Pharmacokinetics of Different CoQ10 Formulations

Not Applicable

Completed

• Conditions: Coenzyme Q10 Pharmacokinetics
• Interventions: Dietary Supplement: CoQ10

• Registration Number: NCT06151171
• Lead Sponsor: Factors Group of Nutritional Companies Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-01
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31
• Status Verified: 2023-11
• Study First Submitted: 2023-11-21
• Study First Submitted QC: 2023-11-21
• Last Update Submitted: 2023-11-29
• Study First Posted: 2023-11-30
• Last Update Posted: 2023-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Qunol Ultra CoQ10	CoQ10	Qunol Ultra CoQ10 (Quten Research Institute, LLC, USA). One soft gel contains: 100 mg ubiquinone.
CoQ10 NOW® Ubiquinol	CoQ10	CoQ10 (NOW® Ubiquinol, Bloomingdale, IL, USA). One soft gel capsule contains: 100 mg ubiquinol (reduced form of CoQ10).
Lipomicel Q10	CoQ10	Lipomicel Q10 (Natural Factors, Burnaby, BC, Canada). One soft gel capsule contains: 100 mg ubiquinone (oxidized form of CoQ10)

Primary Outcome Measures

Name	Time	Method
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
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.	0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours	Blood concentrations of reduced and total CoQ10 are analyzed by ultra-performance liquid chromatography (UHPLC) coupled to a Thermo QExactive Orbitrap Mass Spectrometer.
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

Trial Locations

Locations (1)

ISURA; 🇨🇦 Burnaby, British Columbia, Canada