Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-02-26 @ 6:28 AM
Study NCT ID:
NCT01403233
Status:
COMPLETED
Last Update Posted:
2012-06-14
First Post:
2011-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioavailability of Two Doses of cogniVida™ With One Dose of Rebaudioside A in Healthy Male Subjects
Sponsor:
DSM Nutritional Products, Inc.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
StevReb-PK
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: