GCWB1176 Evaluates the Effectiveness and Safety of Immune Function

Immune Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05632341
• Other study ID #: GCWB110
• Status: Recruiting
• Phase: N/A
• Start date: January 17, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: November 2022
• Source: Green Cross Wellbeing
• Contact: Yeongmin Kwon
• Phone: +82-70-8892-7881
• Email: ymkwon[@]gccorp.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

Inclusion Criteria:

1. At the time of screening, 19 or 75 years

2. A person with a peripheral blood leukocyte level measured in Visit 1, 3x10^3 cells/µl or more, 8x10^3 cells/µl

3. 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

4. Those with a stress awareness scale (PSS) 16 or more

5. 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:

1. Those who are currently treating drugs due to underlying disease, etc.

2. Hypertension patients (systolic blood pressure 140 mmHg or higher or dichotomous blood pressure 90 mmHg or higher, human application test target 10 minutes stabilized)

3. Patients with diabetes with an fasting blood sugar at least 126 mg/dL or administering urine disease (oral blood sugar, insulin, etc.)

4. Those who are 0.1 UIU/mL or less, or 10 UIU/mL or more

5. Those who have vaccinated vaccines (influenza, corona, shingles that can affect immunity) within 3 months of visiting 1

6. A disease that can affect immune responses such as adult -like and rhinitis

7. AST (GOT) or ALT (GPT) is three times more than the normal upper limit of the embodiment

8. Those who are 1.5 times more than the normal upper limit of Creatinine

9. Those who administered steroids, antibiotics, immunosuppressants, and gastric acid inhibitors within 1 month of visit.

10. Visit 1 person who consumes vitamins, health functional foods that can affect immunity within 2 weeks of visiting

11. 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.

12. Those who complain of severe gastrointestinal symptoms such as heartburn and indigestion

13. Those who are pregnant or have a planning plan for lactation or this human application period

14. 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

15. Those who are sensitive or allergic to food ingredients for this human application

16. Those who have a BMI (body mass index) of 30 kg/m2 or more

17. A person who consumed alcohol within 1 month (30 days) based on 1 visit (man> 210 g/week, woman> 140 g/week)

18. Those who judge that the test person is inadequate for other reasons

Related Conditions & MeSH terms

• Immune Function

Intervention

Dietary Supplement:
• Lactococcus lactis
1 capsule once a day

Other:
• maltodextrin
1 capsule once a day

Locations

Country	Name	City	State
Korea, Republic of	Seoul St. Mary's Hospital, College of Medicine	Seoul
Korea, Republic of	St. Vincent's Hospital, College of Medicine	Suwon-si

Sponsors (1)

Lead Sponsor	Collaborator
Green Cross Wellbeing

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change amoust of Cytokine analysis (IFN-?, TNF-a, 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
Secondary	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
Secondary	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
Secondary	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