<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/NCT02987595</url>
  </required_header>
  <id_info>
    <org_study_id>SwedishUAS</org_study_id>
    <nct_id>NCT02987595</nct_id>
  </id_info>
  <brief_title>Effects of Lignan-rich Diet on Cardiometabolic Risk Factors</brief_title>
  <official_title>Effects of Lignan-rich Diet on Cardiometabolic Risk Factors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Swedish University of Agricultural Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Swedish University of Agricultural Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diet plays an important role in relation to prevention of type 2 diabetes, cardiovascular&#xD;
      disease and certain cancers. Studies have shown that diets with high whole-grain content&#xD;
      could decrease the risk of these lifestyle related diseases and in Sweden the national&#xD;
      dietary guidelines recommends whole-grain based instead of refined cereal products. It is,&#xD;
      however, not clear whether whole-grain from wheat and rye share similar protective effects&#xD;
      since there are large differences in amount and quality of dietary fibre and associated&#xD;
      bioactive compounds. The aim of this study is to evaluate the impact of a wholegrain diet&#xD;
      with low- or high lignan content on different cardiometabolic risk factors with the primary&#xD;
      endpoint being blood glucose levels after 2h oral glucose tolerance test in men with&#xD;
      metabolic syndrome or sign thereof.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be conducted in a randomized, cross-over design (8 wk intervention periods).&#xD;
      The lignan-rich diet will be based on whole-grain rye products whereas the control diet will&#xD;
      be based on whole-grain wheat products with some added wheat bran. Both diets will provide&#xD;
      similar amount of whole grain (g/d) and total dietary fiber content (but dietary fibre&#xD;
      quality will be different). Although rye has high lignan content, the aim is to further&#xD;
      increase the lignan intake half-way through the whole grain rye intervention period. This&#xD;
      will allow us to distinguish the effect of lignans from the effect of whole grain rye as well&#xD;
      as evaluating potential differences in effects on cardiometabolic risk factors between whole&#xD;
      grain wheat and whole grain rye intake after 4-week consumption. The study design will also&#xD;
      allow us to investigate the effects of a putative interaction between microbiome x lignan&#xD;
      rich diet and its implication of metabolic risk factors.&#xD;
&#xD;
      Blood samples will be collected by trained nurses at screening, baseline, after 4 weeks and 8&#xD;
      weeks of first intervention period, after wash-out (8 weeks), and after 4 weeks and 8 weeks&#xD;
      of the second intervention period.&#xD;
&#xD;
      At each examination day participants will arrive to the test laboratory for blood samples and&#xD;
      an oral glucose tolerance test (OGTT) where participants will be given a drink with 75 g of&#xD;
      glucose to consume within 10 minutes. Blood samples will be taken after 30, 60 and 120&#xD;
      minutes. Furthermore, participants will be instructed to complete one 3-day weighted food&#xD;
      record and also to collect 24-h urine and a fecal sample at week 0, 4, 8, 16, 20 and 24.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2015</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood glucose levels</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood lipids</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory markers</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxidative stress markers</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Enterolignans in blood and urine</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Metabolic Syndrome</condition>
  <condition>Overweight</condition>
  <condition>Central Obesity</condition>
  <condition>Impaired Glucose Tolerance</condition>
  <arm_group>
    <arm_group_label>Whole-grain rye then wheat</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Whole-grain rye, high lignan Whole-grain rye products for 8 weeks, then a wash-out period of 8 weeks, and then whole-grain wheat products for 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Whole-grain wheat then rye</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Whole-grain wheat, low lignan Whole-grain wheat products for 8 weeks, then a wash-out period of 8 weeks, and then whole-grain rye products for 8 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Whole-grain rye, high lignan</intervention_name>
    <description>Intervention week 1-8: 50 g rolled rye + 50 g puffs + 4 pieces of crisp bread + 70 g pasta. Additionally for intervention week 4-8: 4 lignan capsules per day</description>
    <arm_group_label>Whole-grain rye then wheat</arm_group_label>
    <arm_group_label>Whole-grain wheat then rye</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Whole-grain wheat, low lignan</intervention_name>
    <description>Intervention week 1-8: 100 g puffs + 4 pieces of crisp bread + 70 g pasta.</description>
    <arm_group_label>Whole-grain rye then wheat</arm_group_label>
    <arm_group_label>Whole-grain wheat then rye</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI &gt; 25 kg/m2&#xD;
&#xD;
          -  waist circumference &gt; 102 cm&#xD;
&#xD;
          -  at least one of the following: blood pressure &gt;130/85 mmHg, serum triglycerides ≥1.69&#xD;
             mmol/L; HDL cholesterol &lt;1.04 mmol/L; or serum glucose ≥6.1 mmol/L&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  smokers&#xD;
&#xD;
          -  antibiotic use past 6 months&#xD;
&#xD;
          -  cancer diagnose (past 5 years) or other chronic disease diagnosis&#xD;
&#xD;
          -  excessive alcohol consumption (&gt;21 units/week)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rikard Landberg</last_name>
    <role>Principal Investigator</role>
    <affiliation>Swedish University of Agricultural Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Paediatric Research Facility; The Children's Hospital at Uppsala University Hospital</name>
      <address>
        <city>Uppsala</city>
        <zip>SE-751 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>June 16, 2015</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>December 6, 2016</last_update_submitted>
  <last_update_submitted_qc>December 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 9, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Swedish University of Agricultural Sciences</investigator_affiliation>
    <investigator_full_name>Dr. Rikard Landberg</investigator_full_name>
    <investigator_title>Associate professor, Head of Unit Food and Health, Department of Food Science, Swedish University of Agricultural Sciences (SLU)</investigator_title>
  </responsible_party>
  <keyword>intervention</keyword>
  <keyword>lignans</keyword>
  <keyword>whole-grain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Glucose Intolerance</mesh_term>
    <mesh_term>Obesity, Abdominal</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/NCT02987595
org study id: SwedishUAS
nct id: NCT02987595
lead sponsor: 
has dmc: No
Diet plays an important role in relation to prevention of type 2 diabetes, cardiovascular
      disease and certain cancers. Studies have shown that diets with high whole-grain content
      could decrease the risk of these lifestyle related diseases and in Sweden the national
      dietary guidelines recommends whole-grain based instead of refined cereal products. It is,
      however, not clear whether whole-grain from wheat and rye share similar protective effects
      since there are large differences in amount and quality of dietary fibre and associated
      bioactive compounds. The aim of this study is to evaluate the impact of a wholegrain diet
      with low- or high lignan content on different cardiometabolic risk factors with the primary
      endpoint being blood glucose levels after 2h oral glucose tolerance test in men with
      metabolic syndrome or sign thereof.
The study will be conducted in a randomized, cross-over design (8 wk intervention periods).
      The lignan-rich diet will be based on whole-grain rye products whereas the control diet will
      be based on whole-grain wheat products with some added wheat bran. Both diets will provide
      similar amount of whole grain (g/d) and total dietary fiber content (but dietary fibre
      quality will be different). Although rye has high lignan content, the aim is to further
      increase the lignan intake half-way through the whole grain rye intervention period. This
      will allow us to distinguish the effect of lignans from the effect of whole grain rye as well
      as evaluating potential differences in effects on cardiometabolic risk factors between whole
      grain wheat and whole grain rye intake after 4-week consumption. The study design will also
      allow us to investigate the effects of a putative interaction between microbiome x lignan
      rich diet and its implication of metabolic risk factors.

      Blood samples will be collected by trained nurses at screening, baseline, after 4 weeks and 8
      weeks of first intervention period, after wash-out (8 weeks), and after 4 weeks and 8 weeks
      of the second intervention period.

      At each examination day participants will arrive to the test laboratory for blood samples and
      an oral glucose tolerance test (OGTT) where participants will be given a drink with 75 g of
      glucose to consume within 10 minutes. Blood samples will be taken after 30, 60 and 120
      minutes. Furthermore, participants will be instructed to complete one 3-day weighted food
      record and also to collect 24-h urine and a fecal sample at week 0, 4, 8, 16, 20 and 24.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Blood glucose levels
time frame: 8 weeks
measure: Blood lipids
time frame: 8 weeks
measure: Inflammatory markers
time frame: 8 weeks
measure: Oxidative stress markers
time frame: 8 weeks
measure: Enterolignans in blood and urine
time frame: 8 weeks
arm group label: Whole-grain rye then wheat
arm group type: Experimental
description: Whole-grain rye, high lignan Whole-grain rye products for 8 weeks, then a wash-out period of 8 weeks, and then whole-grain wheat products for 8 weeks
arm group label: Whole-grain wheat then rye
arm group type: Experimental
description: Whole-grain wheat, low lignan Whole-grain wheat products for 8 weeks, then a wash-out period of 8 weeks, and then whole-grain rye products for 8 weeks
intervention type: Other
intervention name: Whole-grain rye, high lignan
description: Intervention week 1-8: 50 g rolled rye + 50 g puffs + 4 pieces of crisp bread + 70 g pasta. Additionally for intervention week 4-8: 4 lignan capsules per day
arm group label: Whole-grain rye then wheat
arm group label: Whole-grain wheat then rye
intervention type: Other
intervention name: Whole-grain wheat, low lignan
description: Intervention week 1-8: 100 g puffs + 4 pieces of crisp bread + 70 g pasta.
arm group label: Whole-grain rye then wheat
arm group label: Whole-grain wheat then rye
criteria: 
gender: Male
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rikard Landberg
role: Principal Investigator
affiliation: Swedish University of Agricultural Sciences
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Swedish University of Agricultural Sciences
investigator full name: Dr. Rikard Landberg
investigator title: Associate professor, Head of Unit Food and Health, Department of Food Science, Swedish University of Agricultural Sciences (SLU)
mesh term: Overweight
mesh term: Metabolic Syndrome
mesh term: Glucose Intolerance
mesh term: Obesity, Abdominal