CoQ10 Products for CoQ10 Blood Levels

Overseen By Sara Campbell, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Midwest Center for Metabolic and Cardiovascular Research

Must not be taking: Lipid-lowering, Anti-hypertensive, Hypoglycemic, others

Disqualifiers: Diabetes, Cardiovascular disorders, Cancer, others

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

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to compare the relative bioavailability of coenzyme Q10 (CoQ10) from acute administrations of a CoQ10 product designed for enhanced absorption versus a standard CoQ10 product in healthy men and women. Participants will be asked to come to the clinical on five different occasions, including a screening visit (visit 1, -7 days), two test 1 visits (visits 2 and 3, days 0 and 1), and two test 2 visits (visits 4 and 5, days 7 and 8). During the start of each test visit (visits 2 and 4), the participant will consume each study product with water and a standardized breakfast meal. Then, blood samples will be collected over a 10-hour period, and a standardized lunch, dinner, and snacks will be provided. The participant will return to the clinic the next morning for a blood draw 24 hours after the study product ingestion from the previous day. The same procedures will be repeated 7 to 14 days later with the other study product.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 21 and 65 years old.

Individual is judged by the Investigator to be in generally good health on the basis of medical history and screening/baseline measurements

Individual has a score of 7 or higher on the Vein Access Scale

Exclusion Criteria

Individual has been exposed to any non-registered drug product within 30 days prior to screening/baseline (visit 1)

Individual has a current or recent history or strong potential for illicit drug or excessive alcohol intake defined as >14 drinks per week

I have or had serious hormone, heart, lung, kidney, liver, or bile duct problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Test 1

Participants consume the first study product with a standardized meal, followed by blood sampling over 10 hours

2 days

2 visits (in-person)

Test 2

Participants consume the second study product with a standardized meal, followed by blood sampling over 10 hours

2 days

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• high absorption CoQ10 product
• standard CoQ10 product

How Is the Trial Designed?

Group I: Experimental - high absorption CoQ10 product Experimental Treatment 1 Intervention

100 mg CoQ10 product designed for high absorption (administered as two 50 mg capsules)

Group II: Active Comparator - standard CoQ10 product Active Control 1 Intervention

100 mg standard CoQ10 product (administered as two 50 mg capsules)

Who Is Running the Clinical Trial?

Midwest Center for Metabolic and Cardiovascular Research

Lead Sponsor

Trials

22

Recruited

880+

Pharmavite LLC

Industry Sponsor

Trials

12

Recruited

27,200+