- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06012669
Effects of Lactoferrin at Two Doses vs. Active Control on Markers of Immune Function
February 1, 2024 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
Completed
Conditions
Detailed Description
Samples will be retained for possible analyses such as lactoferrin absorption, distribution, metabolism, and excretion (ADME) and gut microbiota.
Study Type
Interventional
Enrollment (Actual)
66
Phase
- 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 Locations
-
-
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
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
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 |
Intervention / Treatment |
---|---|
Experimental: Low Dose
0.34 g Recombinant Human Lactoferrin
|
Dietary Supplement and Food Ingredient
|
Experimental: High Dose
3.4 g Recombinant Human Lactoferrin
|
Dietary Supplement and Food Ingredient
|
Active Comparator: Active Control
3.4 g Bovine Lactoferrin
|
Dietary Supplement and Food Ingredient
|
What is the study measuring?
Primary Outcome Measures
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
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.
Collaborators
Investigators
- Study Director: Kevin Maki, PhD, MB Clinical Research & Consulting, LLC
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)
September 6, 2023
Primary Completion (Actual)
December 27, 2023
Study Completion (Actual)
December 27, 2023
Study Registration Dates
First Submitted
August 16, 2023
First Submitted That Met QC Criteria
August 22, 2023
First Posted (Actual)
August 25, 2023
Study Record Updates
Last Update Posted (Actual)
February 5, 2024
Last Update Submitted That Met QC Criteria
February 1, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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
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.
Clinical Trials on Immune Health
-
BIO-CAT Microbials, LLCBiofortis Clinical Research, Inc.CompletedImmune Health | Cardiovascular Health | Gastrointestinal Health | Digestive HealthUnited States
-
BIO-CAT Microbials, LLCOhio State University; Biofortis Clinical Research, Inc.CompletedImmune Health | Gastrointestinal Health | Digestive HealthUnited States
-
San Diego State UniversityActive, not recruiting
-
Touro University, CaliforniaKHANA Center for Population Health ResearchUnknownReproductive Health | Sexual HealthCambodia
-
University of California, DavisCalifornia Walnut CommissionCompletedImmune Function | Cardiovascular HealthUnited States
-
Biostime, Inc.University of California, Davis; University of Illinois at Urbana-Champaign; Children... and other collaboratorsUnknownGrowth | Health | Immune FunctionsChina
-
Duke UniversityKilimanjaro Christian Medical Centre, TanzaniaCompletedHIV | Mental Health | Health BehaviorTanzania
-
Tufts UniversityTufts Medical Center; General MillsCompletedDigestive Health and Immune FunctionUnited States
-
Rutgers, The State University of New JerseyNational Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)RecruitingHealth Knowledge, Attitudes, Practice | Health-Related Behavior | Health Behavior, RiskyUnited States
-
Northwestern UniversityTufts University; Weill Medical College of Cornell University; Makerere University and other collaboratorsCompletedHIV | Food Insecurity | Maternal and Child Health | Nutrition | Psychosocial Health
Clinical Trials on Low dose Human Lactoferrin
-
Johns Hopkins UniversityVentria BioscienceUnknownClostridium DifficileUnited States
-
Inner Mongolia Yili Industrial Group Co., LtdCompletedCommon Cold | Human Influenza | ImmunizationChina
-
AM-PharmaCompletedBacterial Infections and Mycoses | Hematopoietic Stem Cell TransplantationNetherlands
-
AgennixCompletedCarcinoma, Renal CellUnited States
-
AM-PharmaWithdrawn
-
AM-PharmaWithdrawnFungal Infection | Bacterial InfectionNetherlands
-
AM-PharmaWithdrawnBacteremia | Staphylococcal InfectionsNetherlands
-
Bispebjerg HospitalCompleted
-
University of Maryland, BaltimoreMedical Technology Enterprise Consortium (MTEC)Completed
-
Stanford UniversityNational Cancer Institute (NCI); AgennixTerminatedTongue Cancer | Recurrent Metastatic Squamous Neck Cancer With Occult Primary | Recurrent Salivary Gland Cancer | Recurrent Squamous Cell Carcinoma of the Hypopharynx | Recurrent Squamous Cell Carcinoma of the Larynx | Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity | Recurrent Squamous... and other conditionsUnited States