<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/NCT03036618</url>
  </required_header>
  <id_info>
    <org_study_id>NUHEALTH-LL01-Quinoa</org_study_id>
    <nct_id>NCT03036618</nct_id>
  </id_info>
  <brief_title>Effects of Quinoa Consumption on Markers of Cardiovascular Risk and Gastrointestinal Health</brief_title>
  <official_title>Effects of Quinoa Consumption on Markers of Cardiovascular Risk and Gastrointestinal Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Newcastle University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Newcastle University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Quinoa is possible alternative to wheat, corn and rice due to its high nutritional value and&#xD;
      possible properties against cardiovascular diseases and for improving gut health. There are&#xD;
      some animal studies to suggest that some important class of compounds like fibre,&#xD;
      antioxidants and protein, found naturally in quinoa, have beneficial effects against markers&#xD;
      of cardiovascular diseases. However, the effects of quinoa on humans has rarely been&#xD;
      investigated. This study will investigate the effects of daily consumption of quinoa for four&#xD;
      weeks on markers of cardiovascular risk, including blood cholesterol and resting blood&#xD;
      pressure, and on gut health in a randomised cross-over study design.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Quinoa is a possible alternative to wheat, corn and rice due to its high nutritional value&#xD;
      and possible properties against cardiovascular diseases. There are some animal studies which&#xD;
      suggest that quinoa has beneficial effects against markers of cardiovascular diseases,&#xD;
      particularly blood lipid profile. The grain has a unique nutritional profile, with high fibre&#xD;
      levels and a wide range of phytochemicals which may influence gut bacteria and improve&#xD;
      gastrointestinal health.&#xD;
&#xD;
      However, the effects of quinoa on humans has rarely been investigated with just two small&#xD;
      interventions published. These studies also showed an improvement in blood lipid profile&#xD;
      after consuming quinoa daily. There have been no studies which have investigated the effects&#xD;
      of quinoa on gut bacteria and gastrointestinal health. Therefore, this human dietary&#xD;
      intervention study aims to determine the effects of quinoa consumption on markers of&#xD;
      cardiovascular diseases, the gut microbiome and gastrointestinal health.&#xD;
&#xD;
      The study is a randomized cross-over designed dietary intervention study with 4-week study&#xD;
      periods separated by a 4-week wash-out period. The treatment will be the daily consumption of&#xD;
      a test bread roll containing quinoa to deliver 20g quinoa per day (one roll per day). The&#xD;
      control will be the same amount of a refined wheat roll. Markers of cardiovascular disease&#xD;
      risk, including fasting blood lipid profile, plasma glucose and insulin concentration,&#xD;
      resting blood pressure will be compared at the beginning and end of each treatment period.&#xD;
      Changes in the numbers and species of gut bacteria, and products of bacterial fermentation&#xD;
      will be made in stool samples collected at the beginning and end of each intervention period&#xD;
      as indicators of gastrointestinal health.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2016</start_date>
  <completion_date type="Anticipated">September 2018</completion_date>
  <primary_completion_date type="Anticipated">February 2017</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>plasma LDL-cholesterol</measure>
    <time_frame>Change from post dose after 4 weeks of intervention</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>BMI</measure>
    <time_frame>Change from post dose after 4 weeks of intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body fat</measure>
    <time_frame>Change from post dose after 4 weeks of intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>Change from post dose after 4 weeks of intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting Blood glucose and insulin</measure>
    <time_frame>Change from post dose after 4 weeks of intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting blood lipid profile</measure>
    <time_frame>Change from post dose after 4 weeks of intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stool Microbiome profile</measure>
    <time_frame>Change from post dose after 4 weeks of intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>short chain fatty acid profile of stool samples</measure>
    <time_frame>Change from post dose after 4 weeks of intervention</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Change in Fasting Plasma LDL-cholesterol Concentration After the Consumption of Quinoa</condition>
  <arm_group>
    <arm_group_label>Wheat</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Test wheat bread roll (approximately 160g weight) without quinoa.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Quinoa</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test wheat bread roll (approximately 160g weight) delivering 20 g quinoa consumed per day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Quinoa</intervention_name>
    <description>Test wheat bread roll (approximately 160g weight) delivering 20 g quinoa consumed per day.</description>
    <arm_group_label>Quinoa</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Wheat</intervention_name>
    <description>Test wheat bread roll (approximately 160g weight) without quinoa.</description>
    <arm_group_label>Wheat</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. healthy men &gt;35 years old&#xD;
&#xD;
          2. body mass index &gt;25 kg/m2&#xD;
&#xD;
          3. Non-smokers with no known previous history of cardiovascular disease or type 2&#xD;
             diabetes&#xD;
&#xD;
          4. Not receiving any current medication. Supplement users will be included but will be&#xD;
             asked to stop taking supplements for the duration of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age ≤ 35 or BMI ≤25&#xD;
&#xD;
          2. Smokers&#xD;
&#xD;
          3. Individuals with known or suspected allergy to wheat&#xD;
&#xD;
          4. Individuals with known history of cardiovascular diseases or type 2 diabetes&#xD;
&#xD;
          5. Individuals with recent weight loss (&gt;10%) or planning to lose weight during the study&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chris Seal, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Newcastle University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Liangkui Li</last_name>
    <email>l.li11@ncl.ac.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>NU-Food Research Facility</name>
      <address>
        <city>Newcastle upon Tyne</city>
        <state>Tyne and Wear</state>
        <zip>NE1 7RU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anthony Watson, PhD</last_name>
      <email>anthony.watson@ncl.ac.uk</email>
    </contact>
    <investigator>
      <last_name>Liangkui Li</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Chris Seal, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>January 26, 2017</last_update_submitted>
  <last_update_submitted_qc>January 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>BMI</keyword>
  <keyword>Blood Cholesterol</keyword>
  <keyword>Glucose</keyword>
  <keyword>Insulin</keyword>
  <keyword>Gut health</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03036618
org study id: NUHEALTH-LL01-Quinoa
nct id: NCT03036618
lead sponsor: 
has dmc: No
Quinoa is possible alternative to wheat, corn and rice due to its high nutritional value and
      possible properties against cardiovascular diseases and for improving gut health. There are
      some animal studies to suggest that some important class of compounds like fibre,
      antioxidants and protein, found naturally in quinoa, have beneficial effects against markers
      of cardiovascular diseases. However, the effects of quinoa on humans has rarely been
      investigated. This study will investigate the effects of daily consumption of quinoa for four
      weeks on markers of cardiovascular risk, including blood cholesterol and resting blood
      pressure, and on gut health in a randomised cross-over study design.
Quinoa is a possible alternative to wheat, corn and rice due to its high nutritional value
      and possible properties against cardiovascular diseases. There are some animal studies which
      suggest that quinoa has beneficial effects against markers of cardiovascular diseases,
      particularly blood lipid profile. The grain has a unique nutritional profile, with high fibre
      levels and a wide range of phytochemicals which may influence gut bacteria and improve
      gastrointestinal health.

      However, the effects of quinoa on humans has rarely been investigated with just two small
      interventions published. These studies also showed an improvement in blood lipid profile
      after consuming quinoa daily. There have been no studies which have investigated the effects
      of quinoa on gut bacteria and gastrointestinal health. Therefore, this human dietary
      intervention study aims to determine the effects of quinoa consumption on markers of
      cardiovascular diseases, the gut microbiome and gastrointestinal health.

      The study is a randomized cross-over designed dietary intervention study with 4-week study
      periods separated by a 4-week wash-out period. The treatment will be the daily consumption of
      a test bread roll containing quinoa to deliver 20g quinoa per day (one roll per day). The
      control will be the same amount of a refined wheat roll. Markers of cardiovascular disease
      risk, including fasting blood lipid profile, plasma glucose and insulin concentration,
      resting blood pressure will be compared at the beginning and end of each treatment period.
      Changes in the numbers and species of gut bacteria, and products of bacterial fermentation
      will be made in stool samples collected at the beginning and end of each intervention period
      as indicators of gastrointestinal health.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: plasma LDL-cholesterol
time frame: Change from post dose after 4 weeks of intervention
measure: BMI
time frame: Change from post dose after 4 weeks of intervention
measure: Body fat
time frame: Change from post dose after 4 weeks of intervention
measure: Blood pressure
time frame: Change from post dose after 4 weeks of intervention
measure: Fasting Blood glucose and insulin
time frame: Change from post dose after 4 weeks of intervention
measure: Fasting blood lipid profile
time frame: Change from post dose after 4 weeks of intervention
measure: Stool Microbiome profile
time frame: Change from post dose after 4 weeks of intervention
measure: short chain fatty acid profile of stool samples
time frame: Change from post dose after 4 weeks of intervention
arm group label: Wheat
arm group type: Placebo Comparator
description: Test wheat bread roll (approximately 160g weight) without quinoa.
arm group label: Quinoa
arm group type: Experimental
description: Test wheat bread roll (approximately 160g weight) delivering 20 g quinoa consumed per day.
intervention type: Dietary Supplement
intervention name: Quinoa
description: Test wheat bread roll (approximately 160g weight) delivering 20 g quinoa consumed per day.
arm group label: Quinoa
intervention type: Dietary Supplement
intervention name: Wheat
description: Test wheat bread roll (approximately 160g weight) without quinoa.
arm group label: Wheat
criteria: 
gender: Male
minimum age: 35 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Chris Seal, Professor
role: Principal Investigator
affiliation: Newcastle University
last name: Liangkui Li
email: l.li11@ncl.ac.uk
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: Undecided