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| Name | Class |
|---|---|
| Isura | OTHER |
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The objective of this trial is to compare the bioavailability (AUC, Tmax, and Cmax) of different Coenzyme Q10 preparations in healthy adults. Pharmacokinetic parameters of orally ingested CoQ10 such as AUC, Cmax and Tmax, as well as the ratio of reduced CoQ10 levels to total CoQ10 plasma levels (using the AUC) after administration are compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lipomicel Q10 | Experimental | Lipomicel Q10 (Natural Factors, Burnaby, BC, Canada). One soft gel capsule contains: 100 mg ubiquinone (oxidized form of CoQ10) |
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| CoQ10 NOW® Ubiquinol | Active Comparator | CoQ10 (NOW® Ubiquinol, Bloomingdale, IL, USA). One soft gel capsule contains: 100 mg ubiquinol (reduced form of CoQ10). |
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| Qunol Ultra CoQ10 | Active Comparator | Qunol Ultra CoQ10 (Quten Research Institute, LLC, USA). One soft gel contains: 100 mg ubiquinone. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CoQ10 | Dietary Supplement | Participants will be randomly and blindly assigned to receive a single dose (200 mg) of one of the preparations (treatments). Fasting blood samples are taken at baseline (t=0) or pre-dose for CoQ10 baseline determination. Participants receive treatment at time zero with a glass of water (~ 125 mL), along with a standardized breakfast-provided immediately after the dose. Capsules are administered as a single oral dose, with a wash-out period of at least 3-4 weeks between the two Coenzyme Q10 test products. Capillary blood samples are collected at time points 0, 0.5, 1, 2, 3, 4,5, 6, 8, 10, 12, 24, 48- and 72-hours post-dose. A standardized lunch is provided after the 4hr blood sample, as well as a standardized dinner after the 8-h sample. Identical meals are served to all participants on each test day. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC: (the area under the concentration-time curve) to evaluate the absorption of orally ingested CoQ10 in different formulations and determine the ratio of reduced CoQ10 levels to total CoQ10 concentrations in healthy adults. | Blood concentrations of reduced and total CoQ10 are analyzed by ultra-performance liquid chromatography (UHPLC) coupled to a Thermo QExactive Orbitrap Mass Spectrometer. | 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours |
| Cmax: (maximum plasma concentration) To evaluate the peak concentrations of orally ingested CoQ10 in different formulations and determine the ratio of reduced CoQ10 levels to total CoQ10 concentrations in healthy adults. | 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours | |
| Tmax: (the time point of maximum plasma concentration) of orally ingested CoQ10 in different formulations and determine the ratio of reduced CoQ10 levels to total CoQ10 concentrations in healthy adults. | 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ISURA | Burnaby | British Columbia | V3N 4S9 | Canada |
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| ID | Term |
|---|---|
| C024989 | coenzyme Q10 |
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