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CompletedNCT06012669Updated Jun 11, 2025

Effects of Lactoferrin at Two Doses vs. Active Control on Markers of Immune Function

An interventional study of High dose Human Lactoferrin and Low dose Human Lactoferrin in Immune Health, sponsored by Midwest Center for Metabolic and Cardiovascular Research. Completed at 2 sites in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-11.

Sponsored by Midwest Center for Metabolic and Cardiovascular Research · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

Read the detailed description

Samples will be retained for possible analyses such as lactoferrin absorption, distribution, metabolism, and excretion (ADME) and gut microbiota.

02

Conditions studied

  • Immune Health
03

In context

Lead sponsor

Midwest Center for Metabolic and Cardiovascular Research is the lead sponsor of 28 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Individual is male or premenopausal female (approximately half males and half females), 18 to 45 years of age, inclusive.
  2. Individual has a BMI of ≥18.50 and \<30.00 kg/m2.
  3. Individual is judged to be in good health based on medical history and routine laboratory tests.
  4. Individual agrees to abstain from alcohol consumption and vigorous physical activity for at least 24 h prior to all test visits. According to the World Health Organization (WHO), vigorous physical activity may include running, fast cycling, fast swimming, or moving heavy objects.
  5. Individual understands the study procedures, and is willing to complete them, and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

Exclusion criteria

Exclusion Criteria:

  1. Individual is unwilling to avoid consumption of all dietary supplements (other than provided study products and multivitamin/mineral/calcium supplements) within 14 days of visit (day 0) and throughout the study period.
  2. Individual is a chronic user of nicotine products.
  3. Individual has a score \<7 on the Vein Access Scale.
  4. Individual has a positive test for illicit drugs on the urine drug screen.
  5. Individual has a clinically significant medical condition that, in the opinion of the Investigator, could interfere with the interpretation of the study results.
  6. Individual has an autoimmune disorder (e.g., type 1 diabetes, rheumatoid arthritis, Graves disease, multiple sclerosis, lupus, etc.).
  7. Individual has a gastrointestinal condition that would potentially interfere with absorption of the study product (e.g., inflammatory bowel disease, celiac disease, history of gastric bypass surgery, chronic gastritis).
  8. Individual has used medication or over-the-counter products (including herbal and dietary supplements) that, in the opinion of the investigator, could interfere with the absorption and metabolism of lactoferrin or affect inflammatory or immune function markers including, but not limited to, aspirin, anti-inflammatories, antacids, histamine 2 receptor antagonists, laxatives, stool softeners, and proton-pump inhibitors.
  9. Individual has had a weight change of ±4.5 kg (10 lbs.) in the previous 3 months.
  10. Individual has extreme dietary habits (e.g., Atkins, vegan, very low carbohydrate diet).
  11. Individual has history of bariatric surgery, is currently taking a weight loss drug, or is actively attempting to lose or gain body weight.
  12. Individual has an active infection or signs/symptoms of an infection. Test visits will be rescheduled to allow the subject to be symptom-free of any type of systemic infection for at least five days.
  13. Individual has recent use of antibiotics (within 7 days of visit 2, day 0) and throughout the study period. The test days will be rescheduled to allow the subject to wash out the antibiotic for at least 7 days.
  14. Individual has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg) at screening.
  15. Individual has a history of cancer in the prior 2 years, except non-melanoma skin cancer or carcinoma in situ of the cervix.
  16. Individual has an allergy or sensitivity to any components of the study products.
  17. Individual has an allergy or sensitivity to yeast.
  18. Individual is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.
  19. Individual has been exposed to any non-registered drug product within 30 days of the screening visit.
  20. Individual has a current or recent history (past 12 months of screening) or strong potential for illicit drug or excessive alcohol intake defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1.5 oz hard liquor).
  21. Individual has a condition the Investigator believes would interfere with his/her/their ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
66 participants (actual)

Study arms

  • Experimental
    Low Dose

    0.34 g Recombinant Human Lactoferrin

    Dietary Supplement: Low dose Human Lactoferrin

  • Experimental
    High Dose

    3.4 g Recombinant Human Lactoferrin

    Dietary Supplement: High dose Human Lactoferrin

  • Active comparator
    Active Control

    3.4 g Bovine Lactoferrin

    Dietary Supplement: Active Control Bovine Lactoferrin

Interventions

  • Dietary supplementHigh dose Human Lactoferrin

    Dietary Supplement and Food Ingredient

  • Dietary supplementLow dose Human Lactoferrin

    Dietary Supplement and Food Ingredient

  • Dietary supplementActive Control Bovine Lactoferrin

    Dietary Supplement and Food Ingredient

06

What researchers measure

Primary outcomes

  1. Antibodies

    Change from baseline in anti-lactoferrin antibodies

    Time frame: 0, 8 weeks

Secondary outcomes

  1. Markers of Immune Function

    Change from baseline in markers of Immune Function (such as biomarkers of inflammation)

    Time frame: 0, 4 weeks, 8 weeks, 12 weeks

  2. Markers of Immune Function

    Change from baseline in markers of Immune Function (such as T-cell responses to lactoferrin and related peptides)

    Time frame: 0, 8 weeks

07

Study locations

2 sites
  • Suncoast Research
    Miami, Florida 33135, United States
  • Health Awareness
    Port Saint Lucie, Florida 34952, United States
08

References and documents

Publications

  • 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. PubMed 39465888 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06012669
Lead sponsor
Midwest Center for Metabolic and Cardiovascular Research
Collaborators
Helaina Inc.
Responsible party
Sponsor
First posted
Aug 25, 2023
Start date
Sep 6, 2023
Primary completion
Dec 27, 2023
Completion
Dec 27, 2023
Last update
Jun 11, 2025

Study contacts

Kevin Maki, PhD
study director · MB Clinical Research & Consulting, LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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