<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/NCT03291548</url>
  </required_header>
  <id_info>
    <org_study_id>UREC/16/0106</org_study_id>
    <nct_id>NCT03291548</nct_id>
  </id_info>
  <brief_title>Quinoa Biscuit &amp; CVD Risk Trial</brief_title>
  <official_title>Effect of a Quinoa-enriched Biscuit as Novel Food Product to Improve CVD Risk Markers in Older Adults: a Randomised Crossover Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Ulster</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Regional Centre for Studies in Food and Health (CREAS), Valparaíso, Chile</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Ulster</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cardiovascular disease (CVD) is one of the most common chronic diseases in older populations,&#xD;
      which has been increasing in line with rising overweight and obesity levels in recent years.&#xD;
      Dietary intake is a major modifiable risk factor for CVD, and one such recommendation is to&#xD;
      increase the intake of essential (omega-3) polyunsaturated fats in our diets, for example by&#xD;
      consuming more oily fish. We know, however, from large population level dietary surveys, that&#xD;
      many individuals within the United Kingdom (UK) population are not consuming enough oily&#xD;
      fish. Therefore, alternative dietary sources of omega-3 polyunsaturated fats are required to&#xD;
      help meet consumer needs.&#xD;
&#xD;
      Quinoa is a traditional Andean seed crop consumed in a similar fashion to staple cereal&#xD;
      grains in Europe, and the popularity of quinoa has been growing worldwide because of its&#xD;
      nutritional content and perceived healthiness. Quinoa contains a small amount of fat, but the&#xD;
      ratio of omega-6 and omega-3 essential fats is more favourable in quinoa than in other plant&#xD;
      oils. An opportunity therefore exists to incorporate quinoa flour into more frequently&#xD;
      consumed food products (e.g. biscuits) as an alternative means of increasing consumers&#xD;
      omega-3 intake.&#xD;
&#xD;
      The purpose of this study is to investigate the effect of consuming quinoa-enriched biscuits,&#xD;
      compared to control, on markers of CVD risk over 4-weeks in older adults.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 13, 2017</start_date>
  <completion_date type="Actual">June 19, 2017</completion_date>
  <primary_completion_date type="Actual">June 19, 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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Double Blind: researcher and particiapant unaware of the intervention assignment</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Total cholesterol</measure>
    <time_frame>Change from baseline compared to control arm</time_frame>
    <description>Plasma cholesterol</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Triglycerides</measure>
    <time_frame>Change from baseline compared to control arm</time_frame>
    <description>measured in plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDL-cholesterol</measure>
    <time_frame>Change from baseline compared to control arm</time_frame>
    <description>measured in plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HDL-cholesterol</measure>
    <time_frame>Change from baseline compared to control arm</time_frame>
    <description>measured in plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>total/HDL-cholesterol ratio</measure>
    <time_frame>Change from baseline compared to control arm</time_frame>
    <description>measured in plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Poly-unsaturated fatty acid status</measure>
    <time_frame>Change from baseline compared to control arm</time_frame>
    <description>measured in plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antioxidant status</measure>
    <time_frame>Change from baseline compared to control arm</time_frame>
    <description>Ferric-reducing Ability Plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory status</measure>
    <time_frame>Change from baseline compared to control arm</time_frame>
    <description>C-reactive protein</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>Change from baseline compared to control arm</time_frame>
    <description>Diastolic and systolic</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>Change from baseline compared to control arm</time_frame>
    <description>Kg</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <condition>Dyslipidemias</condition>
  <condition>Lipid Profile</condition>
  <arm_group>
    <arm_group_label>Quinoa Biscuit</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The quinoa-enriched biscuits containing 7.11g quinoa flour.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control biscuit</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The placebo control biscuit: an iso-energetic, matched product in terms of appearance, taste, texture and smell.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Quinoa biscuit</intervention_name>
    <description>2x15g biscuits per day for 28 consecutive days (4 weeks).</description>
    <arm_group_label>Quinoa Biscuit</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Control biscuit</intervention_name>
    <description>2x15g biscuits per day for 28 consecutive days (4 weeks).</description>
    <arm_group_label>Control biscuit</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Free-living, apparently healthy adults&#xD;
&#xD;
          -  Aged 50-75 years at recruitment&#xD;
&#xD;
          -  Low fish consumers (&lt;2 servings/wk)&#xD;
&#xD;
          -  Non-smokers&#xD;
&#xD;
          -  Not regularly consuming plant stanols&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-free-living adults&#xD;
&#xD;
          -  Aged &lt;50 or &gt;75 years at recruitment&#xD;
&#xD;
          -  Fish consumers (2 servings/wk or more)&#xD;
&#xD;
          -  Current smokers&#xD;
&#xD;
          -  Pregnant/lactating females&#xD;
&#xD;
          -  Coeliac disease, wheat intolerance or any other food allergy or intolerance that would&#xD;
             prevent consumption of the biscuits&#xD;
&#xD;
          -  Currently taking any fish oil-containing supplement&#xD;
&#xD;
          -  Diagnosed with a chronic medical condition (such as diabetes; CVD autoimmune/&#xD;
             inflammatory disorders; cancer)&#xD;
&#xD;
          -  Prescribed cholesterol or blood pressure lowering medications&#xD;
&#xD;
          -  Daily consumption of plant stanols&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Human Intervention Studies Unit, Ulster University</name>
      <address>
        <city>Coleraine</city>
        <state>Londonderry</state>
        <zip>BT52 1SA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>September 19, 2017</last_update_submitted>
  <last_update_submitted_qc>September 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Quinoa</keyword>
  <keyword>Functional food</keyword>
  <keyword>Cardiovascular disease</keyword>
  <keyword>Cholesterol</keyword>
  <keyword>Lipid profile</keyword>
  <keyword>Randomised Control Trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Dyslipidemias</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03291548
org study id: UREC/16/0106
nct id: NCT03291548
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cardiovascular disease (CVD) is one of the most common chronic diseases in older populations,
      which has been increasing in line with rising overweight and obesity levels in recent years.
      Dietary intake is a major modifiable risk factor for CVD, and one such recommendation is to
      increase the intake of essential (omega-3) polyunsaturated fats in our diets, for example by
      consuming more oily fish. We know, however, from large population level dietary surveys, that
      many individuals within the United Kingdom (UK) population are not consuming enough oily
      fish. Therefore, alternative dietary sources of omega-3 polyunsaturated fats are required to
      help meet consumer needs.

      Quinoa is a traditional Andean seed crop consumed in a similar fashion to staple cereal
      grains in Europe, and the popularity of quinoa has been growing worldwide because of its
      nutritional content and perceived healthiness. Quinoa contains a small amount of fat, but the
      ratio of omega-6 and omega-3 essential fats is more favourable in quinoa than in other plant
      oils. An opportunity therefore exists to incorporate quinoa flour into more frequently
      consumed food products (e.g. biscuits) as an alternative means of increasing consumers
      omega-3 intake.

      The purpose of this study is to investigate the effect of consuming quinoa-enriched biscuits,
      compared to control, on markers of CVD risk over 4-weeks in older adults.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
masking description: Double Blind: researcher and particiapant unaware of the intervention assignment
measure: Total cholesterol
time frame: Change from baseline compared to control arm
description: Plasma cholesterol
measure: Triglycerides
time frame: Change from baseline compared to control arm
description: measured in plasma
measure: LDL-cholesterol
time frame: Change from baseline compared to control arm
description: measured in plasma
measure: HDL-cholesterol
time frame: Change from baseline compared to control arm
description: measured in plasma
measure: total/HDL-cholesterol ratio
time frame: Change from baseline compared to control arm
description: measured in plasma
measure: Poly-unsaturated fatty acid status
time frame: Change from baseline compared to control arm
description: measured in plasma
measure: Antioxidant status
time frame: Change from baseline compared to control arm
description: Ferric-reducing Ability Plasma
measure: Inflammatory status
time frame: Change from baseline compared to control arm
description: C-reactive protein
measure: Blood pressure
time frame: Change from baseline compared to control arm
description: Diastolic and systolic
measure: Weight
time frame: Change from baseline compared to control arm
description: Kg
arm group label: Quinoa Biscuit
arm group type: Experimental
description: The quinoa-enriched biscuits containing 7.11g quinoa flour.
arm group label: Control biscuit
arm group type: Placebo Comparator
description: The placebo control biscuit: an iso-energetic, matched product in terms of appearance, taste, texture and smell.
intervention type: Dietary Supplement
intervention name: Quinoa biscuit
description: 2x15g biscuits per day for 28 consecutive days (4 weeks).
arm group label: Quinoa Biscuit
intervention type: Dietary Supplement
intervention name: Control biscuit
description: 2x15g biscuits per day for 28 consecutive days (4 weeks).
arm group label: Control biscuit
criteria: 
gender: All
minimum age: 50 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
mesh term: Dyslipidemias
sharing ipd: No