Pharmacokinetics of Different CoQ10 Formulations

Study Overview
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Brief Summary
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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.

Official Title
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Pharmacokinetics of Different CoQ10 Formulations - a Randomized, Double-blind, Single-dose, Crossover Study on the Bioavailability

Conditions
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Coenzyme Q10 Pharmacokinetics

Intervention / Treatment
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* Dietary Supplement: CoQ10


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants are required to meet the following criteria to be eligible for enrollment: male or female aged 21-65 years or older Participants must complete an online health questionnaire on their medical history (pregnancy must be excluded) upon study enrolment. Voluntary, written, informed consent to participate in the study. Exclusion Criteria: Unstable medical condition; use of any acute medications during study period. Use of Coumadin Warfarin; use of supplements containing Coenzyme Q10, including the intake of any other supplements within 2 weeks of the beginning of the study (except for vitamin D and calcium). The use of any supplements except for vitamin D and calcium, are prohibited for the duration of the study. History of serious acute or chronic diseases such as gastrointestinal disorders, liver-, kidney-, cardiovascular, or hematological disease or diabetes; or other diseases; intolerances or food allergies such as gluten (in terms of the standardized meals). Using any form of nicotine or tobacco; participation in another investigational study

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lipomicel Q10<br>Lipomicel Q10 (Natural Factors, Burnaby, BC, Canada). One soft gel capsule contains: 100 mg ubiquinone (oxidized form of CoQ10) | Dietary Supplement: CoQ10<br>* 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.<br>|
| Active Comparator: CoQ10 NOW® Ubiquinol<br>CoQ10 (NOW® Ubiquinol, Bloomingdale, IL, USA). One soft gel capsule contains: 100 mg ubiquinol (reduced form of CoQ10). | Dietary Supplement: CoQ10<br>* 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.<br>|
| Active Comparator: Qunol Ultra CoQ10<br>Qunol Ultra CoQ10 (Quten Research Institute, LLC, USA). One soft gel contains: 100 mg ubiquinone. | Dietary Supplement: CoQ10<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bioavailability, CoQ10, Ubiquinol, delivery system, pharmacokinetics