strategy effective at
      the population level.
The overall objective is to investigate whether insoluble fibers added to standard nutrition
      can reduce the progression of impairment of glucose metabolism in a high risk population with
      impaired glucose metabolism. Large prospective cohort studies clearly show that mainly
      insoluble cereal fiber from whole grains is associated with reduced risk of type 2 diabetes
      and cardiovascular disease. However, there is a lack of evidence from prospective
      intervention studies targeted to evaluate the potential of dietary fibers to reduce diabetes
      and cardiovascular disease as recently stated by the Cochrane Foundation. Dietary fiber
      intake is generally much lower than currently recommended, which may in part be related to
      side effects of whole grain nutrients and their gustatory properties. Intestinally
      uncomfortable effects are at least partly related to fermentation which is much less induced
      by insoluble non-fermentable fibers than by soluble fermentable fibers. The prospective
      demonstration of beneficial effects of insoluble fibers in preventing diabetes type 2 will
      allow detailed nutritional recommendations. This may serve to support the consumption of
      metabolically beneficial constituents of fiber-rich diets and help to increase fiber intake
      by high fiber natural nutrients or everyday nutrients enriched in insoluble natural fibers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Change of 2h-postprandial blood glucose from IGT to diabetes mellitus type 2 or normal glucose tolerance (NGT)
time frame: 0, 12, 24 months
description: Change of the glucose metabolism (OGTT)
measure: Change of insulin sensitivity
time frame: 0, 12, 24 months
description: Measurement by HOMA and OGIS from the OGTT
measure: Change of insulin secretion
time frame: 0, 12, 24 months
description: Measurement by the OGTT
measure: Expression of inflammatory markers in blood
time frame: 0, 6, 12, 18, 24 months
description: CRP, leukocytes, adipocytokines
measure: Biometric data
time frame: 0, 6, 12, 18, 24 months
description: Nutritional impact of blood pressure, anthropometry (body weight and body composition)
measure: Assessment of cognitive performance
time frame: 0, 12, 24 months
measure: Development of indices for the prediction of fat mass
time frame: 0, 12, 24 months
description: Change of fat fraction in liver, abdominal and in the total body fat measuring by MRI/H1-spectroscopy
measure: Determination of gene expression in adipose tissue
time frame: 0, 12, 24 month
description: Determination of inflammatory and other transcripts in sc adipose tissue in a fat biopsy.
arm group label: Drink enriched in fibers
arm group type: Experimental
description: 7,5g enriched fiber drinks, BID
arm group label: Placebo drink
arm group type: Experimental
description: Placebo drink, BID
intervention type: Dietary Supplement
intervention name: Fiber
description: 200ml drinks enriched with 7,5g of fiber (90% insoluble fiber, 10% soluble fiber), BID, over 24 months
arm group label: Drink enriched in fibers
intervention type: Dietary Supplement
intervention name: Placebo
description: 200ml Placebo, BID, over 24 months
arm group label: Placebo drink
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andreas FH Pfeiffer, Prof.
role: Principal Investigator
affiliation: German Institute of Human Nutrition Potsdam-Rehbruecke
facility: 
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: Chief, Department of Clinical Nutrition
mesh term: Diabetes Mellitus
mesh term: Overweight
mesh term: Metabolic Syndrome
mesh term: Metabolic Diseases
mesh term: Glucose Metabolism Disorders
mesh term: Nutrition Disorders
mesh term: Body Weight