Pharmacokinetic Study on Three Formulations of Coenzyme Q10 With Different Carriers

Summary

Coenzyme Q10 (CoQ10) is a vitamin-like substance produced in all living human cells and naturally occurring in dietary sources. In addition to being responsible for the synthesis of adenosine triphosphate (ATP), a major source of energy, CoQ10 plays an essential role in maintaining several biochemical pathways of the human body: i) it acts as a primary scavenger of free radicals, and ii) it protects membranes phospholipids from peroxidation and membranes proteins and mitochondrial DNA from oxidative damage. Despite the potential impact that it has shown in a wide array of health conditions, CoQ10 has been reported to have a poor bioavailability in humans with a slow and incomplete absorption from the small intestine. This has been attributed to its high molecular weight, strongly lipophilic nature and low aqueous solubility. To overcome the above limitations, various drug delivery systems such as liposomes, polymeric nanoparticles, polymeric micelles, solid lipid nanoparticles, nanostructured lipid carriers, self-emulsifying systems, nanoemulsions and solid and aqueous dispersions have been explored and developed to improve the solubility, the absorption and the bioavailability of CoQ10. Even though these different technologies and delivery systems were able to improve the absorption of CoQ10 and increase its bioavailability, the carriers used to deliver CoQ10 are based on synthetic products with no health benefits attributed to them. Aligned with its mission and vision to provide its clients with wellness products, Biodroga Neutraceuticals Inc developped a CoQ10 product using its patented MaxSimil technology that is based on omega-3 fatty acids (EPA and DHA) and this health product will be serving as the carrier for CoQ10. Therefore, the aim of this study is to perform a PK study using a powder product of CoQ10 and a rice bran oil + CoQ10 forms as comparators to the MaxSimil® + CoQ10 omega-3 supplement and compare their bioavailability and side effects. In this context, a randomized crossover design with a minimum of 7 days of washout between treatments will be used. The MaxSimil® + CoQ10 formulation is anticipated to provide the best vehicle to increase the bioavailability of CoQ10 with the lowest side effects for the participants.

Conditions

• Healthy

Interventions

DIETARY_SUPPLEMENT

MaxSimil® fish oil + CoQ10

The intervention is a randomized double blind cross over design testing the pharmacokinetics of 1) CoQ10 combined with MaxSimil fish oil as a carrier, 2) CoQ10 combined with rice bran oil as a carrier, and 3) CoQ10 as a powder form. Treatments are randomly assigned on days 1, 8 and 15 of the clinical study. Blood samples will be collected at time 0, 1, 2, 4, 5, 6, 8, 10, 12, 24 and 48 hours. Each participant will perform all three treatments, with a minimum of 7 days between treatments. A questionnaire will document the side effects felt by participants.

DIETARY_SUPPLEMENT

Rice bran oil + CoQ10

The intervention is a randomized double blind cross over design testing the pharmacokinetics of 1) CoQ10 combined with MaxSimil fish oil as a carrier, 2) CoQ10 combined with rice bran oil as a carrier, and 3) CoQ10 as a powder form. Treatments are randomly assigned on days 1, 8 and 15 of the clinical study. Blood samples will be collected at time 0, 1, 2, 4, 5, 6, 8, 10, 12, 24 and 48 hours. Each participant will perform all three treatments, with a minimum of 7 days between treatments. A questionnaire will document the side effects felt by participants.

DIETARY_SUPPLEMENT

CoQ10 as powder form

The intervention is a randomized double blind cross over design testing the pharmacokinetics of 1) CoQ10 combined with MaxSimil fish oil as a carrier, 2) CoQ10 combined with rice bran oil as a carrier, and 3) CoQ10 as a powder form. Treatments are randomly assigned on days 1, 8 and 15 of the clinical study. Blood samples will be collected at time 0, 1, 2, 4, 5, 6, 8, 10, 12, 24 and 48 hours. Each participant will perform all three treatments, with a minimum of 7 days between treatments. A questionnaire will document the side effects felt by participants.

Sponsors & Collaborators

• Mélanie Plourde

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-03-04

Primary Completion

2020-08-31

Completion

2020-08-31

Countries

• Canada

Study Locations