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

June 6, 2025 updated by: Midwest Center for Metabolic and Cardiovascular Research

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low Dose
0.34 g Recombinant Human Lactoferrin
Dietary supplement: Low dose Human Lactoferrin
Dietary Supplement and Food Ingredient
Experimental: High Dose
3.4 g Recombinant Human Lactoferrin
Dietary supplement: High dose Human Lactoferrin
Dietary Supplement and Food Ingredient
Active Comparator: Active Control
3.4 g Bovine Lactoferrin
Dietary supplement: Active Control Bovine Lactoferrin
Dietary Supplement and Food Ingredient

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Antibodies
Time Frame: 0, 8 weeks
Change from baseline in anti-lactoferrin antibodies
0, 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Markers of Immune Function
Time Frame: 0, 4 weeks, 8 weeks, 12 weeks
Change from baseline in markers of Immune Function (such as biomarkers of inflammation)
0, 4 weeks, 8 weeks, 12 weeks
Markers of Immune Function
Time Frame: 0, 8 weeks
Change from baseline in markers of Immune Function (such as T-cell responses to lactoferrin and related peptides)
0, 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Midwest Center for Metabolic and Cardiovascular Research

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Helaina Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Kevin Maki, PhD, MB Clinical Research & Consulting, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 6, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 27, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 27, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MB-2305

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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