NCT05632341

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 30, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

January 17, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

November 11, 2022

Last Update Submit

February 19, 2026

Conditions

Immune Function

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change amoust of Cytokine analysis (IFN-γ, TNF-α, IL-4, IL-10, IL-12)

    week -2, 0, 4 and 8

  • Change amoust of WBC Count analysis

    week -2, 0, 4 and 8

  • Change amoust of FSS Count analysis

    week -2, 0, 4 and 8

  • Change amoust of upper respiratory infection analysis

    week -2, 0, 4 and 8

Study Arms (2)

GCWB1176

EXPERIMENTAL

1 capsule once a day

Dietary Supplement: Lactococcus lactis

Placebo

ACTIVE COMPARATOR

1 capsule once a day

Other: maltodextrin

Interventions

Lactococcus lactisDIETARY_SUPPLEMENT

1 capsule once a day

GCWB1176
maltodextrinOTHER

1 capsule once a day

Placebo

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seoul St. Mary's Hospital, College of Medicine

Seoul, South Korea

Location

St. Vincent's Hospital, College of Medicine

Suwon, South Korea

Location

MeSH Terms

Interventions

maltodextrin

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2022

First Posted

November 30, 2022

Study Start

January 17, 2023

Primary Completion

January 31, 2024

Study Completion

March 31, 2024

Last Updated

February 23, 2026

Record last verified: 2026-02

Locations

KR(2)