The Efficacy and Safety of SGF200 on Immune Enhancement

Immunity Clinical Trial

Official title:

A 8 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of SGF200 on Immune Enhancement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04930640
• Other study ID #: BL-PI-SGF200
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Immunity

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