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NCT03020680 · ClinicalTrials.gov registry record · Phase 1
Bioavailability of Ubiquinone and Ubiquinol in Older Adults
A Phase 1 study, sponsored by Tufts University.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT03020680: Completed Phase 1 study, sponsored by Tufts University.
NCT03020680 is a Phase 1 study that has completed, run by Tufts University. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03020680, a Phase 1 study, has completed, sponsored by Tufts University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study 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.
Primary Outcome
Concentration change of ubiquinol and ubiquinone in peripheral blood mononuclear cells before and after the 2-week supplementation of coenzyme Q10
Interventions
- DIETARY_SUPPLEMENT Coenzyme Q10
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2016-04-01 |
| Est. Completion | 2018-05-17 |
| Phase | Phase 1 |
What the finished NCT03020680 record still lists
NCT03020680 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which Coenzyme Q10 is the first listed.
NCT03020680 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03020680 about?
NCT03020680 is a clinical study titled "Bioavailability of Ubiquinone and Ubiquinol 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 ...
What is the current status of trial NCT03020680?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2016-04-01. Estimated completion is 2018-05-17.
What interventions are being tested in trial NCT03020680?
The interventions under investigation include: Coenzyme Q10 (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03020680?
This trial is sponsored by Tufts University, which has 163 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03020680's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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