Pharmacokinetics of Different CoQ10 Formulations

Factors Group of Nutritional Companies

Status: Completed

Conditions: Coenzyme Q10 Pharmacokinetics

Treatments: Dietary Supplement: CoQ10

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06151171

2022-02-005

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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15 participants in 3 patient groups

Lipomicel Q10

Experimental group

Description:

Lipomicel Q10 (Natural Factors, Burnaby, BC, Canada). One soft gel capsule contains: 100 mg ubiquinone (oxidized form of CoQ10)

Treatment:

Dietary Supplement: CoQ10

CoQ10 NOW® Ubiquinol

Active Comparator group

Description:

CoQ10 (NOW® Ubiquinol, Bloomingdale, IL, USA). One soft gel capsule contains: 100 mg ubiquinol (reduced form of CoQ10).

Treatment:

Dietary Supplement: CoQ10

Qunol Ultra CoQ10

Active Comparator group

Description:

Qunol Ultra CoQ10 (Quten Research Institute, LLC, USA). One soft gel contains: 100 mg ubiquinone.

Treatment:

Dietary Supplement: CoQ10