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| Name | Class |
|---|---|
| Helaina Inc. | INDUSTRY |
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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.
Samples will be retained for possible analyses such as lactoferrin absorption, distribution, metabolism, and excretion (ADME) and gut microbiota.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose | Experimental | 0.34 g Recombinant Human Lactoferrin |
|
| High Dose | Experimental | 3.4 g Recombinant Human Lactoferrin |
|
| Active Control | Active Comparator | 3.4 g Bovine Lactoferrin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High dose Human Lactoferrin | Dietary Supplement | Dietary Supplement and Food Ingredient |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Antibodies | Change from baseline in anti-lactoferrin antibodies | 0, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Markers of Immune Function | Change from baseline in markers of Immune Function (such as biomarkers of inflammation) | 0, 4 weeks, 8 weeks, 12 weeks |
| Markers of Immune Function | Change from baseline in markers of Immune Function (such as T-cell responses to lactoferrin and related peptides) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Maki, PhD | MB Clinical Research & Consulting, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suncoast Research | Miami | Florida | 33135 | United States | ||
| Health Awareness |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39465888 | Result | Peterson RD, Guarneiri LL, Adams CG, Wilcox ML, Clark AJ, Rudemiller NP, Maki KC, Malinczak CA. A Randomized, Double-Blind, Controlled Trial to Assess the Effects of Lactoferrin at Two Doses vs. Active Control on Immunological and Safety Parameters in Healthy Adults. Int J Toxicol. 2025 Jan-Feb;44(1):12-28. doi: 10.1177/10915818241293723. Epub 2024 Oct 28. | |
| 42178844 |
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| Low dose Human Lactoferrin |
| Dietary Supplement |
Dietary Supplement and Food Ingredient |
|
| Active Control Bovine Lactoferrin | Dietary Supplement | Dietary Supplement and Food Ingredient |
|
| 0, 8 weeks |
| Port Saint Lucie |
| Florida |
| 34952 |
| United States |
| Peterson RD, van der Made J, Donovan SM, Wang M, Dilger RN, Kaplan N, Clark AJ. Effects of Human Lactoferrin (Effera(R)) at Two Doses Versus Bovine Lactoferrin on the Adult Gut Microbiome and Fecal Short-Chain Fatty Acids: a Randomized, Double-Blind Trial. J Diet Suppl. 2026;23(3):415-439. doi: 10.1080/19390211.2026.2673021. Epub 2026 May 24. |