<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/NCT02246985</url>
  </required_header>
  <id_info>
    <org_study_id>14/HSMC/2010</org_study_id>
    <nct_id>NCT02246985</nct_id>
  </id_info>
  <brief_title>Bioavailability of Carotenoids Added Into Processed Foods</brief_title>
  <acronym>CAROTFoods</acronym>
  <official_title>Bioavailability of Carotenoids Incorporated Into Processed Foods: Bread and Mayonnaise</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aberdeen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Aberdeen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Carotenoids are a family of pigments found abundantly in fruits and vegetables. They are&#xD;
      responsible for the colour of many fruits and vegetables such as tomatoes, melon, peppers and&#xD;
      orange coloured fruits and vegetables. Carotenoids such as beta-carotene are important for&#xD;
      the human body as precursors of vitamin A. They are also thought to be important as&#xD;
      anti-oxidants and may help protect against cancer and heart disease. Although many foods are&#xD;
      rich sources of carotenoids poor bioavailability often limits the amounts that are absorbed&#xD;
      and available for metabolism in humans.&#xD;
&#xD;
      Devising practical ways and means of increasing carotenoid bioavailability could lead to&#xD;
      better health outcomes. Processed foods are now widely eaten by many, both for their taste&#xD;
      and convenience. No studies have thus far looked at the bioavailability of carotenoids that&#xD;
      have been added into processed foods. Thus the purpose of this study is to investigate the&#xD;
      bioavailability of carotenoids that have been incorporated into processed food products&#xD;
      (bread and mayonnaise).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Carotenoids are a diverse group of natural-occurring fat-soluble pigments. Whilst over 600&#xD;
      different types have been characterised around 20 have been found in human tissue in the&#xD;
      postprandial state, however, over 90% of these absorbed carotenoids are made up of 6 specific&#xD;
      types (alpha-Carotene, beta-carotene, Lycopene, Lutein, Zeaxanthin and Cryptoxanthin)&#xD;
&#xD;
      There is good evidence to suggest that carotenoids play a notable role in human health both&#xD;
      through their pro-vitamin activity and as biological antioxidants. Carotenoids are believed&#xD;
      to be responsible for the beneficial effects of fruits and vegetables in preventing human&#xD;
      chronic diseases such as cancer and cardiovascular disease. Increasing fruit and vegetables&#xD;
      intakes in individuals can sometimes be difficult and unsustainable, therefore, increasing&#xD;
      bioavailability may be an effective alternative approach to maximise health outcomes.&#xD;
&#xD;
      A notable number of vegetables are rich sources of carotenoids, however, the amounts&#xD;
      available to the human body for metabolism are often small due to poor bioavailability. For&#xD;
      instance, studies have shown that bioavailability of carotenoids from carrots and tomatoes&#xD;
      can be as low as 1-3%. The bioavailability of carotenoids has been shown to depend on factors&#xD;
      such as their source, degree of cooking, processing, mechanical breakdown, presence of fat&#xD;
      and interactions between carotenoids. Whilst the presence of fat significantly increases&#xD;
      carotenoid absorption, the oil type, quantity and form it is in all affect bioavailability.&#xD;
&#xD;
      Recent work suggests that carotenoid bioavailability improves when fat is present in the form&#xD;
      of mayonnaise rather than as plain oil. This may be due to the emulsion properties of&#xD;
      mayonnaise which allows better solubilisation of amphiphilic compounds such as carotenoids.&#xD;
      Mayonnaise has also been shown to be more miscible in gastric juices (compared to plain oil)&#xD;
      and this too may be contributing to the greater absorption of carotenoids.&#xD;
&#xD;
      The present study builds upon this previous work and studies carotenoid bioavailability in&#xD;
      processed food systems. Using a bread-mayonnaise meal the study compares carotenoid&#xD;
      bioavailability when it is incorporated either into the bread or the mayonnaise. Furthermore,&#xD;
      the study investigates the impact of mayonnaise on the bioavailability of carotenoids&#xD;
      incorporated into a processed food (bread). The study will focus on the bioavailability of&#xD;
      three principle carotenoids found in foods, alpha-carotene, beta-carotene and lycopene.&#xD;
      Carrot and tomato are used as the sources of carotenoids.&#xD;
&#xD;
      HYPOTHESIS Carotenoid bioavailability is influenced by the food matrix in which they are&#xD;
      contained.&#xD;
&#xD;
      OBJECTIVES&#xD;
&#xD;
        1. To compare the acute-phase bioavailability (systemic and gut absorption) of targeted&#xD;
           carotenoids (alpha-carotene, beta-carotene and lycopene) when they are incorporated into&#xD;
           the different processed food matrices (bread and mayonnaise)&#xD;
&#xD;
        2. Study how mayonnaise affects the acute bioavailability of carotenoids incorporated into&#xD;
           a processed food.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">March 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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Carotenoid concentrations in plasma and in chylomicron-rich fraction</measure>
    <time_frame>At baseline, at every hour for up to 8 hours postprandial and at 24hours after test meal</time_frame>
    <description>Carotenoids in plasma and in the chylomicron-rich fraction will be measured using reverse-phase HPLC</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in carotenoid concentration in urine</measure>
    <time_frame>at baseline and at every hour for up to 8 hours post-prandial and at 24hours after test meal</time_frame>
    <description>Carotenoids in urine will be measured using reverse-phase HPLC</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Measurement of plasma retinol and retinyl ester concentrations</measure>
    <time_frame>at baseline and at every hour for up to 8 hours post-prandial and at 24 hours after the test meal</time_frame>
    <description>Plasma retinol and retinyl ester concentrations will be measured using reverse-phase HPLC</description>
  </other_outcome>
  <other_outcome>
    <measure>Plasma cholesterol concentrations</measure>
    <time_frame>At baseline and at every hour for up to 8 hours post-prandial and at 24hours after the test meal</time_frame>
    <description>Plasma cholesterol concentrations will be measured using reverse-phase HPLC</description>
  </other_outcome>
  <other_outcome>
    <measure>Satiety and palatability of test meals</measure>
    <time_frame>immediately before and after consumption of test meals</time_frame>
    <description>Measured using 100mm continuous-line visual analogue scales anchored at each end with opposing answers to satiety and palatability related questions</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Cardiovascular Disease</condition>
  <arm_group>
    <arm_group_label>Plain bread with plain mayonnaise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Control meal. The bread and mayonnaise in this meal does not have vegetable powders incorporated into them, hence this meal does not contain carotenoids</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vegetable bread only</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A vegetable powder (carrot and tomato) containing bread portion will be served alone. The amount of vegetable powder in the bread will be standardised to contain a known amount of carotenoids</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vegetable bread with plain mayonnaise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A vegetable powder (carrot and tomato) containing bread portion will be served with plain mayonnaise. The amount of vegetable powder in the bread will be standardised to contain a known amount of carotenoids.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Plain bread with vegetable mayonnaise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Plain bread will be served with a vegetable powder (carrot and tomato) containing mayonnaise. The amount of vegetable powder in the mayonnaise will be standardised to contain a known amount of carotenoids.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>The bread and mayonnaise in this meal does not have vegetable powders incorporated into them. Hence this meal does not contain carotenoids.</description>
    <arm_group_label>Plain bread with plain mayonnaise</arm_group_label>
    <other_name>plain bread with plain mayonnaise</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vegetable bread only</intervention_name>
    <description>A vegetable powder (carrot and tomato) containing bread portion will be served alone. The amount of vegetable powder in the bread portion will be standardised to contain a known amount of carotenoids.</description>
    <arm_group_label>Vegetable bread only</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Plain bread with vegetable mayonnaise</intervention_name>
    <description>Plain bread will be served with a vegetable powder (carrot and tomato) containing mayonnaise. The amount of vegetable powder in the mayonnaise will be standardised to contain a known amount of carotenoids.</description>
    <arm_group_label>Plain bread with vegetable mayonnaise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vegetable bread with plain mayonnaise</intervention_name>
    <description>A vegetable powder (Carrot and tomato) containing bread portion will be served with plain mayonnaise. The amount of vegetable powder in the bread portion will be standardised to contain a known amount of carotenoids</description>
    <arm_group_label>Vegetable bread with plain mayonnaise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy males and females Aged between 18 and 75 years. Body mass index between 18.5 -&#xD;
             40 kg/m2. Blood pressure equal to or less than 139/89 mmHG. HbA1C less than or equal&#xD;
             to 6.5%. Total blood cholesterol less than 6.0mmol/l&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suffering from Diabetes, kidney disease, hepatic disease, gout, gastrointestinal&#xD;
             disorder, thromboembolic or coagulation disease, hypertension, thyroid disorder or&#xD;
             hypercholesterolaemia On prescription medications Orlistat, Digoxin, Anti-arrhythmics,&#xD;
             tricyclic anti-depressants, neuroleptics, oral anti-diabetic medication, insulin,&#xD;
             anti-inflammatories, anti-pyretics and Statins Allergic/Intolerant to any of the foods&#xD;
             in the study Vegetarian or Vegan Restricted eating and/or eating disorders Alcohol&#xD;
             and/or substance abuse Regularly take nutritional supplements (once a day) Smoking&#xD;
             Poor venous access and veins difficult to cannulate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Viren Ranawana, Msc, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rowett Institute of Nutrition &amp; Health, University of Aberdeen, Greenburn Road, Bucksburn, Aberdeen,, United Kingdom AB21 9SB</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rowett Institute of Nutrition and Health, Human Nutrition Unit</name>
      <address>
        <city>Aberdeen</city>
        <zip>AB21 9SB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 23, 2014</study_first_posted>
  <last_update_submitted>February 24, 2017</last_update_submitted>
  <last_update_submitted_qc>February 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Processed foods</keyword>
  <keyword>Carotenoids in plasma, urine and faeces</keyword>
  <keyword>alpha-carotene</keyword>
  <keyword>beta-carotene</keyword>
  <keyword>Vitamin A</keyword>
  <keyword>Lycopene</keyword>
  <keyword>Gut absorption</keyword>
  <keyword>Bread</keyword>
  <keyword>Mayonnaise</keyword>
  <keyword>Bioavailability</keyword>
  <keyword>Fruits and Vegetables</keyword>
  <keyword>Inflammation</keyword>
  <keyword>Oxidative Stress</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</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/NCT02246985
org study id: 14/HSMC/2010
nct id: NCT02246985
lead sponsor: 
has dmc: No
Carotenoids are a family of pigments found abundantly in fruits and vegetables. They are
      responsible for the colour of many fruits and vegetables such as tomatoes, melon, peppers and
      orange coloured fruits and vegetables. Carotenoids such as beta-carotene are important for
      the human body as precursors of vitamin A. They are also thought to be important as
      anti-oxidants and may help protect against cancer and heart disease. Although many foods are
      rich sources of carotenoids poor bioavailability often limits the amounts that are absorbed
      and available for metabolism in humans.

      Devising practical ways and means of increasing carotenoid bioavailability could lead to
      better health outcomes. Processed foods are now widely eaten by many, both for their taste
      and convenience. No studies have thus far looked at the bioavailability of carotenoids that
      have been added into processed foods. Thus the purpose of this study is to investigate the
      bioavailability of carotenoids that have been incorporated into processed food products
      (bread and mayonnaise).
Carotenoids are a diverse group of natural-occurring fat-soluble pigments. Whilst over 600
      different types have been characterised around 20 have been found in human tissue in the
      postprandial state, however, over 90% of these absorbed carotenoids are made up of 6 specific
      types (alpha-Carotene, beta-carotene, Lycopene, Lutein, Zeaxanthin and Cryptoxanthin)

      There is good evidence to suggest that carotenoids play a notable role in human health both
      through their pro-vitamin activity and as biological antioxidants. Carotenoids are believed
      to be responsible for the beneficial effects of fruits and vegetables in preventing human
      chronic diseases such as cancer and cardiovascular disease. Increasing fruit and vegetables
      intakes in individuals can sometimes be difficult and unsustainable, therefore, increasing
      bioavailability may be an effective alternative approach to maximise health outcomes.

      A notable number of vegetables are rich sources of carotenoids, however, the amounts
      available to the human body for metabolism are often small due to poor bioavailability. For
      instance, studies have shown that bioavailability of carotenoids from carrots and tomatoes
      can be as low as 1-3%. The bioavailability of carotenoids has been shown to depend on factors
      such as their source, degree of cooking, processing, mechanical breakdown, presence of fat
      and interactions between carotenoids. Whilst the presence of fat significantly increases
      carotenoid absorption, the oil type, quantity and form it is in all affect bioavailability.

      Recent work suggests that carotenoid bioavailability improves when fat is present in the form
      of mayonnaise rather than as plain oil. This may be due to the emulsion properties of
      mayonnaise which allows better solubilisation of amphiphilic compounds such as carotenoids.
      Mayonnaise has also been shown to be more miscible in gastric juices (compared to plain oil)
      and this too may be contributing to the greater absorption of carotenoids.

      The present study builds upon this previous work and studies carotenoid bioavailability in
      processed food systems. Using a bread-mayonnaise meal the study compares carotenoid
      bioavailability when it is incorporated either into the bread or the mayonnaise. Furthermore,
      the study investigates the impact of mayonnaise on the bioavailability of carotenoids
      incorporated into a processed food (bread). The study will focus on the bioavailability of
      three principle carotenoids found in foods, alpha-carotene, beta-carotene and lycopene.
      Carrot and tomato are used as the sources of carotenoids.

      HYPOTHESIS Carotenoid bioavailability is influenced by the food matrix in which they are
      contained.

      OBJECTIVES

        1. To compare the acute-phase bioavailability (systemic and gut absorption) of targeted
           carotenoids (alpha-carotene, beta-carotene and lycopene) when they are incorporated into
           the different processed food matrices (bread and mayonnaise)

        2. Study how mayonnaise affects the acute bioavailability of carotenoids incorporated into
           a processed food.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Change in Carotenoid concentrations in plasma and in chylomicron-rich fraction
time frame: At baseline, at every hour for up to 8 hours postprandial and at 24hours after test meal
description: Carotenoids in plasma and in the chylomicron-rich fraction will be measured using reverse-phase HPLC
measure: Change in carotenoid concentration in urine
time frame: at baseline and at every hour for up to 8 hours post-prandial and at 24hours after test meal
description: Carotenoids in urine will be measured using reverse-phase HPLC
measure: Measurement of plasma retinol and retinyl ester concentrations
time frame: at baseline and at every hour for up to 8 hours post-prandial and at 24 hours after the test meal
description: Plasma retinol and retinyl ester concentrations will be measured using reverse-phase HPLC
measure: Plasma cholesterol concentrations
time frame: At baseline and at every hour for up to 8 hours post-prandial and at 24hours after the test meal
description: Plasma cholesterol concentrations will be measured using reverse-phase HPLC
measure: Satiety and palatability of test meals
time frame: immediately before and after consumption of test meals
description: Measured using 100mm continuous-line visual analogue scales anchored at each end with opposing answers to satiety and palatability related questions
arm group label: Plain bread with plain mayonnaise
arm group type: Experimental
description: Control meal. The bread and mayonnaise in this meal does not have vegetable powders incorporated into them, hence this meal does not contain carotenoids
arm group label: Vegetable bread only
arm group type: Experimental
description: A vegetable powder (carrot and tomato) containing bread portion will be served alone. The amount of vegetable powder in the bread will be standardised to contain a known amount of carotenoids
arm group label: Vegetable bread with plain mayonnaise
arm group type: Experimental
description: A vegetable powder (carrot and tomato) containing bread portion will be served with plain mayonnaise. The amount of vegetable powder in the bread will be standardised to contain a known amount of carotenoids.
arm group label: Plain bread with vegetable mayonnaise
arm group type: Experimental
description: Plain bread will be served with a vegetable powder (carrot and tomato) containing mayonnaise. The amount of vegetable powder in the mayonnaise will be standardised to contain a known amount of carotenoids.
intervention type: Dietary Supplement
intervention name: Control
description: The bread and mayonnaise in this meal does not have vegetable powders incorporated into them. Hence this meal does not contain carotenoids.
arm group label: Plain bread with plain mayonnaise
other name: plain bread with plain mayonnaise
intervention type: Dietary Supplement
intervention name: Vegetable bread only
description: A vegetable powder (carrot and tomato) containing bread portion will be served alone. The amount of vegetable powder in the bread portion will be standardised to contain a known amount of carotenoids.
arm group label: Vegetable bread only
intervention type: Dietary Supplement
intervention name: Plain bread with vegetable mayonnaise
description: Plain bread will be served with a vegetable powder (carrot and tomato) containing mayonnaise. The amount of vegetable powder in the mayonnaise will be standardised to contain a known amount of carotenoids.
arm group label: Plain bread with vegetable mayonnaise
intervention type: Dietary Supplement
intervention name: Vegetable bread with plain mayonnaise
description: A vegetable powder (Carrot and tomato) containing bread portion will be served with plain mayonnaise. The amount of vegetable powder in the bread portion will be standardised to contain a known amount of carotenoids
arm group label: Vegetable bread with plain mayonnaise
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Viren Ranawana, Msc, PhD
role: Principal Investigator
affiliation: Rowett Institute of Nutrition & Health, University of Aberdeen, Greenburn Road, Bucksburn, Aberdeen,, United Kingdom AB21 9SB
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
sharing ipd: No