Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-27 @ 6:20 AM
Study NCT ID:
NCT06232460
Status:
COMPLETED
Last Update Posted:
2025-05-09
First Post:
2024-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open Label, Dose-escalation Study, Assessing the Safety and Tolerability of a Collagen Peptide
Sponsor:
Rousselot BVBA
Organization:
Study Overview
Official Title:
An Open Label, Dose-escalation Study, Assessing the Safety and Tolerability of a Collagen Peptide
Status:
COMPLETED
Status Verified Date:
2024-08
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:
None
Brief Summary:
This study evaluates the safety and tolerability of three different doses (5 g, 10 g and 20 g) of a collagen powder in healthy adults over a 12-week period.
Detailed Description:
This study evaluates the safety and tolerability of three different doses (5 g, 10 g and 20 g) of a collagen powder, each for 4-weeks in healthy adults over a 12-week period by measuring occurrence of adverse events, safety blood panel, vital signs, occurrence of common gastrointestinal symptom's and the Gastrointestinal Symptom Rating Scale
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: