Effects of Lactoferrin at Two Doses vs. Active Control on Markers of Immune Function
NCT ID: NCT06012669
Last Updated: 2025-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
66 participants
INTERVENTIONAL
2023-09-06
2023-12-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Low Dose
0.34 g Recombinant Human Lactoferrin
Low dose Human Lactoferrin
Dietary Supplement and Food Ingredient
High Dose
3.4 g Recombinant Human Lactoferrin
High dose Human Lactoferrin
Dietary Supplement and Food Ingredient
Active Control
3.4 g Bovine Lactoferrin
Active Control Bovine Lactoferrin
Dietary Supplement and Food Ingredient
Interventions
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High dose Human Lactoferrin
Dietary Supplement and Food Ingredient
Low dose Human Lactoferrin
Dietary Supplement and Food Ingredient
Active Control Bovine Lactoferrin
Dietary Supplement and Food Ingredient
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
45 Years
ALL
Yes
Sponsors
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Helaina Inc.
INDUSTRY
Midwest Center for Metabolic and Cardiovascular Research
OTHER
Responsible Party
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Principal Investigators
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Kevin Maki, PhD
Role: STUDY_DIRECTOR
MB Clinical Research & Consulting, LLC
Locations
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Suncoast Research
Miami, Florida, United States
Health Awareness
Port Saint Lucie, Florida, United States
Countries
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References
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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.
Other Identifiers
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MB-2305
Identifier Type: -
Identifier Source: org_study_id
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