Bioavailability of Ubiquinone and Ubiquinol in Older Adults

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Massachusetts

Oliver Chen

Boston, Massachusetts, United States, 02111

Sponsors and Collaborators

Tufts University

Investigators

• Principal Investigator: Oliver Chen; Tufts University

More Information

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.

• Responsible Party: Oliver Chen, Scientist I, Tufts University
• ClinicalTrials.gov Identifier: NCT03020680
• Other Study ID Numbers: 2895
• First Posted: January 13, 2017
• 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:

Ubiquinone; Coenzyme Q10; Micronutrients; Physiological Effects of Drugs; Vitamins