Assessing Two Coenzyme Q10 Products in Men and Women (NCT07530250) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Assessing Two Coenzyme Q10 Products in Men and Women
United States24 participantsStarted 2026-04
Plain-language summary
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.
Who can participate
Age range21 Years â 65 Years
SexALL
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Inclusion criteria
â. Male or female, between 21 and 65 y of age.
â. Individual has a BMI of 18.5 to 34.9 kg/m2.
â. Individual has a score âĽ7 on the Vein Access Scale.
â. Individual is willing to discontinue any dietary supplement use for two weeks prior to visit 2 and throughout the end of the testing period.
â. Individual is judged by the Investigator to be in generally good health on the basis of medical history and screening/baseline measurements.
â. Individual understands the study procedures, including maintaining usual physical activity pattern and refraining from vigorous physical activity for 24 h prior to each clinic visit requiring a blood draw. Signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
Exclusion criteria
â. 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).
What they're measuring
1
Total area under the curve (AUC) for plasma CoQ10
Timeframe: 7 to 14 days between conditions
Trial details
NCT IDNCT07530250
SponsorMidwest Center for Metabolic and Cardiovascular Research
. 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.
â. Individual has had any major trauma or surgical event within 12 weeks prior to screening/baseline (visit 1).
â. Individual has a history or presence of cancer in the prior two years, except for non-melanoma skin cancer.
â. Individual has uncontrolled hypertension (systolic blood pressure âĽ160 mm Hg and/or diastolic blood pressure âĽ100 mm Hg) at screening/baseline (visit 1).
â. Individual has a laboratory test result of clinical significance at screening/baseline (visit 1) based on the judgment of the Principal Investigator or qualified designee.
â. Individual has signs or symptoms of an active infection of clinical significance (e.g., urinary tract or respiratory) within five days prior to any test visit. If an infection occurs during the study period, test visits should be rescheduled until all signs and symptoms have been resolved for at least five days and, if antibiotics were prescribed, antibiotic therapy has been completed at least 7 days prior to the test visit.
â. Individual has unstable use (defined as initiation or change in dose, agent, or regimen) of statin therapy within 3 months of visit 1.