GCWB1176 Evaluates the Effectiveness and Safety of Immune Function

Study Overview
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Brief Summary
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This human application test was planned to evaluate the effectiveness and safety of immunodefinition compared to the placebo when the GCWB1176 was consumed for those whose white blood cell level was normal or somewhat decreased.

Official Title
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GCWB1176 8 Weeks, Multi -Tube, Randomized Assignment, Double -Eye, Placebo Control Human Application Test for Evaluating the Effectiveness and Safety of the Immune Function

Conditions
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Immune Function

Intervention / Treatment
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* Dietary Supplement: Lactococcus lactis
* Other: maltodextrin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At the time of screening, 19 or 75 years A person with a peripheral blood leukocyte level measured in Visit 1, 3x10^3 cells/μl or more, 8x10^3 cells/μl Those who are more than one of the following standards Those who had more than twice within one year of visiting 1 year. {Common cold, acute tonsillitis, acute pharyngitis, acute laryngitis, acute rhinitis, etc. Those who have stomatitis more than twice within 1 year of visit Those who had Herpes Zoster infection within 1 year of visit Those with a stress awareness scale (PSS) 16 or more A person who agrees to participate in this human application test before the start of the human test and writes a written consent form Exclusion Criteria: Those who are currently treating drugs due to underlying disease, etc. Hypertension patients (systolic blood pressure 140 mmHg or higher or dichotomous blood pressure 90 mmHg or higher, human application test target 10 minutes stabilized) Patients with diabetes with an fasting blood sugar at least 126 mg/dL or administering urine disease (oral blood sugar, insulin, etc.) Those who are 0.1 UIU/mL or less, or 10 UIU/mL or more Those who have vaccinated vaccines (influenza, corona, shingles that can affect immunity) within 3 months of visiting 1 A disease that can affect immune responses such as adult -like and rhinitis AST (GOT) or ALT (GPT) is three times more than the normal upper limit of the embodiment Those who are 1.5 times more than the normal upper limit of Creatinine Those who administered steroids, antibiotics, immunosuppressants, and gastric acid inhibitors within 1 month of visit. Visit 1 person who consumes vitamins, health functional foods that can affect immunity within 2 weeks of visiting A person who has administered or consumed lactic acid bacteria products (4 or more times a week) within 2 weeks of visiting within 2 weeks of visit. Those who complain of severe gastrointestinal symptoms such as heartburn and indigestion Those who are pregnant or have a planning plan for lactation or this human application period Those who have participated in other interventional clinical trials (including human application test) within 8 weeks of visit, or plan to participate in other interventional clinical trials (including human application tests) after the beginning of this human application test Those who are sensitive or allergic to food ingredients for this human application Those who have a BMI (body mass index) of 30 kg/m2 or more A person who consumed alcohol within 1 month (30 days) based on 1 visit (man> 210 g/week, woman> 140 g/week) Those who judge that the test person is inadequate for other reasons

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GCWB1176<br>1 capsule once a day | Dietary Supplement: Lactococcus lactis<br>* 1 capsule once a day<br>|
| Active Comparator: Placebo<br>1 capsule once a day | Other: maltodextrin<br>* 1 capsule once a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change amoust of NK Cell Activity | The comparison of the military comparison for the change before and after the intake of NK CELL Activity is analyzed using the PAIRED T-TEST, and the degree of change between the test group and the control at at each point is Two Sample T-Test or Wilcoxon Rank Sum Test It is conducted to evaluate whether there is a statistically significant difference. | week 0, 4 and 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change amoust of Cytokine analysis (IFN-γ, TNF-α, IL-4, IL-10, IL-12) | The comparison of the military in the before and after consumption is analyzed using the PAIIRED T-TEST, and the degree of change between the test group and the control group at each time is performed by performing the two sample T-test or the Wilcoxon Rank Sum Test according to whether the normality is satisfied. Evaluate if there is a significant difference. | week -2, 0, 4 and 8 | 
| Change amoust of WBC Count analysis | The comparison of the military in the before and after consumption is analyzed using the PAIIRED T-TEST, and the degree of change between the test group and the control group at each time is performed by performing the two sample T-test or the Wilcoxon Rank Sum Test according to whether the normality is satisfied. Evaluate if there is a significant difference. | week -2, 0, 4 and 8 | 
| Change amoust of FSS Count analysis | The comparison of the military in the before and after consumption is analyzed using the PAIIRED T-TEST, and the degree of change between the test group and the control group at each time is performed by performing the two sample T-test or the Wilcoxon Rank Sum Test according to whether the normality is satisfied. Evaluate if there is a significant difference. | week -2, 0, 4 and 8 | 
| Change amoust of upper respiratory infection analysis | The comparison of the military in the before and after consumption is analyzed using the PAIIRED T-TEST, and the degree of change between the test group and the control group at each time is performed by performing the two sample T-test or the Wilcoxon Rank Sum Test according to whether the normality is satisfied. Evaluate if there is a significant difference. If there is a statistically significant difference between the military and clinically significantly significantly significant differences in demographic and lifestyle surveys, ANCOVA can be carried out as a covenant. | week -2, 0, 4 and 8 |