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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

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.

Condition or disease Intervention/treatment Phase
Absorption Dietary Supplement: Coenzyme Q10 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
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
Official Title: The Effect of Redox Status on Bioavailability of Ubiquinone and Ubiquinol in 10 Older Adults
Actual Study Start Date : April 1, 2016
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : May 17, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ubiquinol
It is the reduced form of coenzyme Q10
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

Active Comparator: ubiquinone
It is the oxidized form of coenzyme Q10
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   56 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03020680


Locations
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United States, Massachusetts
Oliver Chen
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University
Investigators
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Principal Investigator: Oliver Chen Tufts University
Publications:
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Responsible Party: Oliver Chen, Scientist I, Tufts University
ClinicalTrials.gov Identifier: NCT03020680    
Other Study ID Numbers: 2895
First Posted: January 13, 2017    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Ubiquinone
Coenzyme Q10
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Vitamins