Assessing Two Coenzyme Q10 Products in Men and Women

ConditionCoQ10 Blood Levels

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age21-65

SponsorMidwest Center for Metabolic and Cardiovascular Research

About 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male or female, between 21 and 65 y of age.

Individual has a BMI of 18.5 to 34.9 kg/m2.

Individual has a score ≥7 on the Vein Access Scale.

Individual is willing to discontinue any dietary supplement use for two weeks prior to visit 2 and throughout the end of the testing period.

Disqualifiers

Individual has any gastrointestinal condition that could potentially interfere with absorption of the study product (e.g., inflammatory bowel syndrome, celiac disease, history of gastric bypass surgery).

Individual has a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), cardiovascular (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, or stroke), pulmonary, renal, hepatic, or biliary disorders.

Individual has had any major trauma or surgical event within 12 weeks prior to screening/baseline (visit 1).

Individual has a history or presence of cancer in the prior two years, except for non-melanoma skin cancer.

Trial design

Design model

Crossover

Treatments tested in this trial

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

Treatment groups

24 Participants

are divided into 2 treatment groups

Group A: Experimental - high absorption CoQ10 productExperimental treatment 1 intervention

Group B: Active Comparator - standard CoQ10 productActive comparator 1 intervention

Trial outcomes

Primary outcomes

Net incremental area under the curve (niAUC) for plasma CoQ10

Difference between conditions in the niAUC for plasma CoQ10 from 0 to 24 h where t = 0 is the time of study product ingestion

Time frame