<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/NCT01698112</url>
  </required_header>
  <id_info>
    <org_study_id>PreDiabetes Flax</org_study_id>
    <secondary_id>7-06-RA-61</secondary_id>
    <nct_id>NCT01698112</nct_id>
  </id_info>
  <brief_title>Does Flaxseed Supplementation Improve Glycemic Control in Individuals With Pre-diabetes?</brief_title>
  <official_title>Does Flaxseed Supplementation Improve Glycemic Control in Individuals With Pre-diabetes?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Colorado Springs</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Colorado Springs</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project is a clinical intervention trial that will determine the role of a functional&#xD;
      food, flaxseed, on the control of blood glucose levels in people with pre-diabetes. People&#xD;
      with pre-diabetes have high blood glucose levels since their cells do not respond to insulin&#xD;
      as they should. Over time, people with pre-diabetes may progress to type 2 diabetes and have&#xD;
      increased risk for heart and kidney diseases. Although the long-term complications associated&#xD;
      with type 2 diabetes are well-recognized, clinicians and researchers are now realizing that&#xD;
      some long-term damage to the body, especially the heart and circulatory system, may already&#xD;
      be occurring during pre-diabetes. Consequently, clinicians are recognizing that glucose&#xD;
      control, through diet, exercise and, if necessary, medications, is as important for people&#xD;
      with pre-diabetes as it is for people with type 2 diabetes.&#xD;
&#xD;
      Standard treatments for pre-diabetes are glucose control through diet, exercise, and drugs. A&#xD;
      possible treatment that could be added to the standard treatments is intake of flaxseed. Few&#xD;
      studies have looked at the effect of flaxseed intake on glucose control and those that have&#xD;
      enrolled people with type 2 diabetes. To date, no studies have reported flaxseed's affect on&#xD;
      controlling blood glucose in people with pre-diabetes. Therefore, more research is needed to&#xD;
      determine if flaxseed is an effective means of controlling glucose levels in people with&#xD;
      pre-diabetes.&#xD;
&#xD;
      This study will help determine whether or not eating modest amounts of flaxseed every day&#xD;
      will improve blood glucose and insulin levels in overweight or obese men and postmenopausal&#xD;
      women with pre-diabetes. It will also show if flaxseed intake will reduce the degree of&#xD;
      inflammation they are experiencing.&#xD;
&#xD;
      If flaxseed consumption does help control blood glucose levels in people with pre-diabetes&#xD;
      and reduce the degree of inflammation they are experiencing, it may help prevent or delay&#xD;
      their progression to type 2 diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pre-diabetes is characterized by hyperglycemia due to ineffective insulin or 'insulin&#xD;
      resistance'. Over time, people with pre-diabetes may progress to type 2 diabetes and&#xD;
      experience complications including cardiovascular and peripheral vascular disease,&#xD;
      hyperlipidemia, retinopathy, neuropathy, and/or nephropathy. Conventional interventions for&#xD;
      pre-diabetes are glucose control through diet, exercise, and, if necessary, medications. An&#xD;
      efficient but still uncommon adjunct intervention is flaxseed supplementation. Since few&#xD;
      studies have examined the affect of flaxseed supplementation on type 2 diabetes and to date,&#xD;
      no studies have reported flaxseed's influence on glycemic control in individuals with&#xD;
      pre-diabetes, additional research is warranted. The objective of this study is to determine&#xD;
      the affect of consuming flaxseed on fasting plasma glucose, insulin, fructosamine,&#xD;
      adiponectin, fatty acid concentrations, serum interleukin-6 (hs-IL-6), C-reactive protein&#xD;
      (hs-CRP), and urinary lignan excretion in overweight or obese men and postmenopausal women&#xD;
      with pre-diabetes. This research will provide data for the strength of the relationship&#xD;
      between regular flaxseed intake and biomarkers for pre-diabetes and glycemic control as well&#xD;
      as adiponectin values and markers of inflammation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2006</start_date>
  <completion_date type="Actual">June 2009</completion_date>
  <primary_completion_date type="Actual">June 2009</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fasting glucose</measure>
    <time_frame>beginning and end of each 12-week intervention (start of 1st week and end of 12th week)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Fasting insulin</measure>
    <time_frame>beginning and end of each 12-week intervention (start of 1st week and end of 12th week)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Fasting fructosamine</measure>
    <time_frame>beginning and end of each 12-week intervention (start of 1st week and end of 12th week)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>C-reactive protein</measure>
    <time_frame>beginning and end of each 12-week intervention (start of 1st week and end of 12th week)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>interleukin 6</measure>
    <time_frame>beginning and end of each 12-week intervention (start of 1st week and end of 12th week)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adiponectin</measure>
    <time_frame>beginning and end of each 12-week intervention (start of 1st week and end of 12th week)</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>PreDiabetes</condition>
  <arm_group>
    <arm_group_label>Flaxseed High Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Flaxseed Low Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Flaxseed control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Flaxseed High Dose</intervention_name>
    <description>26 gram flaxseed intervention</description>
    <arm_group_label>Flaxseed High Dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Flaxseed Low Dose</intervention_name>
    <description>13 grams flaxseed</description>
    <arm_group_label>Flaxseed Low Dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  (1) no unresolved health conditions (e.g. if high blood pressure is present it is&#xD;
             under control due to diet and/or medications) and no diagnosis of type 2 diabetes;&#xD;
&#xD;
          -  (2) non-smoking status;&#xD;
&#xD;
          -  (3) no regular history of flaxseed or flaxseed oil supplement or fish oil supplement&#xD;
             intake;&#xD;
&#xD;
          -  (4) no regular history of sunflower seed intake (1/8 cup &lt; 1 time per week); fish&#xD;
             intake (&lt; 12 ounces of fish/week); and soy intake (1 serving of soy &lt; 3 times per&#xD;
             week; 1 serving of soy equals 3 oz. tofu, 8 oz. soy milk, ¼ c. soy nuts or ½ c.&#xD;
             edamame);&#xD;
&#xD;
          -  (5) willingness to follow study protocol, scheduling, and testing location;&#xD;
&#xD;
          -  (6) body mass index (BMI) of 25-34.9 kg/m2;&#xD;
&#xD;
          -  (7) men or postmenopausal women (no menstrual cycle for &gt; 6 months; women who have had&#xD;
             a hysterectomy are eligible for participation) ages 50-65 years;&#xD;
&#xD;
          -  (8) fasting glucose value of &gt; 100 and &lt; 126 mg/dL.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (1) unresolved health conditions or diagnosis of type 2 diabetes;&#xD;
&#xD;
          -  (2) smokes;&#xD;
&#xD;
          -  (3) regular history of flaxseed or flaxseed oil supplement or fish oil supplement&#xD;
             intake;&#xD;
&#xD;
          -  (4) regular history of sunflower seed intake (1/8 cup &lt; 1 time per week); fish intake&#xD;
             (&lt; 12 ounces of fish/week); and soy intake (1 serving of soy &lt; 3 times per week; 1&#xD;
             serving of soy equals 3 oz. tofu, 8 oz. soy milk, ¼ c. soy nuts or ½ c. edamame);&#xD;
&#xD;
          -  (5) unwillingness to follow study protocol, scheduling, and testing location;&#xD;
&#xD;
          -  (6) body mass index (BMI) less than 25 or greater than 34.9 kg/m2;&#xD;
&#xD;
          -  (7) premenopausal women;&#xD;
&#xD;
          -  (8) men or postmenopausal women less than 50 or greater than 65 years of age;&#xD;
&#xD;
          -  (9) fasting glucose value of less than 100 or greater than 126 mg/dL.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrea Hutchins, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Colorado Springs</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Colorado Springs</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80918</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Montana</name>
      <address>
        <city>Missoula</city>
        <state>Montana</state>
        <zip>59812</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>September 27, 2012</last_update_submitted>
  <last_update_submitted_qc>September 27, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 2, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Colorado, Colorado Springs</investigator_affiliation>
    <investigator_full_name>Andrea Hutchins</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prediabetic State</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/NCT01698112
org study id: PreDiabetes Flax
secondary id: 7-06-RA-61
nct id: NCT01698112
lead sponsor: 
has dmc: No
This project is a clinical intervention trial that will determine the role of a functional
      food, flaxseed, on the control of blood glucose levels in people with pre-diabetes. People
      with pre-diabetes have high blood glucose levels since their cells do not respond to insulin
      as they should. Over time, people with pre-diabetes may progress to type 2 diabetes and have
      increased risk for heart and kidney diseases. Although the long-term complications associated
      with type 2 diabetes are well-recognized, clinicians and researchers are now realizing that
      some long-term damage to the body, especially the heart and circulatory system, may already
      be occurring during pre-diabetes. Consequently, clinicians are recognizing that glucose
      control, through diet, exercise and, if necessary, medications, is as important for people
      with pre-diabetes as it is for people with type 2 diabetes.

      Standard treatments for pre-diabetes are glucose control through diet, exercise, and drugs. A
      possible treatment that could be added to the standard treatments is intake of flaxseed. Few
      studies have looked at the effect of flaxseed intake on glucose control and those that have
      enrolled people with type 2 diabetes. To date, no studies have reported flaxseed's affect on
      controlling blood glucose in people with pre-diabetes. Therefore, more research is needed to
      determine if flaxseed is an effective means of controlling glucose levels in people with
      pre-diabetes.

      This study will help determine whether or not eating modest amounts of flaxseed every day
      will improve blood glucose and insulin levels in overweight or obese men and postmenopausal
      women with pre-diabetes. It will also show if flaxseed intake will reduce the degree of
      inflammation they are experiencing.

      If flaxseed consumption does help control blood glucose levels in people with pre-diabetes
      and reduce the degree of inflammation they are experiencing, it may help prevent or delay
      their progression to type 2 diabetes.
Pre-diabetes is characterized by hyperglycemia due to ineffective insulin or 'insulin
      resistance'. Over time, people with pre-diabetes may progress to type 2 diabetes and
      experience complications including cardiovascular and peripheral vascular disease,
      hyperlipidemia, retinopathy, neuropathy, and/or nephropathy. Conventional interventions for
      pre-diabetes are glucose control through diet, exercise, and, if necessary, medications. An
      efficient but still uncommon adjunct intervention is flaxseed supplementation. Since few
      studies have examined the affect of flaxseed supplementation on type 2 diabetes and to date,
      no studies have reported flaxseed's influence on glycemic control in individuals with
      pre-diabetes, additional research is warranted. The objective of this study is to determine
      the affect of consuming flaxseed on fasting plasma glucose, insulin, fructosamine,
      adiponectin, fatty acid concentrations, serum interleukin-6 (hs-IL-6), C-reactive protein
      (hs-CRP), and urinary lignan excretion in overweight or obese men and postmenopausal women
      with pre-diabetes. This research will provide data for the strength of the relationship
      between regular flaxseed intake and biomarkers for pre-diabetes and glycemic control as well
      as adiponectin values and markers of inflammation.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Fasting glucose
time frame: beginning and end of each 12-week intervention (start of 1st week and end of 12th week)
measure: Fasting insulin
time frame: beginning and end of each 12-week intervention (start of 1st week and end of 12th week)
measure: Fasting fructosamine
time frame: beginning and end of each 12-week intervention (start of 1st week and end of 12th week)
measure: C-reactive protein
time frame: beginning and end of each 12-week intervention (start of 1st week and end of 12th week)
measure: interleukin 6
time frame: beginning and end of each 12-week intervention (start of 1st week and end of 12th week)
measure: adiponectin
time frame: beginning and end of each 12-week intervention (start of 1st week and end of 12th week)
arm group label: Flaxseed High Dose
arm group type: Experimental
arm group label: Flaxseed Low Dose
arm group type: Experimental
arm group label: Flaxseed control
arm group type: No Intervention
intervention type: Dietary Supplement
intervention name: Flaxseed High Dose
description: 26 gram flaxseed intervention
arm group label: Flaxseed High Dose
intervention type: Dietary Supplement
intervention name: Flaxseed Low Dose
description: 13 grams flaxseed
arm group label: Flaxseed Low Dose
criteria: 
gender: All
minimum age: 50 Years
maximum age: 65 Years
healthy volunteers: No
last name: Andrea Hutchins, PhD
role: Principal Investigator
affiliation: University of Colorado, Colorado Springs
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Colorado, Colorado Springs
investigator full name: Andrea Hutchins
investigator title: Associate Professor
mesh term: Prediabetic State