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| Name | Class |
|---|---|
| Healthy Directions, LLC | UNKNOWN |
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The primary objective of this study is to assess the blood levels of Coenzyme Q10 in healthy subjects when administered Omega Q Plus® Resveratrol for 28 days.The secondary objective of the study is to determine if statin use has an impact on the blood levels of Coenzyme Q10 when administered Omega Q Plus® Resveratrol for 28 days. The safety objectives will include assessment of safety evaluations as determined by:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Population | Active Comparator | Healthy Population with Omega Q Plus Resveratrol (with 50mg CoQ10) |
|
| Population taking Statins | Active Comparator | Population taking Statins with Omega Q Plus Resveratrol (with 50mg CoQ10) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega Q Plus Resveratrol (with 50mg CoQ10) | Dietary Supplement | Omega Q Plus Resveratrol (with 50mg CoQ10) |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the blood levels of Coenzyme Q10 in healthy subjects when administered Omega Q Plus® Resveratrol for 28 days. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in blood levels of Coenzyme Q10 at 28 days | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from,14 days prior to Baseline, in safety blood chemistry parameters (glucose, creatinine, AST, ALT, GGT, bilirubin) at 28 days | 42 days | |
| Change from,14 days prior to Baseline, in vital signs at 28 days | 42 days |
Inclusion Criteria:
Inclusion criteria for healthy adults
OR Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include: Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System). Double-barrier method. Non-hormonal intrauterine devices. Vasectomy of partner. Non-heterosexual lifestyle (same-sex relationship).
Inclusion criteria for adults on statin medications
OR Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include:Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System). Double-barrier method. Non-hormonal intrauterine devices. Vasectomy of partner.Non-heterosexual lifestyle (same-sex relationship)
Exclusion Criteria:
Exclusion criteria for healthy adults
Exclusion criteria for adults on statins
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| Name | Affiliation | Role |
|---|---|---|
| Tetyana Pelipyagina, MD | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Synergize Inc. | London | Ontario | N6A 5R8 | Canada |
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| ID | Term |
|---|---|
| D000077185 | Resveratrol |
| C024989 | coenzyme Q10 |
| ID | Term |
|---|---|
| D000081225 | Stilbestrols |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
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| Number of Participants with Adverse Events | 42 days |
| Change from,14 days prior to Baseline, in hematology parameters (CBC, electrolytes) to 28 days | 42 days |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D059808 | Polyphenols |
| D010636 | Phenols |