<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/NCT03020680</url>
  </required_header>
  <id_info>
    <org_study_id>2895</org_study_id>
    <nct_id>NCT03020680</nct_id>
  </id_info>
  <brief_title>Bioavailability of Ubiquinone and Ubiquinol in Older Adults</brief_title>
  <official_title>The Effect of Redox Status on Bioavailability of Ubiquinone and Ubiquinol in 10 Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tufts University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tufts University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Coenzyme Q10 (or CoQ10) is a marketed supplement in US even though it can be synthesized in&#xD;
      the body via complicated biochemical pathways. It exists in both reduced and oxidized states,&#xD;
      namely ubiquinol and ubiquinone, respectively. It is commonly present in all cell membranes.&#xD;
      The main function of CoQ10 is to participate in energy production. Further, the reduced form&#xD;
      of CoQ10, ubiquinol, is appreciated as an important lipophilic antioxidant to protect free&#xD;
      radical induced damages to DNA, lipid, and proteins. Given that older adults have increased&#xD;
      production of free radicals, suboptimal antioxidant defenses toward free radicals, and a&#xD;
      decreased capability to replenish utilized CoQ10, CoQ10 supplementation can be one of&#xD;
      feasible ways to increase CoQ10 status in order adults. Most supplements available for&#xD;
      consumers are in the oxidized form. While the ubiquinol form is also available, whether the&#xD;
      reduced form will be more effective to replenish CoQ10 status in older subjects remains to be&#xD;
      explored. Thus, investigators aimed to examine whether ubiquinol will be more effectively&#xD;
      absorbed in older adults with a low antioxidant defense status. To pursue this aim,&#xD;
      investigators will conduct a double blind, randomized, crossover design trail with 5 study&#xD;
      visits (1 screening visit and 4 study visits). Ten older men (&gt;55 y, BMI: 25-5 kg/m2) with a&#xD;
      compromised antioxidant defenses will be recruited and complete the trial. Eligible subjects&#xD;
      will be randomized to receive 200 mg/d ubiquinol or ubiquinone for 2 weeks with 2-week&#xD;
      washout between crossover. Ubiquinol and ubiquinone in plasma and immune cells in blood will&#xD;
      be assessed to reveal whether the reduced form, ubiquinol, is more absorbable than the&#xD;
      oxidized form, ubiquinone in older adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Coenzyme Q10 (or CoQ10) is a marketed supplement in US even though it can be synthesized in&#xD;
      the body via complicated biochemical pathways. It exists in both reduced and oxidized states,&#xD;
      namely ubiquinol and ubiquinone, respectively. It is commonly present in all cell membranes.&#xD;
      The main function of CoQ10 is to participate in energy production. Further, the reduced form&#xD;
      of CoQ10, ubiquinol, is appreciated as an important lipophilic antioxidant to protect free&#xD;
      radical induced damages to DNA, lipid, and proteins. Given that older adults have increased&#xD;
      production of free radicals, suboptimal antioxidant defenses toward free radicals, and a&#xD;
      decreased capability to replenish utilized CoQ10, CoQ10 supplementation can be one of&#xD;
      feasible ways to increase CoQ10 status in order adults. Most supplements available for&#xD;
      consumers are in the oxidized form. While the ubiquinol form is also available, whether the&#xD;
      reduced form will be more effective to replenish CoQ10 status in older subjects remains to be&#xD;
      explored. Thus, investigators aimed to examine whether ubiquinol will be more effectively&#xD;
      absorbed in older adults with a low antioxidant defense status. To pursue this aim,&#xD;
      investigators will conduct a double blind, randomized, crossover design trail with 5 study&#xD;
      visits (1 screening visit and 4 study visits). Ten older men (&gt;55 y, BMI: 25-5 kg/m2) with a&#xD;
      compromised antioxidant defenses will be recruited and complete the trial. Eligible subjects&#xD;
      will be randomized to receive 200 mg/d ubiquinol or ubiquinone for 2 weeks with 2-week&#xD;
      washout between crossover. Ubiquinol and ubiquinone in plasma and immune cells in blood will&#xD;
      be assessed to reveal whether the reduced form, ubiquinol, is more absorbable than the&#xD;
      oxidized form, ubiquinone in older male adults.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2016</start_date>
  <completion_date type="Actual">May 17, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</primary_completion_date>
  <phase>Phase 1</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>
    <intervention_model_description>two 14-day intervention phases with a 2-week washout between each phase. randomized to receive 200mg/day ubiquinol or 200mg/day ubiquinone</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Concentration change of ubiquinol and ubiquinone in peripheral blood mononuclear cells</measure>
    <time_frame>before and after the 2-week supplementation of coenzyme Q10</time_frame>
    <description>Concentration change of ubiquinol and ubiquinone in peripheral blood mononuclear cells before and after the 2-week supplementation of coenzyme Q10</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Concentration change of ubiquinol and ubiquinone in plasma</measure>
    <time_frame>before and after the 2-week supplementation of coenzyme Q10</time_frame>
    <description>Concentration change of ubiquinol and ubiquinone in plasma before and after the 2-week supplementation of coenzyme Q10</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Absorption</condition>
  <arm_group>
    <arm_group_label>ubiquinol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>It is the reduced form of coenzyme Q10</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ubiquinone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>It is the oxidized form of coenzyme Q10</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Coenzyme Q10</intervention_name>
    <description>To examine whether 200 mg/d ubiquinol for 14 days increase coenzyme Q10 status by a larger degree than 200 mg/d ubiquinone</description>
    <arm_group_label>ubiquinol</arm_group_label>
    <arm_group_label>ubiquinone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males&#xD;
&#xD;
          -  Age: &gt;55 and &lt;76 y&#xD;
&#xD;
          -  BMI: ≥25 and &lt;35 kg/m2&#xD;
&#xD;
          -  Willing to take the assigned supplement for 4 weeks&#xD;
&#xD;
          -  Willing to maintain dietary habit for 6 week&#xD;
&#xD;
          -  &lt;1000 µmol/L Fe2+ plasma total antioxidant capacity determined by Ferric Reducing&#xD;
             Antioxidant Power and &lt;400 µmol/L total thiol content in plasma&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Regular use of any dietary supplements containing vitamins and minerals; however,&#xD;
             subjects who are willing to refrain from the use of these supplements for 1 mo prior&#xD;
             to their enrollment and throughout the entire study may be considered eligible;&#xD;
             subjects will be excluded if they are taking physician prescribed vitamin and/or&#xD;
             mineral supplements&#xD;
&#xD;
          -  Use of medications known to affect lipid metabolism&#xD;
&#xD;
          -  Gain or loss of ≥5% of body weight in the last 6 mo&#xD;
&#xD;
          -  Impaired gastrointestinal, renal, and endocrine functions, diseases, conditions or&#xD;
             medications influencing gastrointestinal absorption&#xD;
&#xD;
          -  Unusual dietary pattern, including vegan/vegetarian&#xD;
&#xD;
          -  Active treatment for cancer of any type longer than 1 year.&#xD;
&#xD;
          -  Daily alcoholic intake of more than 14 drinks/week (168 oz. beer, 56 oz. wine, 14 oz.&#xD;
             hard liquor)&#xD;
&#xD;
          -  Values of standard blood biochemistries are critically abnormal based on study&#xD;
             physician's&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>56 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Oliver Chen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tufts University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oliver Chen</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Zhang Y , Liu J , Chen XQ , Oliver Chen CY . Ubiquinol is superior to ubiquinone to enhance Coenzyme Q10 status in older men. Food Funct. 2018 Nov 14;9(11):5653-5659. doi: 10.1039/c8fo00971f.</citation>
    <PMID>30302465</PMID>
  </reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>August 30, 2016</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>April 19, 2019</last_update_submitted>
  <last_update_submitted_qc>April 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tufts University</investigator_affiliation>
    <investigator_full_name>Oliver Chen</investigator_full_name>
    <investigator_title>Scientist I</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ubiquinone</mesh_term>
    <mesh_term>Coenzyme Q10</mesh_term>
  </intervention_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/NCT03020680
org study id: 2895
nct id: NCT03020680
lead sponsor: 
has dmc: No
Coenzyme Q10 (or CoQ10) is a marketed supplement in US even though it can be synthesized in
      the body via complicated biochemical pathways. It exists in both reduced and oxidized states,
      namely ubiquinol and ubiquinone, respectively. It is commonly present in all cell membranes.
      The main function of CoQ10 is to participate in energy production. Further, the reduced form
      of CoQ10, ubiquinol, is appreciated as an important lipophilic antioxidant to protect free
      radical induced damages to DNA, lipid, and proteins. Given that older adults have increased
      production of free radicals, suboptimal antioxidant defenses toward free radicals, and a
      decreased capability to replenish utilized CoQ10, CoQ10 supplementation can be one of
      feasible ways to increase CoQ10 status in order adults. Most supplements available for
      consumers are in the oxidized form. While the ubiquinol form is also available, whether the
      reduced form will be more effective to replenish CoQ10 status in older subjects remains to be
      explored. Thus, investigators aimed to examine whether ubiquinol will be more effectively
      absorbed in older adults with a low antioxidant defense status. To pursue this aim,
      investigators will conduct a double blind, randomized, crossover design trail with 5 study
      visits (1 screening visit and 4 study visits). Ten older men (>55 y, BMI: 25-5 kg/m2) with a
      compromised antioxidant defenses will be recruited and complete the trial. Eligible subjects
      will be randomized to receive 200 mg/d ubiquinol or ubiquinone for 2 weeks with 2-week
      washout between crossover. Ubiquinol and ubiquinone in plasma and immune cells in blood will
      be assessed to reveal whether the reduced form, ubiquinol, is more absorbable than the
      oxidized form, ubiquinone in older adults.
Coenzyme Q10 (or CoQ10) is a marketed supplement in US even though it can be synthesized in
      the body via complicated biochemical pathways. It exists in both reduced and oxidized states,
      namely ubiquinol and ubiquinone, respectively. It is commonly present in all cell membranes.
      The main function of CoQ10 is to participate in energy production. Further, the reduced form
      of CoQ10, ubiquinol, is appreciated as an important lipophilic antioxidant to protect free
      radical induced damages to DNA, lipid, and proteins. Given that older adults have increased
      production of free radicals, suboptimal antioxidant defenses toward free radicals, and a
      decreased capability to replenish utilized CoQ10, CoQ10 supplementation can be one of
      feasible ways to increase CoQ10 status in order adults. Most supplements available for
      consumers are in the oxidized form. While the ubiquinol form is also available, whether the
      reduced form will be more effective to replenish CoQ10 status in older subjects remains to be
      explored. Thus, investigators aimed to examine whether ubiquinol will be more effectively
      absorbed in older adults with a low antioxidant defense status. To pursue this aim,
      investigators will conduct a double blind, randomized, crossover design trail with 5 study
      visits (1 screening visit and 4 study visits). Ten older men (>55 y, BMI: 25-5 kg/m2) with a
      compromised antioxidant defenses will be recruited and complete the trial. Eligible subjects
      will be randomized to receive 200 mg/d ubiquinol or ubiquinone for 2 weeks with 2-week
      washout between crossover. Ubiquinol and ubiquinone in plasma and immune cells in blood will
      be assessed to reveal whether the reduced form, ubiquinol, is more absorbable than the
      oxidized form, ubiquinone in older male adults.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: two 14-day intervention phases with a 2-week washout between each phase. randomized to receive 200mg/day ubiquinol or 200mg/day ubiquinone
primary purpose: Other
masking: Double (Participant, Investigator)
measure: Concentration change of ubiquinol and ubiquinone in peripheral blood mononuclear cells
time frame: before and after the 2-week supplementation of coenzyme Q10
description: Concentration change of ubiquinol and ubiquinone in peripheral blood mononuclear cells before and after the 2-week supplementation of coenzyme Q10
measure: Concentration change of ubiquinol and ubiquinone in plasma
time frame: before and after the 2-week supplementation of coenzyme Q10
description: Concentration change of ubiquinol and ubiquinone in plasma before and after the 2-week supplementation of coenzyme Q10
arm group label: ubiquinol
arm group type: Experimental
description: It is the reduced form of coenzyme Q10
arm group label: ubiquinone
arm group type: Active Comparator
description: It is the oxidized form of coenzyme Q10
intervention type: Dietary Supplement
intervention name: Coenzyme Q10
description: To examine whether 200 mg/d ubiquinol for 14 days increase coenzyme Q10 status by a larger degree than 200 mg/d ubiquinone
arm group label: ubiquinol
arm group label: ubiquinone
criteria: 
gender: Male
minimum age: 56 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Oliver Chen
role: Principal Investigator
affiliation: Tufts University
facility: 
country: United States
citation: Zhang Y , Liu J , Chen XQ , Oliver Chen CY . Ubiquinol is superior to ubiquinone to enhance Coenzyme Q10 status in older men. Food Funct. 2018 Nov 14;9(11):5653-5659. doi: 10.1039/c8fo00971f.
PMID: 30302465
responsible party type: Principal Investigator
investigator affiliation: Tufts University
investigator full name: Oliver Chen
investigator title: Scientist I
mesh term: Ubiquinone
mesh term: Coenzyme Q10
sharing ipd: No