Immune HealthNCT06012669
Effects of Lactoferrin at Two Doses vs. Active Control on Markers of Immune Function
A study testing High dose Human Lactoferrin and Low dose Human Lactoferrin in people with Immune Health, run by Midwest Center for Metabolic and Cardiovascular Research at 2 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune Health
- What is being tested?
- High dose Human Lactoferrin and Low dose Human Lactoferrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Sep 2023to 27 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.).
Show all 21Show fewer
- 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.
- Individual has an allergy or sensitivity to any components of the study products.
- Individual has an allergy or sensitivity to yeast.
- 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.
- Individual has been exposed to any non-registered drug product within 30 days of the screening visit.
- 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).
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Suncoast Research
Miami, Florida, 33135
Health Awareness
Port Saint Lucie, Florida, 34952
About this study
Official title: 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.
Read the detailed description
Samples will be retained for possible analyses such as lactoferrin absorption, distribution, metabolism, and excretion (ADME) and gut microbiota.
- Conditions
- Immune Health
- Being tested
- High dose Human Lactoferrin, Low dose Human Lactoferrin, Active Control Bovine Lactoferrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High dose Human LactoferrinDietary supplement
Dietary Supplement and Food Ingredient
Low dose Human LactoferrinDietary supplement
Dietary Supplement and Food Ingredient
Active Control Bovine LactoferrinDietary supplement
Dietary Supplement and Food Ingredient
| Study group | Role | What they receive |
|---|---|---|
| Low Dose | Experimental | 0.34 g Recombinant Human Lactoferrin Receives: Dietary Supplement: Low dose Human Lactoferrin |
| High Dose | Experimental | 3.4 g Recombinant Human Lactoferrin Receives: Dietary Supplement: High dose Human Lactoferrin |
| Active Control | Active comparator | 3.4 g Bovine Lactoferrin Receives: Dietary Supplement: Active Control Bovine Lactoferrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibodies
Change from baseline in anti-lactoferrin antibodies
Measured: 0, 8 weeks
Secondary outcomes (2)
Markers of Immune Function
Change from baseline in markers of Immune Function (such as biomarkers of inflammation)
Measured: 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)
Measured: 0, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start6 Sep 2023
- Primary completion27 Dec 2023
- Study completion27 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Immune HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular Research
- Sponsor type
- University, hospital or other
- Collaborators
- Helaina Inc.
- Responsible party
- Sponsor
- Investigators
- Kevin Maki, PhD, Study director, MB Clinical Research & Consulting, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012669
- Sponsor's protocol ID
- MB-2305
- Status last verified
- Jun 2025
- First submitted
- 16 Aug 2023
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 39465888Peterson 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.
PubMed 42178844
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06012669
- Acronym / sponsor ID
- MB-2305
- Conditions
- Immune Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular ResearchUniversity, hospital or other
- Collaborators
- Helaina Inc.
- Study start
- 6 Sep 2023 (actual)
- Primary completion
- 27 Dec 2023 (actual)
- Study completion
- 27 Dec 2023 (actual)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Samples will be retained for possible analyses such as lactoferrin absorption, distribution, metabolism, and excretion (ADME) and gut microbiota.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose | Experimental | Dietary Supplement: Low dose Human Lactoferrin0.34 g Recombinant Human Lactoferrin |
| High Dose | Experimental | Dietary Supplement: High dose Human Lactoferrin3.4 g Recombinant Human Lactoferrin |
| Active Control | Active comparator | Dietary Supplement: Active Control Bovine Lactoferrin3.4 g Bovine Lactoferrin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High dose Human LactoferrinDietary Supplement and Food Ingredient | Dietary supplement | High Dose |
| Low dose Human LactoferrinDietary Supplement and Food Ingredient | Dietary supplement | Low Dose |
| Active Control Bovine LactoferrinDietary Supplement and Food Ingredient | Dietary supplement | Active Control |
Primary outcome
Antibodies
Time frame: 0, 8 weeks
Change from baseline in anti-lactoferrin antibodies
2 secondary outcomes
Markers of Immune Function
Time frame: 0, 4 weeks, 8 weeks, 12 weeks
Markers of Immune Function
Time frame: 0, 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Results publication: PubMed 39465888Peterson 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.
- Derived from this study: PubMed 42178844Peterson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Maki, PhD study director
MB Clinical Research & Consulting, LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High dose Human Lactoferrin and Low dose Human Lactoferrin in people with Immune Health, run by Midwest Center for Metabolic and Cardiovascular Research at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibodies (time frame: 0, 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06012669, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.