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The purpose of the study is to examine the bioavailability of cogniVida™ in 10 healthy male subjects after consumption of two different doses of cogniVida™ (50 mg and 100 mg) and to compare the plasma values with values obtained in subjects receiving rebaudioside A (303.68 mg). In addition, also safety and tolerability parameters 24 hours after ingestion of the study compounds will be determined.
cogniVida™ is considered a dietary supplement, and therefore it is not an approved drug by the Food and Drug Administration (FDA). It is regulated like a food. The U.S. Food and Drug Administration does not strictly regulate herbs and dietary supplements. The investigators do not claim that this supplement is meant to treat any ailment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cogniVida™ 50 mg/day | Experimental |
| |
| cogniVida™ 100 mg/day | Experimental |
| |
| Rebaudioside-A 303.7 mg/day | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cogniVida 50mg/day | Dietary Supplement | 2 capsules 25 mg (total 50 mg) cogniVida™ once a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Area under the Curve (AUC) (0-72 hours) being produced after cogniVida™ (50 and 100 mg) and rebaudioside A (303.68 mg) consumption | Blood sampling timepoints: cogniVida: 0 min, 15min, 30min, 45min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 48, and 72h after dosing. RebA: 0 min, 30min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36, 48, and 72h after dosing | 0 - 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to plasma peak (Tmax) being produced after cogniVida™ (50 and 100 mg) and rebaudioside A (303.68 mg) consumption | Blood sampling timepoints: cogniVida: 0 min, 15min, 30min, 45min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 48, and 72h after dosing. RebA: 0 min, 30min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36, 48, and 72h after dosing | 0 - 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dale Wilson, 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 |
|---|---|
| C025474 | rebaudioside A |
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| cogniVida100mg/day | Dietary Supplement | 4 capsules 25 mg (total 100 mg) cogniVida™ once a day |
|
| Rebaudioside-A 303.7mg/day | Dietary Supplement | 4 capsules 75.92 mg (total 303.68 mg) rebaudioside A once a day |
|
| Plasma Peak Concentration (Cmax) being produced after cogniVida™ (50 and 100 mg) and rebaudioside A (303.68 mg) consumption | Blood sampling timepoints: cogniVida: 0 min, 15min, 30min, 45min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 48, and 72h after dosing. RebA: 0 min, 30min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36, 48, and 72h after dosing | 0 - 72 hours |
| Time to reach half of peak concentration in plasma T1/2 being produced after cogniVida™ (50 and 100 mg) and rebaudioside A (303.68 mg) consumption | Blood sampling timepoints: cogniVida: 0 min, 15min, 30min, 45min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 48, and 72h after dosing. RebA: 0 min, 30min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36, 48, and 72h after dosing | 0 - 72 hours |
| Vital signs | Vital signs as safety parameters being measured 24 h after each supplementation. | 24 hours after each supplementation |
| White blood cell (WBC) count (Routine Haematology) | White blood cells will be counted as a routine haematology parameter to assess safety 24 h after each supplementation. | 24 hours after each supplementation |
| Hemoglobin (Routine Haematology) | Hemoglobin will be measured as a routine haematology parameter to assess safety 24 h after each supplementation. | 24 hours after each supplementation |
| Blood urea nitrogen (BUN) (Clinical Chemistry) | Blood urea nitrogen will be measured as a routine clinical chemistry parameter to assess safety 24 h after each supplementation. | 24 hours after each supplementation |
| Cystatin-C (Clinical Chemistry) | Cystatin-C will be measured as a routine clinical chemistry parameter to assess safety 24 h after each supplementation. | 24 hours after each supplementation |