Pharmacokinetics of Different CoQ10 Formulations

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

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.

Study Overview

• Status: Completed
• Conditions: Coenzyme Q10 Pharmacokinetics
• Intervention / Treatment: Dietary supplement: CoQ10

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Burnaby, British Columbia, Canada, V3N 4S9
      • ISURA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Factors Group of Nutritional Companies Inc.
• Collaborators: Isura

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: November 21, 2023
• First Submitted That Met QC Criteria: November 21, 2023
• First Posted (Actual): November 30, 2023

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: pharmacokinetics; bioavailability; CoQ10; Ubiquinol; delivery system
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins; Coenzyme Q10
• Other Study ID Numbers: 2022-02-005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No