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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
2 capsules 25 mg (total 50 mg) cogniVida™ once a day
4 capsules 25 mg (total 100 mg) cogniVida™ once a day
4 capsules 75.92 mg (total 303.68 mg) rebaudioside A once a day
KGK Synergize Inc
London, Ontario, Canada
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
Time frame: 0 - 72 hours
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
Time frame: 0 - 72 hours
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
Time frame: 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
Time frame: 0 - 72 hours
Vital signs
Vital signs as safety parameters being measured 24 h after each supplementation.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 hours after each supplementation
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