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A 12 week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of Lactoferrin(purified protein extract from whey) on Immune Function

A 12 week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of Lactoferrin(purified protein extract from whey) on Immune Function - A 12 week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of Lactoferrin(purified protein extract from whey) on Immune Function

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000055746
Enrollment
100
Registered
2024-10-04
Start date
2023-11-21
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Single intake of test food: 1 tablet taken once daily with sufficient water Single intake of placebo (control food): 1 tablet taken once daily with sufficient water

Sponsors

Pusan National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Individuals must be aged between 19 and 80 years. Participants must have a peripheral blood leukocyte count of at least three thousand cells per microliter and less than eight thousand cells per microliter Participants must meet at least one of the following conditions: Had two or more upper respiratory infections (such as common cold, acute tonsillitis, acute pharyngitis, acute laryngitis, or acute rhinitis) within the past year from Visit 1. Experienced two or more episodes of stomatitis within the past year from Visit 1. Had a herpes zoster infection within the past year from Visit 1. A perceived stress scale (PSS) score of 16 or higher is required. Participants must provide informed consent and sign the written consent form before the start of the study.

Exclusion criteria

Exclusion criteria: Individuals with diseases affecting immune function, such as leukemia or autoimmune diseases. Individuals with endocrine, respiratory, or musculoskeletal disorders needing treatment. Individuals with severe neurological or cardiovascular diseases, like stroke or heart failure. Individuals with uncontrolled hypertension, defined as systolic blood pressure of one hundred sixty or higher, or diastolic blood pressure of one hundred ten or higher. Diabetic patients with fasting blood glucose of one hundred twenty-six or higher, or those on antidiabetic medications. Individuals with abnormal thyroid-stimulating hormone levels, defined as levels of zero point one or lower, or ten or higher. Individuals vaccinated within two months before Visit 1 that may affect immune function. Individuals with liver enzyme levels exceeding twice the normal limit. Individuals with creatinine levels exceeding twice the normal limit. Individuals taking immunosuppressive medications or immune-enhancing supplements within two weeks before screening. Individuals consuming more than one thousand milliliters of dairy daily. Individuals with severe gastrointestinal disorders or hypersensitivity to dairy. Pregnant or breastfeeding individuals, or those planning pregnancy during the study. Individuals participating in other clinical trials within eight weeks prior to Visit 1. Individuals allergic to any test food components. Individuals with a body mass index of thirty or higher. Individuals consuming excessive alcohol within thirty days prior to Visit 1. Individuals deemed unsuitable by the investigator for any reason. Individuals expected to use prohibited medications during the study.

Design outcomes

Primary

MeasureTime frame
NK cell activity(Effector Cell: Target Cell = 50:1, 25:1, 12.5:1)

Countries

Asia(except Japan)

Contacts

Public ContactMinWoo Jang

Pusan National University Hospital Health Convergence Medicine Laboratory

mtow0620@gmail.com821096262124

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026