A Phase 1 interventional study of cogniVida 50mg/day and cogniVida100mg/day in Healthy, sponsored by dsm-firmenich Switzerland AG. Completed at 1 site in Canada. Open to male participants aged 30 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-06-14.
Sponsored by dsm-firmenich Switzerland AG (part of dsm-firmenich) · Phase 1, Interventional, and Treatment
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.
dsm-firmenich Switzerland AG is the lead sponsor of 9 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Dietary Supplement: cogniVida 50mg/day
Dietary Supplement: cogniVida100mg/day
Dietary Supplement: Rebaudioside-A 303.7mg/day
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
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
The record gives a start of May 2011, a primary completion of Aug 2011 and a completion of Aug 2011. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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