<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/NCT01706042</url>
  </required_header>
  <id_info>
    <org_study_id>668/2008</org_study_id>
    <nct_id>NCT01706042</nct_id>
  </id_info>
  <brief_title>Effects of Legumes on Glucose Regulation</brief_title>
  <official_title>Over-night Metabolic Effects of Legumes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lund University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Anti-Diabetic Food Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Lund University</source>
  <brief_summary>
    <textblock>
      Dietary prevention strategies are increasingly recognized as essential to combat the current&#xD;
      epidemic of obesity and related metabolic disorders. The purpose of the present study was to&#xD;
      evaluate the potential effects of legumes in relation to cardiometabolic risk markers and&#xD;
      appetite regulating hormones.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2010</start_date>
  <completion_date type="Actual">August 2011</completion_date>
  <primary_completion_date type="Actual">August 2010</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</measure>
    <time_frame>11 hours</time_frame>
    <description>A portion of legumes or bread was consumed as a late evening meal, blood glucose was measured the next morning at breakfast.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>satiety</measure>
    <time_frame>11 hours</time_frame>
    <description>legumes or bread was consumed as a late evening meal, satiety hormones (PYY, oxyntomodulin)and appetite sensations were determined at a following breakfast.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>inflammatory markers</measure>
    <time_frame>11 hours</time_frame>
    <description>legumes or bread was consumed as a late evening meal, inflammatory markers (IL-6, IL-8)was determined at a following breakfast.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Dietary Prevention</condition>
  <arm_group>
    <arm_group_label>white bread</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>White bread (based on 35 g available carbohydrates)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Legume meal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Legumes are consumed as a late evening meal(based on 35 g available carbohydrates)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>legume meal</intervention_name>
    <arm_group_label>Legume meal</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>white bread</intervention_name>
    <arm_group_label>white bread</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy subjects between 20-35 years&#xD;
&#xD;
          -  With normal BMI and&#xD;
&#xD;
          -  No known metabolic- or gastro intestinal disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI &gt; 25,&#xD;
&#xD;
          -  Known metabolic disorder or&#xD;
&#xD;
          -  Gastrointestinal problems or disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Applied Nutrition and Food Chemistry, Lund University</name>
      <address>
        <city>Lund</city>
        <zip>SE-22100</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <reference>
    <citation>Sievenpiper JL, Kendall CW, Esfahani A, Wong JM, Carleton AJ, Jiang HY, Bazinet RP, Vidgen E, Jenkins DJ. Effect of non-oil-seed pulses on glycaemic control: a systematic review and meta-analysis of randomised controlled experimental trials in people with and without diabetes. Diabetologia. 2009 Aug;52(8):1479-95. doi: 10.1007/s00125-009-1395-7. Epub 2009 Jun 13.</citation>
    <PMID>19526214</PMID>
  </reference>
  <reference>
    <citation>Papanikolaou Y, Fulgoni VL 3rd. Bean consumption is associated with greater nutrient intake, reduced systolic blood pressure, lower body weight, and a smaller waist circumference in adults: results from the National Health and Nutrition Examination Survey 1999-2002. J Am Coll Nutr. 2008 Oct;27(5):569-76. doi: 10.1080/07315724.2008.10719740.</citation>
    <PMID>18845707</PMID>
  </reference>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>October 12, 2012</last_update_submitted>
  <last_update_submitted_qc>October 12, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 2012</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>assistant lector</investigator_title>
  </responsible_party>
  <!-- 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/NCT01706042
org study id: 668/2008
nct id: NCT01706042
lead sponsor: 
collaborator: 
Dietary prevention strategies are increasingly recognized as essential to combat the current
      epidemic of obesity and related metabolic disorders. The purpose of the present study was to
      evaluate the potential effects of legumes in relation to cardiometabolic risk markers and
      appetite regulating hormones.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: blood glucose
time frame: 11 hours
description: A portion of legumes or bread was consumed as a late evening meal, blood glucose was measured the next morning at breakfast.
measure: satiety
time frame: 11 hours
description: legumes or bread was consumed as a late evening meal, satiety hormones (PYY, oxyntomodulin)and appetite sensations were determined at a following breakfast.
measure: inflammatory markers
time frame: 11 hours
description: legumes or bread was consumed as a late evening meal, inflammatory markers (IL-6, IL-8)was determined at a following breakfast.
arm group label: white bread
arm group type: Placebo Comparator
description: White bread (based on 35 g available carbohydrates)
arm group label: Legume meal
arm group type: Active Comparator
description: Legumes are consumed as a late evening meal(based on 35 g available carbohydrates)
intervention type: Other
intervention name: legume meal
arm group label: Legume meal
intervention type: Other
intervention name: white bread
arm group label: white bread
criteria: 
gender: All
minimum age: 20 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Sweden
citation: Sievenpiper JL, Kendall CW, Esfahani A, Wong JM, Carleton AJ, Jiang HY, Bazinet RP, Vidgen E, Jenkins DJ. Effect of non-oil-seed pulses on glycaemic control: a systematic review and meta-analysis of randomised controlled experimental trials in people with and without diabetes. Diabetologia. 2009 Aug;52(8):1479-95. doi: 10.1007/s00125-009-1395-7. Epub 2009 Jun 13.
PMID: 19526214
citation: Papanikolaou Y, Fulgoni VL 3rd. Bean consumption is associated with greater nutrient intake, reduced systolic blood pressure, lower body weight, and a smaller waist circumference in adults: results from the National Health and Nutrition Examination Survey 1999-2002. J Am Coll Nutr. 2008 Oct;27(5):569-76. doi: 10.1080/07315724.2008.10719740.
PMID: 18845707
responsible party type: Principal Investigator
investigator affiliation: Lund University
investigator full name: Anne Nilsson
investigator title: assistant lector