Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT06012669
Status:
COMPLETED
Last Update Posted:
2025-06-11
First Post:
2023-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Lactoferrin at Two Doses vs. Active Control on Markers of Immune Function
Sponsor:
Midwest Center for Metabolic and Cardiovascular Research
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Controlled, Parallel-arm Trial to Assess the Effects of Lactoferrin at Two Doses vs. Active Control on Markers of Immune Function in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2025-06
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:
None
Brief Summary:
The purpose of this study is to evaluate the impact of 28-day supplementation with high-dose human recombinant lactoferrin, low-dose human recombinant lactoferrin, and an active control product formulated with bovine lactoferrin on indicators of immunity in healthy males and females.
Detailed Description:
Samples will be retained for possible analyses such as lactoferrin absorption, distribution, metabolism, and excretion (ADME) and gut microbiota.
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?: