Pharmacokinetics of Different CoQ10 Formulations

NCT ID: NCT06151171

Last Updated: 2023-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2022-10-31

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.

Detailed Description

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Conditions

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Coenzyme Q10 Pharmacokinetics

Keywords

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bioavailability CoQ10 Ubiquinol delivery system pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Lipomicel Q10

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

Group Type EXPERIMENTAL

CoQ10

Intervention Type 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.

CoQ10 NOW® Ubiquinol

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

Group Type ACTIVE_COMPARATOR

CoQ10

Intervention Type 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.

Qunol Ultra CoQ10

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

Group Type ACTIVE_COMPARATOR

CoQ10

Intervention Type 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.

Interventions

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CoQ10

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.

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Isura

OTHER

Sponsor Role collaborator

Factors Group of Nutritional Companies Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ISURA

Burnaby, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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2022-02-005

Identifier Type: -

Identifier Source: org_study_id