<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/NCT02195934</url>
  </required_header>
  <id_info>
    <org_study_id>IFR03/2014</org_study_id>
    <secondary_id>14/EE/0219</secondary_id>
    <secondary_id>155431</secondary_id>
    <secondary_id>2014GP23</secondary_id>
    <nct_id>NCT02195934</nct_id>
  </id_info>
  <brief_title>The Orange Juice and Cardiovascular Disease Study</brief_title>
  <acronym>OJ &amp; CVD</acronym>
  <official_title>The Orange Juice and Cardiovascular Disease Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Quadram Institute Bioscience</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>European Commission</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Biotechnology and Biological Sciences Research Council</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Quadram Institute Bioscience</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to compare the effect of an anthocyanin-rich blood orange juice with a&#xD;
      standard (no anthocyanin) blonde orange juice on markers of cardiovascular disease (CVD).&#xD;
&#xD;
      Participants aged between 25 and 84 years of age will be recruited into a single arm, two way&#xD;
      cross-over study based on their waist measurement, with 42 individuals required to complete&#xD;
      the study. Participants will each receive two interventions in a randomised order: 500mL&#xD;
      blood orange juice daily for 28 days, and 500ml standard (blonde) orange juice daily for 28&#xD;
      days.&#xD;
&#xD;
      Prior to each intervention there will be a 2 week &quot;run in period&quot; where participants will be&#xD;
      asked to avoid consuming foods rich in anthocyanins. After the first 28 day intervention&#xD;
      period, there will be a 3 week wash out period after which the participants will be asked to&#xD;
      then drink the other juice for 28 days. The 500 mL of blood orange juice contains&#xD;
      approximately 50mg of anthocyanins, whereas the standard juice contains none.&#xD;
&#xD;
      Blood samples will be collected for the preparation of plasma and peripheral blood&#xD;
      mononuclear cells (PBMCs) for the analysis of anthocyanin metabolite concentrations,&#xD;
      transcriptomics and CVD risk markers. Urine samples will be collected and urinary excretion&#xD;
      of anthocyanin metabolites will be quantified. Other measurements will include pulse wave&#xD;
      analysis, pulse wave velocity, central blood pressure, waist and hip circumference, blood&#xD;
      glucose, glycated haemoglobin (HbA1C) and insulin concentrations, and various measurements&#xD;
      using the TANITA machine which include weight, fat mass, muscle mass, fat percentage,&#xD;
      fat-free mass, total body water, bone mass, metabolic age, basal metabolic rate, visceral fat&#xD;
      rating, and degree of obesity. All measurements and samples will be taken at baseline and&#xD;
      post intervention for each phase of the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>LDL cholesterol</measure>
    <time_frame>28 days (4 weeks)</time_frame>
    <description>The primary outcome measure will be the change in concentration of LDL cholesterol as a result of the daily consumption of standard (blonde) orange juice or blood orange juice for 28 days (4 weeks).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CVD biomarkers</measure>
    <time_frame>28 days (4 weeks)</time_frame>
    <description>The secondary outcome measure include measuring the change in concentration of levels of other markers of CVD, HDL, total cholesterol, nitrites, nitrates, nitrosols, interleukin 6, high sensitivity C reactive protein, Dglucose, insulin and endothelin 1 as a result of daily consumption of standard (blonde) orange juice or blood orange juice for 28 days (4 weeks).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Gene expression</measure>
    <time_frame>28 days (4 weeks)</time_frame>
    <description>The assessment of the activity of genes (gene expression) as a result of the daily consumption of standard (blonde) orange juice and blood orange juice for 28 days (4 weeks).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Cardiovascular Disease</condition>
  <arm_group>
    <arm_group_label>Standard orange juice (OJ) followed by blood OJ</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This randomized 2-way cross over study will compare the effect of blood orange juice with that of a standard (blonde) orange juice consumed daily for 28 days, on markers of cardiovascular disease, with a 3 week washout period in between.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Blood orange juice followed by standard OJ</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This randomized 2-way cross over study will compare the effect of blood orange juice with that of a standard (blonde) orange juice consumed daily for 28 days, on markers of cardiovascular disease, with a 3 week washout period in between.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard (blonde) orange juice</intervention_name>
    <description>Consumption of 500ml standard (blonde) orange juice daily for 28 days</description>
    <arm_group_label>Blood orange juice followed by standard OJ</arm_group_label>
    <arm_group_label>Standard orange juice (OJ) followed by blood OJ</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood orange juice</intervention_name>
    <description>Consumption of 500ml blood orange juice daily for 28 days</description>
    <arm_group_label>Blood orange juice followed by standard OJ</arm_group_label>
    <arm_group_label>Standard orange juice (OJ) followed by blood OJ</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women aged 25-84 years&#xD;
&#xD;
          -  Waist measurement&#xD;
&#xD;
               -  Caucasians: Men &gt; 102cm (40inches); Women &gt;88cm (34inches)&#xD;
&#xD;
               -  Asians: Men&gt; 90cm (35inches); Women 80cm (31inches)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those unable to give written informed consent&#xD;
&#xD;
          -  Those unwilling to provide general practitioner (GP) details&#xD;
&#xD;
          -  Regular prescribed medication that may affect study outcome. This will be assessed on&#xD;
             an individual basis-not including statins&#xD;
&#xD;
          -  Over-the-counter (non-prescribed) medication that may affect the study data. This will&#xD;
             be assessed on an individual basis.&#xD;
&#xD;
          -  Allergy to the test juice drink or the actual fruit itself&#xD;
&#xD;
          -  Chronic medical conditions requiring active treatment. This will be assessed on an&#xD;
             individual basis&#xD;
&#xD;
          -  Those already consuming blood orange juice, unless they are willing to discontinue&#xD;
             consumption for 2 weeks prior to starting the study.&#xD;
&#xD;
          -  Diagnosed diabetics;&#xD;
&#xD;
          -  Peri-menopausal women (defined as: when there is a permanent change in menstrual&#xD;
             cycle)&#xD;
&#xD;
          -  Women on hormone replacement therapy (HRT) for less than one year&#xD;
&#xD;
          -  On thyroxine for less than one year&#xD;
&#xD;
          -  Women who are pregnant, have been pregnant within the last 12 months or who are&#xD;
             breastfeeding&#xD;
&#xD;
          -  Those taking aspirin (prescribed or self-prescribed)&#xD;
&#xD;
          -  All blood pressure medication&#xD;
&#xD;
          -  Those individuals who happen to be on statins will be excluded if they have been on&#xD;
             statins for less than 3 months; or if they are not taking on a daily basis; or those&#xD;
             who have recently changed their dosage of statins. This will be assessed on an&#xD;
             individual basis&#xD;
&#xD;
          -  Those on regular medication for hypercoagulation and inflammatory conditions e.g.&#xD;
             corticosteroids and asthma. The intermittent use of an inhaler will be discussed on an&#xD;
             individual basis&#xD;
&#xD;
          -  Those who have had a cardiovascular event such as stroke, myocardial infarction (heart&#xD;
             attack) or trans ischemic attacks in the past and deemed unsuitable for participation&#xD;
             in the study. This will be discussed with the medical adviser on an individual basis&#xD;
&#xD;
          -  Peripheral vascular disease including claudication&#xD;
&#xD;
          -  Consumption of fish oil supplements (unless participant is willing to discontinue&#xD;
             their use 8 weeks prior to the start of the intervention- all other supplements will&#xD;
             be assessed on an individual basis&#xD;
&#xD;
          -  Parallel participation in another research project which has involved dietary&#xD;
             intervention and/or sampling of blood&#xD;
&#xD;
          -  Any person related to or living with any member of the study team&#xD;
&#xD;
          -  Participation in another research project which involves blood sampling within the&#xD;
             last four months unless the total blood from both studies (including this one) does&#xD;
             not exceed 470mL)&#xD;
&#xD;
          -  Those who have donated or intend to donate blood within 16 weeks of the first and last&#xD;
             study samples&#xD;
&#xD;
          -  Gastrointestinal disease (excluding hiatus hernia) unless symptomatic or study&#xD;
             intervention/procedure is contraindicated&#xD;
&#xD;
          -  Those undergoing any on-going clinical investigations with their GP or hospital&#xD;
             clinic.&#xD;
&#xD;
          -  Those who have had throat surgery or neck injury&#xD;
&#xD;
          -  Those with internal medical devices&#xD;
&#xD;
        Screening exclusion criteria&#xD;
&#xD;
          -  Results of the eligibility screening that indicate or are judged by the Institute of&#xD;
             Food Research Human Nutrition Unit (HNU) medical adviser to be indicative of a health&#xD;
             problem which could compromise the well-being of the participant if they participated&#xD;
             or could affect the study data.&#xD;
&#xD;
          -  BMI &lt;19.5&#xD;
&#xD;
          -  Weight &gt;180kg (28stones)&#xD;
&#xD;
          -  Fasting total cholesterol &gt; 8.0mmol/L&#xD;
&#xD;
          -  Haemoglobin Men &lt;13.8g/dL (8.56mmol/L) Women &lt;12.1g/dL (&lt;5.51mmol/L)&#xD;
&#xD;
          -  Fasting glucose &gt;6mmol/L&#xD;
&#xD;
          -  Blood pressure &lt;90/50mmHg or 95/55mmHg if symptomatic; &gt;160/100mmHg&#xD;
&#xD;
          -  Anyone with any internal medical devices (incompatible with the TANITA)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>84 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul A Kroon, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Quadram Institute Bioscience</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Charlotte N Armah, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Quadram Institute Bioscience</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Joanne F Doleman, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Quadram Institute Bioscience</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute of Food Research</name>
      <address>
        <city>Norwich</city>
        <state>Norfolk</state>
        <zip>NR4 7UA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>September 2, 2016</last_update_submitted>
  <last_update_submitted_qc>September 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cardiovascular disease, blood orange juice, anthocyanins</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</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/NCT02195934
org study id: IFR03/2014
secondary id: 14/EE/0219
secondary id: 155431
secondary id: 2014GP23
nct id: NCT02195934
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This study aims to compare the effect of an anthocyanin-rich blood orange juice with a
      standard (no anthocyanin) blonde orange juice on markers of cardiovascular disease (CVD).

      Participants aged between 25 and 84 years of age will be recruited into a single arm, two way
      cross-over study based on their waist measurement, with 42 individuals required to complete
      the study. Participants will each receive two interventions in a randomised order: 500mL
      blood orange juice daily for 28 days, and 500ml standard (blonde) orange juice daily for 28
      days.

      Prior to each intervention there will be a 2 week "run in period" where participants will be
      asked to avoid consuming foods rich in anthocyanins. After the first 28 day intervention
      period, there will be a 3 week wash out period after which the participants will be asked to
      then drink the other juice for 28 days. The 500 mL of blood orange juice contains
      approximately 50mg of anthocyanins, whereas the standard juice contains none.

      Blood samples will be collected for the preparation of plasma and peripheral blood
      mononuclear cells (PBMCs) for the analysis of anthocyanin metabolite concentrations,
      transcriptomics and CVD risk markers. Urine samples will be collected and urinary excretion
      of anthocyanin metabolites will be quantified. Other measurements will include pulse wave
      analysis, pulse wave velocity, central blood pressure, waist and hip circumference, blood
      glucose, glycated haemoglobin (HbA1C) and insulin concentrations, and various measurements
      using the TANITA machine which include weight, fat mass, muscle mass, fat percentage,
      fat-free mass, total body water, bone mass, metabolic age, basal metabolic rate, visceral fat
      rating, and degree of obesity. All measurements and samples will be taken at baseline and
      post intervention for each phase of the study.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: LDL cholesterol
time frame: 28 days (4 weeks)
description: The primary outcome measure will be the change in concentration of LDL cholesterol as a result of the daily consumption of standard (blonde) orange juice or blood orange juice for 28 days (4 weeks).
measure: CVD biomarkers
time frame: 28 days (4 weeks)
description: The secondary outcome measure include measuring the change in concentration of levels of other markers of CVD, HDL, total cholesterol, nitrites, nitrates, nitrosols, interleukin 6, high sensitivity C reactive protein, Dglucose, insulin and endothelin 1 as a result of daily consumption of standard (blonde) orange juice or blood orange juice for 28 days (4 weeks).
measure: Gene expression
time frame: 28 days (4 weeks)
description: The assessment of the activity of genes (gene expression) as a result of the daily consumption of standard (blonde) orange juice and blood orange juice for 28 days (4 weeks).
arm group label: Standard orange juice (OJ) followed by blood OJ
arm group type: Other
description: This randomized 2-way cross over study will compare the effect of blood orange juice with that of a standard (blonde) orange juice consumed daily for 28 days, on markers of cardiovascular disease, with a 3 week washout period in between.
arm group label: Blood orange juice followed by standard OJ
arm group type: Other
description: This randomized 2-way cross over study will compare the effect of blood orange juice with that of a standard (blonde) orange juice consumed daily for 28 days, on markers of cardiovascular disease, with a 3 week washout period in between.
intervention type: Other
intervention name: Standard (blonde) orange juice
description: Consumption of 500ml standard (blonde) orange juice daily for 28 days
arm group label: Blood orange juice followed by standard OJ
arm group label: Standard orange juice (OJ) followed by blood OJ
intervention type: Other
intervention name: Blood orange juice
description: Consumption of 500ml blood orange juice daily for 28 days
arm group label: Blood orange juice followed by standard OJ
arm group label: Standard orange juice (OJ) followed by blood OJ
criteria: 
gender: All
minimum age: 25 Years
maximum age: 84 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Paul A Kroon, PhD
role: Study Director
affiliation: Quadram Institute Bioscience
last name: Charlotte N Armah, PhD
role: Principal Investigator
affiliation: Quadram Institute Bioscience
last name: Joanne F Doleman, PhD
role: Principal Investigator
affiliation: Quadram Institute Bioscience
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Cardiovascular Diseases