NCT01403233

Bioavailability of Two Doses of cogniVida™ With One Dose of Rebaudioside A in Healthy Male Subjects

An Open-label, Sequential Supplementation Study Comparing the Bioavailability of Two Doses of cogniVida™ With One Dose of Rebaudioside A in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: dsm-firmenich Switzerland AG · Industry
• Sex: Male
• Age: 30 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	cogniVida 50mg/day	2 capsules 25 mg (total 50 mg) cogniVida™ once a day
DIETARY_SUPPLEMENT	cogniVida100mg/day	4 capsules 25 mg (total 100 mg) cogniVida™ once a day
DIETARY_SUPPLEMENT	Rebaudioside-A 303.7mg/day	4 capsules 75.92 mg (total 303.68 mg) rebaudioside A once a day

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2011-07-27
• Last updated: 2012-06-14

Locations

1 site across 1 country: Canada