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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04930640
Other study ID # BL-PI-SGF200
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 25, 2021
Est. completion date May 26, 2021

Study information

Verified date June 2021
Source Chonbuk National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study was conducted to investigate the efficacy and safety of SGF200 on immune enhancement.


Description:

This study was a 8 weeks, randomized, double-blind, placebo-controlled human trial. 100 subjects were randomly divided into SGF200 group or placebo group. The investigators measured Natural Killer cell activity, Cytokines(IL-2, IL-12, IFN-γ, TNF-α), questionnaire scores of upper airway infection.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date May 26, 2021
Est. primary completion date April 6, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: - Adult men and women over 50 years - After fully hearing and fully understanding this clinical trials, those who agree to voluntarily decide to participate and to comply with the notice Exclusion Criteria: - If screening shows that the white blood cell(WBC) is less than 3000/? or more than 8000/? - Those who received influenza vaccination within 3 months before first intake for test product - Those who have a body mass index(BMI) of less than 18.5 kg / m^2 or greater than 35 kg / m^2 at the screening - Those who have a clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry, musculoskeletal system, inflammatory and hematologic - Those who take a medication or health function food that affects your promotion of immunity within 1 month prior to the screening - Those who have received antipsychotic medication within 3 months before screening - Those who alcoholic or drug abuse suspected - Those who participated in other clinical trials within 3 months before screening - Laboratory test by show the following results - Aspartate Transaminase(AST), Alanine Transaminase(ALT) > Reference range 3 times upper limit - Serum Creatinine > 2.0 mg/dL - Pregnancy or breast feeding - Those who doesn't accept the implementation of appropriate contraception of a childbearing woman - Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
SGF200 group
1 times a day, 1 capsule for 1 time, before breakfast meal, for 8 week
Placebo
Placebo for 8 week

Locations

Country Name City State
Korea, Republic of Clinical Trial Center for Functional Foods Chonbuk National University Hospital Jeonju Jeollabuk-do

Sponsors (1)

Lead Sponsor Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes of Natural Killer cell activity Natural Killer cell activity was measured in study baseline and 8 week. A ratio of effector cell and target cell was 2.5:1, 5:1, 10:1
(Experimental - Effector Spontaneous - Target Spontaneous) / (Target Maximum - Target Spontaneous) × 100
8 weeks
Secondary Changes of Cytokines For blood Cytokines analysis, collect 3 ml of blood in one SST tube for 5 ml, leave at room temperature for 30 minutes for clotting, after then centrifuge at 3000 rpm (or 2000 xg) for 10 minutes.
Inspection item were IL-2, IL-12, IFN-?, TNF-a.
8 weeks
Secondary Changes of Wisconsin Upper Respiratory Symptom Survey-21 Wisconsin Upper Respiratory Symptom Survey-21 consists of seven steps, including individual symptoms, functional quality of life, and overall improvement. Find the sum of the symptom questions and give them the total score. Seek, sum up the questions of life, and get the total quality of life. The sum of the total score of symptoms and the total score of quality of life is also obtained. 8 weeks
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