Coenzyme Q10 Formulations for Pharmacokinetics Study

Overseen By Marc Moulin, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: 3i Solutions

Must not be taking: Cannabinoids, Tobacco, Alcohol, others

Disqualifiers: Pregnancy, Diabetes, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 71 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how well the body absorbs three different versions of Coenzyme Q10, a supplement that may aid energy and cellular health. Participants will take these CoQ10 formulations over 71 days, and researchers will measure blood levels of CoQ10 to determine which version absorbs best. This study suits healthy adults not on a special diet and without major health issues like diabetes or recent heart problems. As an unphased trial, it allows participants to contribute to understanding CoQ10 absorption, potentially benefiting future health supplements.

Do I need to stop taking my current medications to join the trial?

The trial requires participants to maintain their current lifestyle, including medications, as much as possible. However, if you are using medications, supplements, or consuming food/drinks that might impact the study's safety or effectiveness, you may need to stop or adjust them as assessed by the investigator.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Coenzyme Q10 (CoQ10) is generally safe for people. Studies have found it is well-tolerated in amounts up to 1200 mg per day. The doses in these products are much lower, between 50 mg and 100 mg, suggesting a low risk of side effects.

CoQ10 is a popular supplement known for its antioxidant benefits, which help protect cells from damage. Past research indicates no major safety concerns at typical doses, usually between 100 mg and 200 mg per day.

For VitaDry-Q10 and VitaSperse-Q10, studies show these versions are easily absorbed by the body, meaning they work well without causing harm. VitaSperse-Q10 is also safe for people who need to avoid certain foods like wheat or corn.

Overall, these CoQ10 products seem safe for most people. Previous trials and research support their safety at the doses being studied. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Coenzyme Q10 formulations—VitaDry-Q10, VitaSperse-Q10, and CoQ10—because they offer innovative delivery methods designed to potentially improve absorption. Unlike traditional CoQ10 supplements, which may have variable absorption rates, VitaDry-Q10 delivers a higher dose (100 mg) in a dry form that could enhance bioavailability. VitaSperse-Q10 introduces a unique dispersion technique with a 50 mg dose, aiming to ensure better absorption and quicker action in the body. These formulations could offer more consistent and efficient delivery of CoQ10, which is crucial for its role in supporting cellular energy production and antioxidant protection.

What evidence suggests that this trial's CoQ10 formulations could be effective?

Research shows that Coenzyme Q10 (CoQ10) plays a crucial role in cellular energy production. In this trial, participants will receive different formulations of CoQ10. Studies have found that the VitaDry and VitaSperse versions of CoQ10, tested in this trial, are absorbed by cells 6.0 and 5.5 times better, respectively, than regular CoQ10. These versions might help the body use CoQ10 more efficiently. Absorption of CoQ10 can vary significantly among individuals, but supplements can enhance absorption. Overall, CoQ10 is considered safe and essential for cell energy. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy adults interested in helping to compare how the body absorbs three different Coenzyme Q10 (CoQ10) formulations. Participants should be willing to have their blood levels of CoQ10 measured over a 71-day period.

Inclusion Criteria

BMI between 18.5 to 29.9 Kg/m3, inclusive

Provided voluntary, written, informed consent to participate in the study

Healthy as determined by medical history and laboratory results as assessed by the Qualified Investigator (QI)

Exclusion Criteria

Type I or Type II diabetes

Individuals who are pregnant, breast feeding, or planning to become pregnant during the study

Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of investigational products or comparator ingredients or inability to consume the standardized meals

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume three formulations of CoQ10 and are evaluated for CoQ10 levels in blood

71 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Coenzyme Q10
• VitaDry-Q10
• VitaSperse-Q10

Trial Overview

The study is testing three CoQ10 formulations: VitaDry-Q10, regular Coenzyme Q10, and VitaSperse-Q10. It aims to see which one gets into the bloodstream better by measuring the amount of drug in blood after taking each formulation.

How Is the Trial Designed?

Group I: VitaSperse-CoQ10 Experimental Treatment 1 Intervention

VitaSperse-CoQ10 contains 50 mg of CoQ10 per serving.

Group II: VitaDry-CoQ10 Experimental Treatment 1 Intervention

VitaDry CoQ10 contains 100 mg of CoQ10 per serving.

Group III: CoQ10 Experimental Treatment 1 Intervention

CoQ10 contains 50 mg of CoQ10 mg per serving.

Who Is Running the Clinical Trial?

3i Solutions

Lead Sponsor

KGK Science Inc.

Industry Sponsor

Trials

82

Recruited

6,400+

Najla Guthrie

KGK Science Inc.

Chief Executive Officer since 1997

Research career at the Centre for Human Nutrition, University of Western Ontario

Dr. Bibiane Zakaria

KGK Science Inc.

Chief Medical Officer since 2023

MD from an unspecified institution

Citations

1.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK531491/

Coenzyme Q10 - StatPearls - NCBI Bookshelf

Coenzyme Q10 (CoQ10), also known as ubiquinone, is a fat-soluble, vitamin-like molecule naturally present in every cellular membrane within our bodies.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04035525

Pharmacokinetic Study on Three Formulations of ...

The MaxSimil® + CoQ10 formulation is anticipated to provide the best vehicle to increase the bioavailability of CoQ10 with the lowest side effects for the ...

3.

mdpi.com

mdpi.com/2076-3921/9/5/386

Bioavailability of Coenzyme Q10: An Overview of the ...

The study therefore concluded that intestinal absorption of CoQ10 is highly variable among individuals, and is independent of the form of CoQ10 (ubiquinone/ ...

4.

link.springer.com

link.springer.com/article/10.1007/s10517-008-0270-8

Pharmacokinetics of coenzyme Q 10

The pharmacokinetics of coenzyme Q10 powder and solution of solubilized form was studied after their oral administration to rats (10 mg/kg).

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/16551570/

Coenzyme Q10: absorption, tissue uptake, metabolism and ...

CoQ10 absorption is slow, but enhanced by supplements. It has a 6h max time, 33h half-life, and is taken up by tissues. It has a good safety record.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/19096117/

Safety assessment of coenzyme Q10 (CoQ10)

Risk assessment for CoQ10 based on various clinical trial data indicates that the observed safety level (OSL) for CoQ10 is 1200 mg/day/person. Evidence from ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S2212429222008069

Pharmacokinetic profile and sub-chronic toxicity of ...

Pharmacokinetics data showed that CoQ10 concentrations in the plasma of rats fed with nanoparticles were higher than that of the free counterpart. CoQ10 ...

8.

go.drugbank.com

go.drugbank.com/articles/A31416

Coenzyme Q10: absorption, tissue uptake, metabolism and ...

Available data on the absorption, metabolism and pharmacokinetics of coenzyme Q10 (CoQ10) are reviewed in this paper. CoQ10 has a fundamental role in ...