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| Name | Class |
|---|---|
| Pharmavite LLC | INDUSTRY |
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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.
The study products will include 100 mg CoQ10 product designed for high absorption (administered as two 50 mg capsules) and 100 mg standard CoQ10 product (administered as two 50 mg capsules).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental - high absorption CoQ10 product | Experimental | 100 mg CoQ10 product designed for high absorption (administered as two 50 mg capsules) |
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| Active Comparator - standard CoQ10 product | Active Comparator | 100 mg standard CoQ10 product (administered as two 50 mg capsules) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| high absorption CoQ10 product | Dietary Supplement | 100 mg CoQ10 product designed for high absorption (administered as two 50 mg capsules) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 7 to 14 days between conditions |
| Measure | Description | Time Frame |
|---|---|---|
| Incremental area under the curve (iAUC) for plasma CoQ10 | Difference between conditions in the iAUC for plasma CoQ10 from 0 to 24 h where t = 0 is the time of study product ingestion | 7 to 14 days between conditions |
| Total area under the curve (AUC) for plasma CoQ10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caryn Adams, MPH | Contact | 6304696600 | cwolfe@mbclinicalresearch.com | |
| Sara Campbell, MPH | Contact | 6304696600 | scampbell@mbclinicalresearch.ocm |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biofortis Clinical Research | Recruiting | Addison | Illinois | 60101 | United States |
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| standard CoQ10 product | Dietary Supplement | 100 mg standard CoQ10 product (administered as two 50 mg capsules) |
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Difference between conditions in the total AUC for plasma CoQ10 from 0 to 24 h where t = 0 is the time of study product ingestion |
| 7 to 14 days between conditions |
| Unadjusted maximum concentration (Cmax) for plasma CoQ10 | Difference between conditions in the unadjusted Cmax for plasma CoQ10 from 0 to 24 h where t = 0 is the time of study product ingestion | 7 to 14 days between conditions |
| Baseline-adjusted maximum concentration (Cmax) for plasma CoQ10 | Difference between conditions in the baseline-adjusted Cmax for plasma CoQ10 from 0 to 24 h where t = 0 is the time of study product ingestion | 7 to 14 days between conditions |
| Time to maximum concentration (Tmax) for plasma CoQ10 | Difference between conditions in the Tmax for plasma CoQ10 from 0 to 24 h where t = 0 is the time of study product ingestion | 7 to 14 days between conditions |