<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/NCT02210507</url>
  </required_header>
  <id_info>
    <org_study_id>FL93</org_study_id>
    <nct_id>NCT02210507</nct_id>
  </id_info>
  <brief_title>Beta-carotene Absorption and Bioconversion to Vitamin A From Biofortified Cassava Gari</brief_title>
  <official_title>Beta-carotene Absorption and Bioconversion to Vitamin A in a Biofortified Cassava Gari Meal and a White Cassava Gari Meal With Added Red Palm Oil</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>USDA, Western Human Nutrition Research Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>HarvestPlus</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>USDA, Western Human Nutrition Research Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of the research study is to determine the absorption, metabolism, and bioconversion&#xD;
      of carotenoids such as beta-carotene to vitamin A from gari made with biofortified cassava&#xD;
      compared to a mixture of red palm oil and gari made from typical white cassava.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Vitamin A deficiency (VAD) is a major public health problem in most of the developing world,&#xD;
      especially Southern Asia and Sub-Saharan Africa. The primary issue in vitamin A deficient&#xD;
      populations is the low vitamin A content of the diet. Beta-carotene is the most abundant&#xD;
      provitamin A carotenoid in nature and in human tissues. Increasing the concentrations of&#xD;
      bioavailable vitamin A-forming carotenoids in staple foods by selective breeding is a good&#xD;
      strategy for improving vitamin A status. Cassava, bred to contain high amounts of vitamin&#xD;
      A-forming carotenoids is one such food, since it is a staple crop in Africa and parts of&#xD;
      South America. A popular cassava product Africa is gari, which is fermented, dewatered,&#xD;
      milled, and roasted so that it can be used for porridges and in baking. However, the effect&#xD;
      of feeding biofortified gari meals on carotenoid and vitamin A concentrations in the body is&#xD;
      not known. A common practice is to add red palm oil to typical white cassava gari. Red palm&#xD;
      oil is a very rich source of alpha-carotene and beta-carotene, in highly bioavailable forms.&#xD;
      Unfortunately, little is known of the bioconversion of red palm oil cassava mixture&#xD;
      carotenoids to vitamin A.&#xD;
&#xD;
      The primary purpose of this study is to determine the effect of consuming gari that is made&#xD;
      from biofortified cassava on carotenoid and vitamin A concentrations. The investigators will&#xD;
      compare carotenoid and vitamin A concentrations in individuals fed biofortified gari to the&#xD;
      same individuals fed gari made from ordinary cassava. The investigators hypothesis is that&#xD;
      the biofortified gari will increase carotenoid and vitamin A concentrations in&#xD;
      triacylglycerol-rich plasma (TRL). The secondary purpose of this study is to investigate the&#xD;
      effect of a meal of high carotenoid red palm oil added to typical white gari on carotenoids&#xD;
      and vitamin A. Adding red palm oil to white gari should be an effective method for increasing&#xD;
      carotenoids and vitamin A status in the gari meal, and thus humans. The investigators will&#xD;
      match the amount of retinol equivalents in the biofortified cassava gari and red palm&#xD;
      oil-containing white cassava gari. This will let us compare their effectiveness at increasing&#xD;
      carotenoid and vitamin A concentrations in the TRL plasma fraction after consumption. This&#xD;
      will allow us to compare their bioavailability and bioconversion efficiencies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in vitamin A in triacylglycerol-rich lipoprotein (TRL) fraction of plasma</measure>
    <time_frame>2, 3.5, 5, 7.25, and 9.5 hours after a meal</time_frame>
    <description>Vitamin A is measured by standard methods involving ultracentrifugation (to concentrate the TRL fraction) followed by reversed-phase high pressure liquid chromatography (HPLC) using electrochemical detection.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in carotenoids in triacylglycerol-rich lipoprotein (TRL) fraction of plasma</measure>
    <time_frame>2, 3.5, 5, 7.25, and 9.5 hours after a meal</time_frame>
    <description>Carotenoids will be measured by standard methods involving ultracentrifugation (to concentrate the TRL fraction) followed by reversed-phase HPLC using electrochemical detection.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Vitamin A Deficiency</condition>
  <arm_group>
    <arm_group_label>White cassava gari</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single meal containing 400 gm of garified non-biofortified (white) cassava with retinyl palmitate reference dose.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>White cassava gari + red palm oil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single meal containing 400 gm of garified non-biofortified (white) cassava with red palm oil.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Biofortified cassava gari</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single meal containing 400 gm of garified biofortified cassava.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Biofortified cassava gari</intervention_name>
    <description>Cassava, bred to contain high amounts of vitamin A-forming carotenoids (primarily beta-carotene and its cis-derivatives).</description>
    <arm_group_label>Biofortified cassava gari</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>White cassava gari</intervention_name>
    <description>Non-biofortified (white) cassava and a retinyl palmitate reference dose.</description>
    <arm_group_label>White cassava gari</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>White cassava gari + red palm oil</intervention_name>
    <description>Non-biofortified (white) cassava gari containing red palm oil.</description>
    <arm_group_label>White cassava gari + red palm oil</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy&#xD;
&#xD;
          -  non-pregnant, non-lactating&#xD;
&#xD;
          -  premenopausal women&#xD;
&#xD;
          -  non-smoking&#xD;
&#xD;
          -  body mass index between 18 and 35&#xD;
&#xD;
          -  total cholesterol concentrations between 90 and 225 mg/dL&#xD;
&#xD;
          -  blood pressure under 140/90 mm Hg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  anemia, Hemoglobin less than 11.5 g/dL&#xD;
&#xD;
          -  medications such as gemfibrozil, niacin, lovastatin, simvastatin, ezetimibe)&#xD;
&#xD;
          -  medications that affect retinoid or carotenoid metabolism (Accutane)&#xD;
&#xD;
          -  medications that impair fat absorption (Xenical, orlistat)&#xD;
&#xD;
          -  dietary supplements containing vitamin A&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Betty J Burri, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>USDA, ARS, Western Human Nutrition Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>USDA, ARS, Western Human Nutrition Research Center</name>
      <address>
        <city>Davis</city>
        <state>California</state>
        <zip>95616</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.ars.usda.gov/Main/docs.htm?docid=11240</url>
    <description>USDA, ARS, WHNRC</description>
  </link>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>January 9, 2015</last_update_submitted>
  <last_update_submitted_qc>January 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 12, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>vitamin A</keyword>
  <keyword>retinol</keyword>
  <keyword>carotenoids</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Night Blindness</mesh_term>
    <mesh_term>Vitamin A Deficiency</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/NCT02210507
org study id: FL93
nct id: NCT02210507
lead sponsor: 
collaborator: 
has dmc: No
The goal of the research study is to determine the absorption, metabolism, and bioconversion
      of carotenoids such as beta-carotene to vitamin A from gari made with biofortified cassava
      compared to a mixture of red palm oil and gari made from typical white cassava.
Vitamin A deficiency (VAD) is a major public health problem in most of the developing world,
      especially Southern Asia and Sub-Saharan Africa. The primary issue in vitamin A deficient
      populations is the low vitamin A content of the diet. Beta-carotene is the most abundant
      provitamin A carotenoid in nature and in human tissues. Increasing the concentrations of
      bioavailable vitamin A-forming carotenoids in staple foods by selective breeding is a good
      strategy for improving vitamin A status. Cassava, bred to contain high amounts of vitamin
      A-forming carotenoids is one such food, since it is a staple crop in Africa and parts of
      South America. A popular cassava product Africa is gari, which is fermented, dewatered,
      milled, and roasted so that it can be used for porridges and in baking. However, the effect
      of feeding biofortified gari meals on carotenoid and vitamin A concentrations in the body is
      not known. A common practice is to add red palm oil to typical white cassava gari. Red palm
      oil is a very rich source of alpha-carotene and beta-carotene, in highly bioavailable forms.
      Unfortunately, little is known of the bioconversion of red palm oil cassava mixture
      carotenoids to vitamin A.

      The primary purpose of this study is to determine the effect of consuming gari that is made
      from biofortified cassava on carotenoid and vitamin A concentrations. The investigators will
      compare carotenoid and vitamin A concentrations in individuals fed biofortified gari to the
      same individuals fed gari made from ordinary cassava. The investigators hypothesis is that
      the biofortified gari will increase carotenoid and vitamin A concentrations in
      triacylglycerol-rich plasma (TRL). The secondary purpose of this study is to investigate the
      effect of a meal of high carotenoid red palm oil added to typical white gari on carotenoids
      and vitamin A. Adding red palm oil to white gari should be an effective method for increasing
      carotenoids and vitamin A status in the gari meal, and thus humans. The investigators will
      match the amount of retinol equivalents in the biofortified cassava gari and red palm
      oil-containing white cassava gari. This will let us compare their effectiveness at increasing
      carotenoid and vitamin A concentrations in the TRL plasma fraction after consumption. This
      will allow us to compare their bioavailability and bioconversion efficiencies.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Change in vitamin A in triacylglycerol-rich lipoprotein (TRL) fraction of plasma
time frame: 2, 3.5, 5, 7.25, and 9.5 hours after a meal
description: Vitamin A is measured by standard methods involving ultracentrifugation (to concentrate the TRL fraction) followed by reversed-phase high pressure liquid chromatography (HPLC) using electrochemical detection.
measure: Change in carotenoids in triacylglycerol-rich lipoprotein (TRL) fraction of plasma
time frame: 2, 3.5, 5, 7.25, and 9.5 hours after a meal
description: Carotenoids will be measured by standard methods involving ultracentrifugation (to concentrate the TRL fraction) followed by reversed-phase HPLC using electrochemical detection.
arm group label: White cassava gari
arm group type: Experimental
description: A single meal containing 400 gm of garified non-biofortified (white) cassava with retinyl palmitate reference dose.
arm group label: White cassava gari + red palm oil
arm group type: Experimental
description: A single meal containing 400 gm of garified non-biofortified (white) cassava with red palm oil.
arm group label: Biofortified cassava gari
arm group type: Experimental
description: A single meal containing 400 gm of garified biofortified cassava.
intervention type: Other
intervention name: Biofortified cassava gari
description: Cassava, bred to contain high amounts of vitamin A-forming carotenoids (primarily beta-carotene and its cis-derivatives).
arm group label: Biofortified cassava gari
intervention type: Other
intervention name: White cassava gari
description: Non-biofortified (white) cassava and a retinyl palmitate reference dose.
arm group label: White cassava gari
intervention type: Other
intervention name: White cassava gari + red palm oil
description: Non-biofortified (white) cassava gari containing red palm oil.
arm group label: White cassava gari + red palm oil
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Betty J Burri, PhD
role: Principal Investigator
affiliation: USDA, ARS, Western Human Nutrition Research Center
facility: 
country: United States
url: http://www.ars.usda.gov/Main/docs.htm?docid=11240
description: USDA, ARS, WHNRC
responsible party type: Sponsor
mesh term: Night Blindness
mesh term: Vitamin A Deficiency