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Bioavailability of Ubiquinone and Ubiquinol in Older Adults

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ClinicalTrials.gov Identifier: NCT03020680
Recruitment Status : Completed
First Posted : January 13, 2017
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Oliver Chen, Tufts University

Tracking Information
First Submitted Date  ICMJE August 30, 2016
First Posted Date  ICMJE January 13, 2017
Last Update Posted Date April 23, 2019
Actual Study Start Date  ICMJE April 1, 2016
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2019)
Concentration change of ubiquinol and ubiquinone in peripheral blood mononuclear cells [ Time Frame: before and after the 2-week supplementation of coenzyme Q10 ]
Concentration change of ubiquinol and ubiquinone in peripheral blood mononuclear cells before and after the 2-week supplementation of coenzyme Q10
Original Primary Outcome Measures  ICMJE
 (submitted: January 11, 2017)
Concentration change of ubiquinol and ubiquinone in peripheral blood mononuclear cells [ Time Frame: before and after the 2-week supplementation of coenzyme Q10 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2019)
Concentration change of ubiquinol and ubiquinone in plasma [ Time Frame: before and after the 2-week supplementation of coenzyme Q10 ]
Concentration change of ubiquinol and ubiquinone in plasma before and after the 2-week supplementation of coenzyme Q10
Original Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2017)
Concentration change of ubiquinol and ubiquinone in plasma [ Time Frame: before and after the 2-week supplementation of coenzyme Q10 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioavailability of Ubiquinone and Ubiquinol in Older Adults
Official Title  ICMJE The Effect of Redox Status on Bioavailability of Ubiquinone and Ubiquinol in 10 Older Adults
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE Absorption
Intervention  ICMJE Dietary Supplement: Coenzyme Q10
To examine whether 200 mg/d ubiquinol for 14 days increase coenzyme Q10 status by a larger degree than 200 mg/d ubiquinone
Study Arms  ICMJE
  • Experimental: ubiquinol
    It is the reduced form of coenzyme Q10
    Intervention: Dietary Supplement: Coenzyme Q10
  • Active Comparator: ubiquinone
    It is the oxidized form of coenzyme Q10
    Intervention: Dietary Supplement: Coenzyme Q10
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 19, 2019)
12
Original Estimated Enrollment  ICMJE
 (submitted: January 11, 2017)
10
Actual Study Completion Date  ICMJE May 17, 2018
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males
  • Age: >55 and <76 y
  • BMI: ≥25 and <35 kg/m2
  • Willing to take the assigned supplement for 4 weeks
  • Willing to maintain dietary habit for 6 week
  • <1000 µmol/L Fe2+ plasma total antioxidant capacity determined by Ferric Reducing Antioxidant Power and <400 µmol/L total thiol content in plasma

Exclusion Criteria:

  • Regular use of any dietary supplements containing vitamins and minerals; however, subjects who are willing to refrain from the use of these supplements for 1 mo prior to their enrollment and throughout the entire study may be considered eligible; subjects will be excluded if they are taking physician prescribed vitamin and/or mineral supplements
  • Use of medications known to affect lipid metabolism
  • Gain or loss of ≥5% of body weight in the last 6 mo
  • Impaired gastrointestinal, renal, and endocrine functions, diseases, conditions or medications influencing gastrointestinal absorption
  • Unusual dietary pattern, including vegan/vegetarian
  • Active treatment for cancer of any type longer than 1 year.
  • Daily alcoholic intake of more than 14 drinks/week (168 oz. beer, 56 oz. wine, 14 oz. hard liquor)
  • Values of standard blood biochemistries are critically abnormal based on study physician's
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 56 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03020680
Other Study ID Numbers  ICMJE 2895
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Oliver Chen, Tufts University
Study Sponsor  ICMJE Tufts University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Oliver Chen Tufts University
PRS Account Tufts University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP