UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055746 |
|---|---|
| Receipt number | R000063705 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2024/10/04 |
| Last modified on | 2024/10/04 18:33:02 |
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Basic information
Public title
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
Acronym
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
Scientific Title
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
Scientific Title:Acronym
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
Region
| Asia(except Japan) |
Condition
Condition
N/A
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This clinical trial aims to evaluate the efficacy and safety of lactoferrin (purified milk protein) in enhancing immune function compared to a placebo in individuals with normal or slightly decreased white blood cell counts.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
NK cell activity(Effector Cell: Target Cell = 50:1, 25:1, 12.5:1)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Single intake of test food: 1 tablet taken once daily with sufficient water
Interventions/Control_2
Single intake of placebo (control food): 1 tablet taken once daily with sufficient water
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 19 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Myung-Jun |
| Middle name | |
| Last name | Shin |
Organization
Pusan National University Hospital
Division name
Rehabilitation Medicine
Zip code
49241
Address
179, Gudeok-ro, Seo-gu, Busan, Republic of Korea
TEL
821085130907
drshinmj@gmail.com
Public contact
Name of contact person
| 1st name | MinWoo |
| Middle name | |
| Last name | Jang |
Organization
Pusan National University Hospital
Division name
Health Convergence Medicine Laboratory
Zip code
49241
Address
179, Gudeok-ro, Seo-gu, Busan, Republic of Korea
TEL
821096262124
Homepage URL
mtow0620@gmail.com
Sponsor or person
Institute
Pusan National University Hospital
Institute
Department
Personal name
Funding Source
Organization
LION KOREA
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Pusan National University Hospital
Address
179, Gudeok-ro, Seo-gu, Busan, Republic of Korea
Tel
82512407529
mjkwon@pnuh.co.kr
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
100
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 04 | Day |
Last modified on
| 2024 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063705
