Completed

NCT Number: NCT06151171

Pharmacokinetics of Different CoQ10 Formulations

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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Key information

Conditions

Coenzyme Q10 Pharmacokinetics

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ISURA

Burnaby, British Columbia, V3N 4S9, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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.

Time frame: 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.
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.

Time frame: 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.

Time frame: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours

Sponsors and collaborators

Lead sponsor

Factors Group of Nutritional Companies Inc.

Industry

Collaborators

Isura

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Nov 30, 2023
Registry last updated: Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.