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

NCT06012669 | Completed

• 1 other identifier: MB-2305
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

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.

Conditions

Immune Health

Outcome Measures

Primary Outcomes (1)

• Antibodies

  Change from baseline in anti-lactoferrin antibodies

  0, 8 weeks

Secondary Outcomes (2)

• Markers of Immune Function

  0, 4 weeks, 8 weeks, 12 weeks

• Markers of Immune Function

  0, 8 weeks

Study Arms (3)

Low Dose

EXPERIMENTAL

0.34 g Recombinant Human Lactoferrin

Dietary Supplement: Low dose Human Lactoferrin

High Dose

EXPERIMENTAL

3.4 g Recombinant Human Lactoferrin

Dietary Supplement: High dose Human Lactoferrin

Active Control

ACTIVE COMPARATOR

3.4 g Bovine Lactoferrin

Dietary Supplement: Active Control Bovine Lactoferrin

Interventions

High dose Human Lactoferrin DIETARY_SUPPLEMENT

Dietary Supplement and Food Ingredient

High Dose

Low dose Human Lactoferrin DIETARY_SUPPLEMENT

Dietary Supplement and Food Ingredient

Low Dose

Active Control Bovine Lactoferrin DIETARY_SUPPLEMENT

Dietary Supplement and Food Ingredient

Active Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Individual is male or premenopausal female (approximately half males and half females), 18 to 45 years of age, inclusive.
• Individual has a BMI of ≥18.50 and \<30.00 kg/m2.
• Individual is judged to be in good health based on medical history and routine laboratory tests.
• 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.
• 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.

You may not qualify if:

• 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.
• Individual is a chronic user of nicotine products.
• Individual has a score \<7 on the Vein Access Scale.
• Individual has a positive test for illicit drugs on the urine drug screen.
• Individual has a clinically significant medical condition that, in the opinion of the Investigator, could interfere with the interpretation of the study results.
• Individual has an autoimmune disorder (e.g., type 1 diabetes, rheumatoid arthritis, Graves disease, multiple sclerosis, lupus, etc.).
• 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).
• 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.
• Individual has had a weight change of ±4.5 kg (10 lbs.) in the previous 3 months.
• Individual has extreme dietary habits (e.g., Atkins, vegan, very low carbohydrate diet).
• Individual has history of bariatric surgery, is currently taking a weight loss drug, or is actively attempting to lose or gain body weight.
• 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.
• 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.
• Individual has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg) at screening.
• Individual has a history of cancer in the prior 2 years, except non-melanoma skin cancer or carcinoma in situ of the cervix.

Sponsors & Collaborators

• Midwest Center for Metabolic and Cardiovascular Research: lead
• Helaina Inc.: collaborator

Study Sites (2)

Suncoast Research

Miami, Florida, 33135, United States

Location

Health Awareness

Port Saint Lucie, Florida, 34952, United States

Location

Related Publications (1)

• 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.

  PMID: 39465888 BACKGROUND

Study Officials

• Kevin Maki, PhD

  MB Clinical Research & Consulting, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: August 25, 2023
• Study Start: September 6, 2023
• Primary Completion: December 27, 2023
• Study Completion: December 27, 2023
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)