A 8 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of SGF200 on Immune Enhancement
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Changes of Natural Killer cell activity
Study Overview
Brief Summary
This study was conducted to investigate the efficacy and safety of SGF200 on immune enhancement.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
SGF200 group
1 times a day, 1 capsule for 1 time, before breakfast meal[350 mg/day (Bacillus amyloliquefaciens spore 1x10^9 CFU/day, GF101 200 U/day)]
Intervention: SGF200 group (Dietary Supplement)
placebo group
1 times a day, 1 capsule for 1 time, before breakfast meal[350 mg/day (Bacillus amyloliquefaciens spore 0 CFU/day, GF101 0 U/day)]
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Changes of Natural Killer cell activity
Time Frame: 8 weeks
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
Secondary Outcomes
- Changes of Wisconsin Upper Respiratory Symptom Survey-21(8 weeks)
- Changes of Cytokines(8 weeks)
Investigators
Soo-Wan Chae
Principal investigator, Clinical Trial Center for Functional Foods
Chonbuk National University Hospital