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NCT06428357 · ClinicalTrials.gov registry record · NA
Efficacy of Recombinant Bovine Lactoferrin (rbLf) in Iron Regulation
A NA study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 92
- Enrollment target
NCT06428357 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 92 participants.
The verdict
NCT06428357, a NA study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 92 participants
- Enrollment target
Study Summary
Overall Objective: To determine the efficacy of rbLf supplementation in a healthy adult population, specifically with regard to iron regulation (primary), gut health (secondary), and immune function (secondary). Purpose: The purpose of this study is to determine the effects of rbLf on iron regulation, exercise performance, gut health, and immune function as compared to cow's milk derived bLf. Participants: To account for an approximate \~10% dropout rate (and rounding up to ensure equal number of enrolled participants per group), n=25 per group for males (N=50) and n=30 per group for females (N=60) will be enrolled for a total sample size of N=110. Procedures: Participation in this study will include 6 in-person visits over 14 weeks. Anemia will be checked and excluded at the first visit using a single finger prick, followed by a 10-20 min exercise test on a treadmill to evaluate exercise capacity. On visit 2 participants will perform three 3-15 minute exercise tests on a treadmill with rest in between each test in order to determine exercise performance. A finger prick will be performed before and after each run to determine lactate levels. After visits 2 participants will be randomized to their respective supplement group recombinant Bovine Lactoferrin supplement (rbLf) (Male and Fame), a bovine-milk derived Lactoferrin supplement (Female), or a placebo (Male) once daily for 4 weeks. Blood samples will be obtained prior to and after each supplement phase to determine change in iron levels and red blood cell capacity. After a 2-week washout participants will return to complete the same testing outcomes and will receive the subsequent supplement. At visit 6 a final blood sample will be collected.
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Recombinant Bovine Lactoferrin
- DIETARY_SUPPLEMENT Bovine Milk-Derived Lactoferrin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2024-07-05 |
| Est. Completion | 2025-07-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06428357
The ClinicalTrials.gov registry entry for NCT06428357 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 92 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT06428357 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06428357 about?
NCT06428357 is a clinical study titled "Efficacy of Recombinant Bovine Lactoferrin (rbLf) in Iron Regulation". Overall Objective: To determine the efficacy of rbLf supplementation in a healthy adult population, specifically with regard to iron regulation (primary), gut health (secondary), and immune function (secondary). Purpose: The purpose of this study is to determine the effects of rbLf on iron regulatio...
What is the current status of trial NCT06428357?
This trial is currently completed. It is a NA study. The enrollment target is 92 participants. The study started on 2024-07-05. Estimated completion is 2025-07-07.
What interventions are being tested in trial NCT06428357?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Recombinant Bovine Lactoferrin (DIETARY_SUPPLEMENT), Bovine Milk-Derived Lactoferrin (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT06428357?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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